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Six Startup Questions to Discuss with Planned Sites Before Activation  

Site startup for a clinical trial will always be a challenge. Why? While driving the study forward and gathering cross-functional expertise to operationalize a successful study, site startup is comprised of many unexpected hurdles that may get in the way of meeting clinical development milestones. 

Site activation is not an easy or rapid process. Based on a recent experience where the site was held at a well-known institution, it can take approximately nine months to activate even at such an institution using local Institutional Review Boards (IRB). In this example, the institution required multiple committees to review and grant approval to activate the site. Alternatively, even sites willing to use a central IRB with less committee-required approvals can take an ample amount of time. 

When navigating site activation, the following questions will help you manage approvals and contracts, stay on top of the activation process, and maintain development timelines, all while staying ahead of those common hurdles. 

  1. What approvals will need to be in place for your institution to activate your site
  1. What are the meeting dates for each committee?  
  1. What documentation is required for submission to each of these committees and what is the due date based on each meeting
  1. Can submissions occur in parallel with contract and budget negotiations? 
  1. What other site-specific formalities may be needed to activate? 
  1. Once Site Initiation Visit (SIV) occurs, will the site be able to begin screening or are there any other internal activities that must occur before the site is deemed active?  

The important lesson for site startup is remembering every institution is different, and this understanding requires proper planning. Asking critical questions and providing clear communication with the site from the onset is key to planning and meeting deliverables and helping to enable clinical research success. 

Questions about your site activation? Or curious about how to establish a great site relationship from the beginning? Contact Halloran to discuss your challenges and opportunities. We’re here to support you. 

The Pillars of Driving Change with a Patient-Centric Focus 

As a panelist at CORE (Clinical Operations Retreat for Executives) East, hosted in Chatham, Massachusetts, I had the privilege of participating in a lively discussion on the theme of driving change with a patient-centric focus. This session brought together a remarkable group of experts advocating for early patient engagement throughout the entire clinical development process, including meaningful follow-up with clinical trial patients, and suggestions for engagement.  

This is such an important topic as patients are not just part of our industry; they are the very reason for our industry.  

Here are the patient-centricity pillars recapped from our discussion. 

Patient-Centricity is Not Just a Buzzword 

We collectively recognized that patient-centricity goes beyond a buzzword or a passing trend. It is a genuine commitment to prioritizing patients throughout the healthcare and clinical research journey. Moving from buzzword to the meaning of patient-centricity requires action. 

Engage Patients Throughout the Research Process 

It is imperative to involve patients at every stage of a clinical trial. Engaging with patients early, during trial design, and maintaining this involvement during and after the study can lead to better outcomes and improved patient experiences. 

There is Power in Communication 

Effective and transparent communication emerged as a central theme in our discussion. Patients value regular updates on trial progress, and providing plain-language summaries of results helps patients understand the significance of their participation. Engaging patients and obtaining their feedback can also help refine and optimize the research process. 

Tailor Patient Engagement 

It is important to customize patient engagement strategies to fit the specific study type. For example, trials involving extensive patient interaction with a medical device may require a deeper level of patient involvement. Understanding the unique needs of the study and patient population is vital. 

Demonstrate Return on Investment with Patient Engagement 

We explored how investing in patient engagement can lead to tangible returns on investment (ROI). Figures show that such investments result in faster enrollment, fewer protocol amendments, and a smoother research process. The financial benefits are clear, making a compelling case for patient-centricity. 

Build Trust and Credibility 

Beyond financial gains, we emphasized the value of engaging patients throughout the research process; it is about building trust and credibility within the healthcare industry. By actively involving patients, we convey our commitment to their well-being and needs, fostering lasting community relationships.  

This approach promotes a collaborative and equitable environment where every patient’s perspective is valued, regardless of their background or condition. In doing so, we not only enhance our industry’s reputation but also contribute to a more inclusive and effective healthcare ecosystem. It is high time for the industry to recognize the imperative of long-term engagement and embrace the transformative potential it holds, creating a healthcare landscape that truly puts patients at the center of care. 

Lean into the Medical Device Industry Approach 

The medical device industry’s challenges in patient engagement, where the focus may not always be as prominent as in the pharmaceutical sector, were also discussed. Key issues include the struggle to prioritize patient interaction due to the nature of certain devices, which have limited patient engagement compared to continuous medication usage. Budget constraints and shorter development timelines also pose significant barriers to robust patient engagement in the medical device industry.  

However, a growing recognition of the long-term benefits of patient-centered design is gradually shifting the industry’s perspective. By addressing these challenges and taking a more tailored, strategic approach, the medical device industry can harness the invaluable insights of patients, thereby delivering more effective, user-friendly, and patient-focused medical devices that better serve the healthcare ecosystem. It is time for our entire industry to step up and engage in building a future where patient well-being and needs take center stage. 

In summary, our discussions at CORE East brought into focus the multitude of benefits that stem from giving precedence to patients in clinical research, including improved research outcomes, enhanced patient experiences, and more balanced, equitable data, but also the industry-wide credibility and trust it fosters. Figures shared illustrate the ROI of patient engagement, emphasizing the strategic edge gained by embracing patient-centricity. 

We must recognize that patient centricity goes beyond mere words; it is a call to action. As an industry, we have a unique opportunity to build trust by demonstrating our commitment to patient well-being and needs through active involvement. It is not just about ROI; it is about transforming the healthcare ecosystem into an inclusive and collaborative environment. Patient-centricity is not a concept; it is a proven strategic advantage with quantifiable benefits. It is both a moral imperative and a savvy move in the ever-evolving landscape of clinical research. 

Click here to learn more patient-centric tactics and approaches. 

AI-Driven Transformation in Clinical Research 

Halloran’s CORE East, a three-day intensive retreat for clinical operations executives and life science leaders, is the epicenter of a movement aiming to disrupt the traditional landscape of clinical research.  

The best and brightest came together and sought to revolutionize the drug development process and its impact on healthcare. A few sessions emphasized embracing the full potential of artificial intelligence (AI) for efficient clinical operations and outcomes. 

How can this be accomplished? Let us look at the key highlights from this year’s discussions. 

Unleashing Artificial Intelligence Potential 

AI is enhancing clinical research efficiency, facilitating data-driven decisions, and elevating patient care. In particular, the event highlighted how AI could transform routine clinical trial patient interactions into highly personalized and engaging experiences. For example, AI can demystify the lengthy informed consent form for patients, making it accessible and appropriate for its patient populations.  

AI tools can break down language barriers and simplify intricate medical documents, making clinical trial protocols more accessible and efficient for patients. AI can tear down linguistic boundaries by converting complex medical information in real time. It is more than translation; it can be healthcare’s universal language. 

AI is also an accelerator of positive impacts in the healthcare industry. By simplifying complex medical documents and demystifying inclusion and exclusion criteria, AI can streamline patient matching, data analysis, and clinical trial operations and quickly create reliable Clinical Study Report (CSR) documents. 

Personalized Healthcare and Patient Engagement 

AI personalization has the potential to become a dedicated companion throughout the clinical trial journey. It is not just by tailoring content to patient preferences; it is about ensuring a dose of medication is not missed, monitoring vital signs for anomalies, predicting potential health issues specific to the trial, guiding the patient through the process via virtual assistants, and providing real-time data insights tailored to trial experience.  

An AI-driven personalized approach will revolutionize clinical trials, making them not only more engaging but also contributing to better health outcomes for participants. 

AI will also accelerate healthcare processes, from novel therapeutic targets and AI-designed treatments to patient recruitment and document translation, significantly reducing time and effort for the clinical trial sponsor, and bringing novel therapies to those in need faster. 

While AI transforms unstructured data into structured formats and enhances the accuracy of patient lists for clinical trials, we must also emphasize the significant importance of data security. AI tools create secure environments that comply with privacy regulations to protect sensitive patient data, but sponsors must also own and oversee their data. 

In summary, the fusion of technology and healthcare expertise is raising industry standards, calling for our field to embrace change wholeheartedly. The future holds a wealth of opportunities for research and innovation, promising to reshape healthcare for the better. In a world where AI and healthcare intertwine, the possibilities are boundless, if promise is balanced with proper risk management. The adventure of AI-driven healthcare has only just begun, and with CORE East 2023, we have set the stage for this thrilling journey toward AI discovery.  

Stay tuned for more updates as we continue to pave the way forward. 

Getting Practical about Diversity in Clinical Trials  

Clinical trials play a pivotal role in advancing medical research and innovation, serving as the testing ground for new treatments and therapies. However, for clinical trials to be truly effective, they must include a diverse range of participants representing all possible demographics that could potentially benefit from the treatment.  

But disparities in healthcare outcomes among varied demographic groups are alarming. For instance, Black women with breast cancer face a 41% higher mortality rate than Caucasian women and a 39% higher recurrence rate. Moreover, Black women are three times more likely to develop triple-negative breast cancer. These disparities underscore the urgent need for diversity in clinical trials, as current participation rates among Black Americans stand at a mere 3%.  

CORE East, Halloran’s three-day retreat for clinical research and life science leaders, highlighted this disparity during the panel “Getting Practical about Diversity in Clinical Trials.” The discussion aimed to explore the importance of diversity, and barriers to participation, and highlighted the positive role of community engagement in clinical trials. Panelists shared real world success stories, best practices, and actionable recommendations to ensure clinical trials become more inclusive and representative.  

In this article, we explore the importance of diversity in clinical trials, the challenges in meeting diversity requirements, and the critical role of community engagement in transforming the landscape of healthcare research. 

Clinical Trial Challenges, Perceptions, and Recommendations  

The narrative around clinical trials has been historically painted by betrayal and skepticism. What’s behind this?  

One of the biggest concerns in unsupported communities is that doctors don’t often invite them to participate in clinical trials, but if they are invited, they fear they’re going to just get a placebo while still maintaining the responsibilities of a trial patient. This skepticism is largely rooted in miseducation (or stories shared throughout their communities) about clinical trials. While clinical trials are a standard of care option, skeptical communities wouldn’t see it that way because of a lack of opportunity and gaps in health literacy.  

Engaging with diverse communities must begin early in the clinical trial process, involving community leaders and addressing the specific needs and concerns of various unsupported populations. Clinical trials should be presented as a valid treatment option and not as a last resort. By changing the way clinical trials are offered from the onset, we can ensure better participation and more representative results. 

Different groups may require tailored materials that resonate with their unique perspectives and experiences. Medical schools have recognized the importance of clinical research and ethics training, which can help bridge the gap in healthcare disparities. Efforts are also underway to create a database of diverse Principal Investigators, creating a network of Black and Hispanic leaders. 

There are organizations like TOUCH, the Black Breast Cancer Alliance, working to address these challenges by advocating for inclusivity in clinical trials, acknowledging clinical trials are no longer a dirty word, and recognizing the inclusivity problem is the first step.  

Building Community Trust 

In addition, the industry must move from talk to action. But what does that look like? During this session, panelists believe that by educating patients and demonstrating the connections between clinical research and common medications, the building blocks of trust can be built, and myths may be dispelled. 

Trust is built through education and by building relationships, and through those relationships, patients can become more empowered to demand the care they deserve. Breaking down scientific jargon and explaining standard healthcare practices to patients should be the standard. Without trust, the goal of enrolling diverse participants in studies becomes unattainable.  

It’s essential to change the way we communicate about clinical trials, using language that everyone can understand. Clinical trials should be presented as one of the choices available to patients from the moment they are diagnosed, which can lead to better patient outcomes and provide hope for a healthier future. 

FDA’s Diversity Action Plan Requirement  

In April 2022, the U.S. Food and Drug Administration (FDA) issued a draft guidance recommending sponsors develop Diversity Action Plans to improve enrollment of diverse populations in drug and device clinical trials, but questions remain about what should be included in such plans, when and how the plans should be submitted, and best practices for patient engagement and advocacy.  

As per the guidance, the sponsor is asked to include an overview of the disease, a description of the development program inclusive but not limited to how the trial or study may address inclusion of unsupported minority and ethnic populations, goals for enrollment, and strategic operational plan for enrollment including site feasibility, community engagement, and study design optimization. It is critical sponsors interact early with the FDA regarding Diversity Action Plans to allow enough time to modify throughout their clinical development. 

In summary, diversity in clinical trials is not only a moral imperative but a necessity for advancing healthcare. By addressing the challenges, building trust, providing varied treatment options, engaging communities early, and embracing diversity at every level of healthcare research, we can pave the way for a more equitable and effective healthcare system. It’s time to work together to ensure clinical trials truly represent the rich tapestry of our society, leading to better health outcomes for all. 

Connect with us today to talk through your Diversity Action Plan and patient engagement approach. We’re ready when you are. 

How to Fix What’s Broken with Clinical Trial Compensation

What is broken at clinical research sites? This question posed at CORE East, a three-day intensive retreat produced by Halloran and held in Chatham, Massachusetts, sought to gather answers. In particular, the panel “Clinical Research Site Barriers: What’s Broken and Where’s the Opportunity?” led by Katie McCarthy, Chief Innovation Officer at Halloran, brought together industry executives to examine the clinical trial compensation model – one of the areas in need of improvement. 

The problem is that high compensation may serve as undue inducement to participate, while low compensation or reimbursement often leads to patient dissatisfaction and dropout. So, where is the appropriate middle ground?  

In this article, we’ll review trial compensation models, summarize FDA’s latest information sheet on payment and reimbursement, and offer suggestions shared during the panel to move towards a better clinical compensation approach for trial participants. 

Clinical Trial Compensation: A Brief Overview  

Compensation in clinical trials can mean two distinct outcomes – when participants receive monetary or other benefits for their participation in the clinical trial. While this model is an established practice, to this date, we are yet to reach any consensus about the right way of going about compensation or whether it should be practiced in the first place.  

Compensation is paid for reasons like relieving participants of financial sacrifice, acknowledgment of their time and effort, a token of appreciation of the participant’s contribution to medical science, for achieving adequate recruitment in the required time, and more, including cases of trial-related injuries. 

There are several proposed models of making payments to clinical trial participants. The common models include: 

FDA on Compensation Models 

In 2018, the U.S. Food and Drug Administration (FDA) released a final information sheet on “Payment and Reimbursement to Research Subjects.” 

The FDA maintains that paying research participants in exchange for their participation is a common and, in general, acceptable practice. But the agency also recognizes that payment for participation may raise difficult questions that should be addressed by the Institutional Review Board (IRB). 

The amount and schedule of payments should be presented in the clinical trial protocol to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of reimbursement to assure that neither are coercive or present undue influence.  

While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to the FDA, providing that such incentive is not coercive. 

Ethical Considerations  

From an ethical perspective, when the IRB approves a clinical trial protocol that includes the amount and schedule of payments, they do so based on alignment with specific criteria. For example, they will review the risks compared to the benefits of the study, and whether those benefits are towards a participant or the scientific knowledge resulting from the study.  

If the IRB has decided that a protocol is reasonable, the risks are reasonable, and participants can enroll in the study, then offering to pay them for their time and being part of the study does not change the risks and is also considered reasonable. 

But what is, truly, reasonable and fair? How much is enough? Our industry still has a way to go to gain complete alignment. But it starts with understanding regulatory and ethical boundaries, getting to know your patients before they enroll in the trial, understanding what is meaningful to your patients based on their time and efforts to participate in the study, and then compensating appropriately based on their burden and their contribution to the study. 

If you are struggling with your compensation model in your clinical trial protocol or preparing for your IRB review, contact us today. We are here to listen to your challenges and offer solutions. 

Revolutionizing Clinical Trials: A Patient-Centric Approach for a Better Tomorrow

In the vast landscape of clinical research, patients stand as the primary stakeholders, their needs and experiences at the core of the pursuit of better healthcare solutions. This truth was a theme throughout CORE East, a transformative three-day event hosted by the Halloran Consulting Group (Halloran).

In particular, the panel, “Patients and Caregivers: Journeys of Struggle, Strength, and Survival Beyond Science” led by Sheila Gwizdak, Vice President and Head of Consulting at Halloran, highlighted that to improve areas where this truth doesn’t stand up, it is crucial to elevate the power of patient self-advocacy, lean into the role of clinical data, and emphasize trust and inclusivity to move through positive change.

Here, we explore the panel’s insights, and illuminate gaps in the current system, while envisioning disruptive strategies to revolutionize the industry, ultimately delivering patient-centric, meaningful outcomes.

Address the Gaps: Paving the Path to a Better Future

Bridging the Diversity Gap: Beyond mere enrollment numbers, a diverse representation of demographics in clinical trials is essential. Diversity in trials is critical because different people may have different reactions to the same treatment based on their age, gender, weight, race, ethnicity, and other factors. Since clinical trials rely on volunteers to participate, including people from diverse backgrounds can show if the treatments are safe and work well for people from all different communities. Understanding the role of participants and aligning trial goals with their needs is pivotal for meaningful results.

Comprehending Participants’ Reality: Clinical trials should not focus the patient experience solely on compensation. The full experience is about understanding all patient costs — time, money, or resources incurred by participants due to their illness. Recognizing and addressing these costs is fundamental for better representation and a comprehensive understanding of the full patient experience.

Access to Clinical Trials: Improving health literacy and sharing real-life stories from clinical trial participants can enhance the reputation of trials. Storytelling and providing credible disease-related information at the right time, especially after a diagnosis, is vital. Establishing trust within communities also requires a representative approach, featuring similar stories to connect with the audience.

Harness the Patient Voice: A Call to Action

The first step in engaging patients is through education – mindfully equipping them with clinical trials as a healthcare option, when necessary and appropriate, and knowledge about their role in clinical research before they may even begin the trial. When clinical researchers discuss the trial and the patient’s role from the beginning, clinical researchers can align trials with the realities and needs of those they aim to serve. Through communication and feedback, the patient voice can be reflected in the clinical trial design, ensuring the trial reflects the diverse population it intends to benefit.

Patients give their time, energy, and resources to be a part of a trial, and while clinical researchers need their clinical data, they must remember to push past the science and see the patient to build and sustain compassionate, patient-centered trials.

Understand Clinical Data and Alleviating Participation Burden

Transparency and clear communication with patients about the clinical data are essential for patient engagement and satisfaction throughout the lifecycle of the trial. As clinical data is essential to the health of the trial, clinical researchers must move beyond the science and not treat the patient as ‘data.’ But what does that look like?

For data to be retrieved, researchers must be aware of all the additional burdens that are placed on the patient, ranging from the location of the trial site to specific requirements for medication storage. An upfront understanding of these aspects, and an even deeper understanding of where flexibility and pivoting can come into play, fosters trust and creates a more inclusive and patient-centric environment.

Foster Patient Trust: Building Bridges of Confidence

Trust forms the foundation of successful clinical trials – trust in healthcare providers, sponsors, and researchers – to enroll and stay enrolled. Though we cannot change a patient’s prior healthcare or clinical research experience, we can make a different in the future.

Trust begins with the initial point of contact – the clinical research awareness point. If you are unsure about the best approach for your population, connect with patient advocacy groups and discuss approaches and strategies to build bridges of confidence. All these efforts will ultimately increase participation rates, engagement, and patient satisfaction.

Drive Change: A Patient-Centric Approach

To revolutionize the industry, we must shift focus from mere enrollment numbers to a more patient-centric approach. Meaningful communication with patients, authenticity across studies, engaging patient advocacy and community leaders early in the process, and ensuring patients are at the forefront of the clinical research planning are key elements to drive positive change.

Patients and caregivers should derive substantial benefits from sharing their stories with clinical researchers because it will help them be viewed as field experts, understand the drug or device development process, and have their narratives translated into case studies that drive better outcomes. Fair compensation and full comprehension of the drug or device development process add further value to their contribution.

We believe the future of clinical trials lies in a patient-centric paradigm, where the patient’s voice, needs, and experiences take center stage from the onset. By recognizing their role as active participants and collaborators, understanding the burdens they face, and establishing trust and inclusivity, we pave the way for an industry that truly serves the people it aims to help. Embracing disruptions for change and ensuring patients and caregivers are the focal points in this journey will create a brighter, more inclusive future for clinical trials.

If you’re struggling to adopt a patient-centric approach in your clinical development plan, or want to learn more about patient engagement and patient diversity, contact us today.

This is How We Positively Disrupt Clinical Research

Life science executives recently convened in Chatham, Massachusetts, for the 15th annual Clinical Operations Retreat for Executives (CORE East), a transformative event hosted by Halloran Consulting Group. What makes this event transformative? From the attendees’ perspectives, this event fosters off-the-record conversations and encourages a unique atmosphere of collaboration and openness among industry leaders so we can individually do our part to collectively improve the business and approach to clinical development.

The three-day event proved exceptional this year, with unprecedented levels of collaboration, authentic discussions, and a shared motivation to revolutionize our approach to clinical development. Each year centers around a theme, and this year focused on ‘clinical operations: spearheading disruptions to accelerate change.’ The panels and fireside chats moved beyond what is considered traditional clinical operations and highlighted a cross-functional, end-to-end clinical development process that challenges our standards and pushes for smarter, more efficient approaches. This is where we must continue to grow as an industry.

As you look to positively disrupt your clinical research processes in 2024 and beyond, we hope you can leverage these three key lessons from our CORE East 2023 program.

Trust is Key to Patient Centricity and Diversity – Never Lose Sight

Patient stories shared at CORE East underscored a universal truth – trust is the bedrock of healthcare. During the presentation, “Compassion and Empathy: Finding the Missing Link to Achieve Powerful Clinical Study Design,” the team at Clario shared a concerning statistic: “78% of people have limited or no trust in pharmaceutical companies.” Though we cannot change our past, we must let this stark reality sink in and lean into the call for a paradigm shift in our approach to clinical trials.

The objective is not just increased trial enrollment, but an entire healthcare paradigm that prioritizes the well-being and satisfaction of those it serves. To be better as an industry, we must prioritize patient needs over business metrics and ‘check the box’ processes, focusing on creating a trial experience founded on compassionate communication, transparency, and patient input. Elevating the patient and caregiver experience requires a commitment to education, empowering them with knowledge for informed decision-making, and connecting with them in ways that are centered and compassionate every step of the way.

Embrace Artificial Intelligence for Clinical Development Efficiency

Although our industry has embraced AI adoption in discovery and early clinical research, there’s hesitancy in applying AI models throughout the entire clinical development lifecycle. Though the integration of AI in clinical research is imperative for enhancing clinical development efficiency, there are sticky misconceptions that often prevent AI usage.

Demonstrations at CORE East showcased the transformative power of AI at various complexity levels from translating protocols into multiple languages within minutes to simplifying complex information for broader comprehension, exemplifying we can start small and still reap big benefits. For example, a clinical research summary can be drafted to a specific education level within minutes. While this AI-enabled outcome does not ‘do’ the job for a clinical researcher, it gives them a head start and saves significant time, especially if clinical summaries are a part of their daily routine.

You may be wondering, ‘where can I start at a beginner level?’ Think of what is consistently time-consuming, like drafting clinical summaries, and discover an AI tool to enable efficiency for that task. Just begin with one time-consuming task.

Embracing AI tools can dramatically decrease operational burdens, but it requires a departure from traditional approaches. It requires that we start somewhere, as seen in the example above, then evaluate the outcome and assess for additional task-based needs that will bring additional efficiency and positive outcomes. As you consider adopting new AI models, you and your team may face resistance from those in your organization and will need to navigate the pitfalls and misconceptions around data quality, data privacy, and job loss as moving through these barriers are crucial steps towards realizing the immense potential of AI in clinical research.

Streamline Clinical Trial Vendor Selection for Study Start Up Efficiency

The process of selecting and qualifying vendors for clinical trials is cumbersome and expensive. As shared during the event, research by Ken Getz and his team at the Tufts Center for the Study of Drug Development indicate vendor qualification takes an average of four and a half months for a single service provider.

Qualifying and selecting the right vendor and negotiating optimal terms of the engagement is critical to the timely completion of a high-quality study. During this long four-and-a-half-month process, clinical trial sponsors will need to meet with a pool of vendors who meet their criteria, provide uniform specifications to facilitate comparisons, assess capabilities, critically review budgets, examine expertise and experience, assess data solutions and technology infrastructure, and other factors including their reputation in a qualitative and quantitative manner.

Collaboration between sponsors and vendors as partners with open communication about needs and expectations is a key aspect of streamlining the process. Keep in mind that centralized approaches or risk-based models can focus efforts on what truly matters for a given study and may narrow your vendor options. While full standardization might be challenging due to the diversity of studies you’re managing, there are clear opportunities to optimize elements of the vendor qualification, selection, and management process, but this approach calls for an industry-wide shift and a willingness from stakeholders to collaborate toward shared goals of quality, efficiency, and ultimately, patient benefit.

In conclusion, CORE East 2023 facilitated valuable insights and ignited a collective commitment to reshape the future of clinical development. As industry leaders, it is our responsibility to do our part to heal the trust issues found in clinical research, move beyond standard operations, leverage AI to tap into enhanced efficiency, and streamline processes for the betterment of those we serve. The question now is, are you ready for the transformative journey ahead? The attendees at CORE East certainly are.

Halloran is available to learn about your pressing clinical research challenges and walk your journey with you. Contact us today.

Raw Materials Control for Biotechs (Part 1): Pre-Clinical Development Considerations

The product development stage, commonly referred to as pre-clinical development, precedes launch of an Investigational New Drug (IND) submission, or equivalent regulatory submission in support of conducting a phase 1 clinical study. This stage is rife with critical decisions for chemistry, manufacturing, and controls (CMC) which can impact the quality of the drug substance (DS) and drug product (DP) that early-stage biotech companies intend to use for their phase 1 clinical trial. These decisions include design and execution of the manufacturing processes, the types of quality control (QC) tests required for in-process, lot release and stability testing, the acceptance criteria to be established for lot release and stability, choice of container/closures, monitoring and improving impurity profiles, design of the stability program, choice of material to be used in IND-enabling studies, and more.  

One of the most critical and impactful of the CMC decisions that an early-stage biotech company will make is the choice of the quality of the raw materials used to develop the DS and DP manufacturing processes. It is often the case that raw material selection is based on research studies conducted early in process development by individuals not familiar with the requirements of current Good Manufacturing Practices (cGMP) – the cornerstone of a successful clinical development program. As a result, critical process development work may utilize raw materials posing regulatory challenges to the company when they submit their IND application for U.S. Food and Drug Administration (FDA) review.

These challenges can include:

This article will discuss how early-stage biotechnology companies can address these pitfalls and establish a solid cGMP foundation for their raw materials control program. While the focus is on cell and gene therapies (CGTs), the content generally applies to other types of early-stage biological therapies.

Let’s start with definitions:

A Raw Material is a general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or drug substance.2

A Starting Material should be a substance of defined chemical properties and structure. A starting material is incorporated as a significant structural fragment into the structure of the drug substance. “Significant structural fragment” in this context is intended to distinguish starting materials from reagents, solvents, or other raw materials.3

An Excipient is a raw material formulated with drug product that is intended to enhance DP properties such as stability, bioavailability, half-life, etc.4

Evaluation of Raw Materials to be Used During Process Development

Early-stage biotech companies should carefully evaluate raw materials intended for use in their manufacturing process. This evaluation is best conducted as a formal risk assessment with the goal of identifying raw materials critical to the manufacturing process with the requisite quality to ensure successful execution of that process and with an acceptable safety profile.5-7If carefully documented, the risk assessment can potentially be used when approaching the FDA regarding raw material safety designations in later stages of development.

Consider including the following elements in the risk assessment:

For example, mammalian cell bank-derived monoclonal antibodies (mAbs) used for immunoselection of cells or proteins as part of cell therapy DS manufacture pose regulatory challenges including qualification of the master/working cell banks, inactivation/clearance of virus from the mAb manufacturing process, removal of process residuals (column leachates, host cell protein, host cell nucleic acid, etc.) Before using a mAb in a DS manufacturing process, it is essential to understand how the mAb is manufactured, tested, and released. The mammalian cell bank used to produce the mAb should be fully characterized for adventitious agents, and manufacturing process steps claimed to clear/inactivate a virus should be verified by a viral clearance/inactivation study. Lot release should be based on an assessment of mAb identity, potency, purity, and stability.11

Raw materials sourced from bovine or porcine tissues are scrutinized by regulatory authorities as they can be a significant source of adventitious agents. For example, the manufacture of stem cell therapies typically requires the use of fetal calf or fetal bovine serum (FBS) in the cell culture media. When selecting a source for this material, the following information should be confirmed: 1) Source of the FBS, provided in a Certificate of Origin (CoO), (fetuses of healthy, prepartum cows deemed fit for human consumption through ante- and post-mortem inspection by licensed veterinarians that has been collected in government inspected and registered abattoirs as well as the geographic location of the source herd); 2) Ability of the manufacturing process to clear/inactivate virus. Filtration, heat inactivation, gamma irradiation or a combination thereof are typically used; 3) Testing and acceptance criteria should meet regulatory standards.12,13

Certificates provided by the manufacturer should include a Certificate of Analysis (CoA), a Certificate of Origin (CoO), including a Transmissible Spongiform Encephalopathy/Bovine Spongiform Encephalopathy (TSE/BSE) compliance statement. A CoO should indicate the source material used to generate the raw material (biological, animal, fermentative, mineral, natural, synthetic, or vegetable). The TSE/BSE statement should comply with the European guidance on minimizing the risk of transmissible spongiform encephalopathies contaminating medicinal products.14

Some vendors will combine the CoO and TSE/BSE compliance statements in a single document. An FBS manufacturer may have obtained a Certificate of Suitability from the European Directorate for the Quality of Medicines and Healthcare (EDQM), confirming compliance of the raw material with specific monographs of the European Pharmacopeia. This certificate verifies that a raw material has been manufactured and tested to exacting standards with an excellent safety profile. If available, this certificate should be provided and reviewed.

Whenever feasible, consider replacing bovine- or porcine-derived raw materials with raw materials that pose less of a safety risk. For example, porcine trypsin can often be replaced with a comparable protease or collection of proteases derived from a non-animal source. Bovine serum albumin (BSA) can often be replaced with human serum albumin (HSA). There is a commercially available HSA that is FDA/European Union approved as a biologic injectable product. Empirically confirm that every raw material candidate is suitable for use in the manufacturing process before an established raw material is replaced. Don’t assume that a higher purity raw material will necessarily work as well or better in your manufacturing process than the current grade in use.

For synthetically produced raw material, evaluate the impurity profile. Confirm that typical impurities such as residual solvents and elemental impurities are measured at levels that do not raise safety concerns.

For a raw material not intended for manufacture of a biologic therapy, it is essential that the risk assessment evaluate the material’s manufacturing process, impurity profile, stability profile and potential breakdown products that could introduce contaminants into the DS/DP process stream, posing an unacceptable safety risk. If a compendial chapter exists for this raw material, then consider executing the tests described in the compendial chapter and confirm that all compendial lot release criteria have been met before determining if the raw material is suitable for use in your manufacturing process.

Evaluating Raw Material Suitable for Use in the GMP Manufacturing Process

Consider the following:

Even if a raw material lot release specification is not changed by the manufacturer, the manufacturing history for this raw material may indicate a clustering of acceptable test results that do not challenge the limits of a particular specification. If lots of raw material approaching those limits have not been evaluated in the DS/DP manufacturing process, then a scenario could arise in which a released lot of raw material testing at the upper or lower limit of one or more release criteria, does not perform well in the DS/DP manufacturing process.


A properly executed risk assessment will take time and effort. At a minimum, it should include input from quality assurance, regulatory, and a technical subject matter expert familiar with the manufacturing process and the raw materials used in that process. Depending on the scope of the risk assessment and the stage of clinical development, it can also include input from manufacturing, quality control, supply chain, and materials management. Conclusions should be scientifically sound and compliant with cGMP.

You may decide to include a subset of the factors described in this article in your risk assessment. However, when building your raw materials control program, you should be mindful of all these factors.

The output from a well-executed risk assessment can circumvent potential regulatory issues arising from raw material purchasing decisions, saving significant time and money by avoiding costly raw material changes later in process development.

Part two in this series will address general raw materials control considerations during clinical development.

Contact Halloran for your pre-clinical raw materials control program and regulatory risk assessment needs.


  1. FDA Guidance for Industry: “Immunogenicity Assessment for Therapeutic Protein Products,” August 2014. URL:
  2. ICH Q7 “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients,” September 2016. URL:
  3. ICH Q11 “Development and Manufacture of Drug Substances (chemical entities and biotechnological/ biological entities)” November 2012. URL:
  4. FDA Guidance for Industry: “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),” January 2020. URL:
  5. USP<1043> “Ancillary Materials for Cell, Gene, and Tissue-Engineered Products” USP 43/NF 38; for the purposes of this discussion ‘ancillary materials’ are synonymous with ‘raw materials.’
  6. “Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations,” Cordoba-Rodriquez, Ruth, 15th WCBP CMC Strategy Forum: Raw Material Control Strategies for Bioprocesses, 2009. URL:
  7. BioPhorum “Raw Material Risk Assessments – A Holistic Approach to Raw Materials Risk Assessments Through Industry Collaboration,” September 2019. URL:
  8. U.S. FDA Guidance for Industry: “Drug Master Files,” October 2019. URL:
  9. ICH Q5D “Derivation and Characterization of Cell Substrates used for Production of Biotechnological/Biological Products,” July 1997. URL:
  10. ICH Q5A(R2) “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin,” September 2022. URL:
  11. FDA Guidance for Industry: “Monoclonal Antibodies Used as Reagents in Drug Manufacturing,” March 2001. URL:–Monoclonal-Antibodies-Used-as-Reagents-in-Drug-Manufacturing.pdf
  12. 9 CFR 113.53 “Requirements for Ingredients of Animal Origin for Production of Biologics.” Updated as of September 2023. URL:
  13. USP<90> “Fetal bovine serum-Quality Attributes and Functionality Tests” USP 43/ NF 38; for all other types of bovine sera refer to the general information chapter USP<1024> “Bovine Serum” USP 43/ NF 38
  14. “Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products,” May 2011. URL:
  15. A suitability assessment should include verification that the raw material does not interfere with microbial growth in the case of the sterility or bioburden test or enhance/inhibit the endotoxin assay. If mycoplasma is tested per USP<63>, then verification that the test article does not interfere with mycoplasma growth is essential

Are You Planning for Success? Essential Role of the Program Manager 

Small life science companies often need to ‘do more with less.’ Leaders of these companies must seek ways to trim costs without sacrificing quality and speed. As you build your development team, you may be tempted to forgo hiring a Program Manager, but that decision may create less-than-desirable results. 

Leaders of life science companies, especially leaders of startups, often have misconceptions about the role of a Program Manager, believing these individuals predominantly schedule meetings, take minutes, and develop timelines. Successful leaders understand a strong Program Manager can advance their product through all stages of development.  

A strong Program Manager: 

While this list is not exhaustive, it does provide insights into how an effective Program Manager can serve as a flexible partner in reaching a company’s development goals. 

You may not be ready to hire a full-time Program Manager; however, consulting groups like Halloran offer Program Management Consultants who can leverage their experience and expertise and dedicate the time necessary to reach your development goals with maximum efficiency and in the most cost-effective manner possible.  

About Halloran’s Program Management 

An effective Program Manager brings deep experience and valuable skills to support life science companies in achieving their goals as efficiently as possible. They strategize and lead, build and execute development plans, provide tools and templates to facilitate workflows and utilize effective team management techniques throughout all stages of a company’s product and portfolio development. 

Halloran’s Program Managers define the strategy within their clients’ cross-functional teams and lead the development program through execution. Halloran’s Program Managers offer their clients a competitive advantage through their integrated insights and learnings from the development of similar types of products in the industry. 

Ready to Learn More? 

Read our Program Management case studyTurning Drug Development Chaos into Order for an NDA.   

Contact Halloran today to evaluate if Program Management consulting is right for you. 

So, You Have Veeva! Four Tips to Maximize Your Value

The use of Veeva systems, a suite of clinical trial solutions, continues to grow. Veeva’s products offer robust functionality, a clean user interface, and excellent reporting capabilities, making their products an industry favorite for small and large life science companies.

However, companies must be prepared for all the changes that come with implementing a new Veeva system that occurs during the planning phase, launch, user adoption, and beyond. Here are our four tips to maximize your Veeva system usage and prevent unnecessary complications along the way.

Tip 1: Define the Various Business Processes

Once Veeva is purchased, it’s important to recognize the various business processes that will need to be defined and finalized during the planning phase. During this phase, it’s critical to consider if the business is ready and prepared for change. Even before a company kicks off its Veeva implementation, the company must begin to plan.

The first step is to define the decision-makers and key stakeholders responsible for crafting the new business processes. An impact assessment should be conducted to gauge the impact the new system will have on existing standard operating procedures (SOPs), policies, and more. In addition, discuss new processes needed to support the administration of the system, and identify if there are existing processes that must be adapted to system functionality (i.e., trial master file inspection readiness reviews).

Secondly, identify the end user community that will define the communication needs throughout the implementation. Strong communication throughout and post-implementation helps users adopt the system and manage change.

Finally, companies must think about the management of the system post-implementation. Planning prior to starting the implementation can help ensure the implementation goes smoothly and cuts down on timeline delays.

Consider asking the following questions:

Many times, companies will find they must also migrate data from an external source (i.e., from a Clinical Research Organization) into their new Veeva product. During the planning phase, time must be taken to define the scope of the migration and consider how much data must be moved, if the data is clean, and how much data needs to be mapped to a new location. An inventory of the data must be defined. Finally, the business will need to define a migration strategy and ask if there are any critical milestones that will impact moving data such as an inspection or database lock.

Tip #2: Optimize Compliant Implementation Activities

Validation of a GxP – a set of regulations and quality guidelines formulated to ensure the safety of life science products – software solution is a must in the life sciences industry, but how far must an organization go with a solution like Veeva? Well, that depends. Consider if you are implementing the solution completely out of the box or if you are adding customization. The amount of customization will impact the validation approach.

Veeva offers a robust validation package, but every organization must follow its SOP governing software validation for GxP systems. Many companies in the life science industry can leverage a Veeva product with few to few additional updates, while others may want to bring the entire validation effort in-house or through a hybrid model. The choice depends on a company’s requirements for validation, though there should always be some additional due diligence to provide objective evidence that the solution matches its intended purpose.

Tip #3: Prioritize Effective Change Management

One of the most common reasons software implementation does not achieve its desired outcome is poor change management, including lack of stakeholder buy-in, inadequate resources, unrealistic expectations, misaligned processes, and resistance to change. This outcome leaves the newly implemented platform unadopted by its user community.

All these challenges can be mitigated through a solid change management program. Change management must be approached through a structured, dynamic, and multi-format process that leverages a set of standardized, industry-accepted tools to prepare, equip, and support individuals through their adoption journey. Companies must navigate the stages of defining success, assessing individual and organizational change readiness, analyzing risk, and mapping impact to design a change management and communication plan that will support sustained adoption.

Veeva provides an industry-leading platform for life sciences, but to realize the full value of such an investment, companies will need the support of experts who have experience in facilitating systems, processes, and structural implementations.

Tip #4: Maximize Veeva Post-Implementation

Optimizing a Veeva solution after implementation will help ensure its continued effectiveness, compliance, and efficiency. Often, Veeva is implemented quickly to support a specific time-sensitive need, and unintentionally, additional capabilities are typically overlooked. When a primary use case is addressed and the user community has gained experience with the solution, that is the time to consider additional capabilities and use cases that will benefit an organization.

However, just because the solution can do something doesn’t mean it’s right for any organization. This is why it’s important to gather feedback from users. Considering asking the following:

Review if there are additional modules or add-ons worth investigating. Because Veeva sits on a single platform, subsequent Veeva modules may not require the recreation of core data since it already exists in another module, enabling faster setup times or more seamless access to various data. Because there are numerous options, it’s best to consult with experts, whether internal or external, to ensure the right additions are selected at the most optimal times.

To maximize your Veeva adoption, implementation, and next stage of success, contact Halloran. We’re ready when you are.