Our clinical development experts enhance current development strategies and build new strategies from scratch. Whether our clients are focused on the pathway to the nearest value inflection point or through marketing approval, we will leverage our experience with an assessment of precedence, the competitive landscape, and regulatory guidelines to create the most aggressive, yet feasible, clinical development strategies.

The clinical development plan starts with the end in mind with a target product profile, and will include outlines of key studies, assumptions, risks, timeline, and budget forecasts. We will assess current data packages and development plans to validate assumptions and identify risks and gaps, mitigation strategies, and opportunities to accelerate clinical programs. We build clinical development plans for actionable implementation and, upon request, will defend the plans to our clients’ potential investors and stakeholders. 

A target product profile (TPP) is a critical tool for defining the vision of a product while setting the criteria for success across the development functions. The TPP is the foundation of an overall development strategy, and it drives study design and clinical endpoint selection. If created properly, it will also guide decision making throughout the development life cycle.

Halloran consultants leverage their unique scientific, regulatory, and clinical expertise to define a product’s differentiators. Throughout TPP development, we provide our clients with the strategic direction and subject matter expertise to guide the product’s development journey, leveraging the competitive landscape, regulatory precedence, and industry guidelines to maximize success.

There is a tendency to overcomplicate protocols, ignore risks, capture too much data, and neglect to consider the patient journey. Unnecessary burden on sites and patients can impact recruitment, retention, and the success of studies. Poorly written protocols contain unnecessary redundancies, over-complex study endpoints, and nebulous description leading to deviations, heterogenous interpretations, and uninterpretable data. Collectively these factors will reduce the quality of the data, cause protocol amendments, drive costs up, and prolong timelines. 

Our clinical trial design experts can optimize the design and simplification of studies, including adoption of virtualization and patient centric strategies, to obtain the right data from the right patients as quickly and inexpensively as possible, thereby enabling key decisions to be made with the patient at the forefront. 

Selecting the right CRO and negotiating the optimal terms of the engagement is critical to the timely completion of a high-quality study for the lowest cost. Halloran has routinely provided this level of support for our clients.

We start with a narrow pool of candidate CROs or vendors who meet entry level criteria, provide uniform specifications to facilitate apples-to-apples comparisons, and critically review budgets, experience, data solutions and technology infrastructure, and other factors on a qualitative and quantitative manner. We assist our clients in budget and scope negotiations that help them avoid future change orders or surprises, and incorporate risk sharing incentives and penalties wherever possible.

Managing an outsourced trial or program can be a complicated, intensive task, and adequate oversight is critical to ensure appropriate outcomes are achieved. Halloran consultants have decades of experience in effectively managing hundreds of clinical trials, and we intimately understand what it takes to oversee the clinical trial process and ensure that our clients can deliver on high quality data, on time, on budget, and in a state of inspection readiness.

Establishing and maintaining a robust vendor oversight plan not only complies with industry and regulatory expectations but will improve the integrity and utility of the study data and outcomes. Halloran understands what our clients have at stake, and we take responsibility to work as an extension of their teams to provide the necessary oversight and management of each of the outsourced vendors to keep clinical development on track.

Our clinical program experts assume clinical program leadership and clinical project management roles within our client’s organizations to help them drive their team’s success from strategic planning to implementation. Halloran’s interim program leadership and project management leaders offer our clients a competitive advantage through their insights and learnings from the development of similar types of products in the industry.

Our leaders manage our clients’ organizations, provide coaching, and offer tools and resources to further develop one or more of their existing staff or rising stars. We help our clients build the roles and capabilities within their organizations that are required to stay competitive. In addition, we drive process improvement initiatives to optimize and standardize performance across strategy and operations teams.

Beyond evaluation of intellectual property, scientific soundness, and the commercial market for a life science asset, key elements of a thorough Due Diligence process include assessment of medical need and feasibility of the proposed development strategy including the regulatory and clinical aspects. We help fill the gaps in these critical areas with a Due Diligence assessment led by drug development experts with extensive regulatory, clinical, and quality experience. Our assessment yields greater understanding of the market opportunity in the context of the development landscape and helps our clients arrive at vital go-no-go decisions.