We work with our clients to define the right technology-enabled risk management processes, key risk indicators (KRIs), quality tolerance limits (QTLs), and assessment/categorization tools that enable risk-based approaches across the company, program, and study levels. These processes allow for earlier detection and mitigation of risks, proactive decision making, and cost-saving operational efficiencies.

At the sponsor, program, and/or study level, we perform a risk assessment with the key stakeholders and vendors to identify the critical risks, thresholds, and mitigations for the clinical trials and new virtual options using an efficient, pre-configured risk assessment and categorization tool (RACT). We outline the risk management strategy and clear risk triage and communication processes in an integrated quality and risk management plan (IQRMP) and update functional plans as needed. We also develop and implement a risk-based monitoring (RBM) strategy/framework that fits into the risk management process.

Our deliverables include:

• Integrated Quality and Risk Management Plan (IQRMP)
• Risk Assessment and Categorization Tool (RACT) alignment across all vendors and stakeholders
• Key Risk Indicator (KRI) Library development and customization per study
• Risk-Based Monitoring strategy and framework development and implementation support

We partner with our clients to develop risk-based audit plans and provide detailed audit feedback that supports continuous improvement and inspection readiness. We conduct cost-effective Computer System and IT Compliance audits for sites, partner technology vendors, and internal processes. We perform audits against 21CFR Parts 11, 211, 312, 820, Annex 11, GDPR and HIPAA as well as international standards such as ISO 14971, ISO 62304 and ISO 13485.  We are well-versed in assessing alignment with Good Automated Manufacturing Processes (GAMP5) best practices.

Halloran designs right sized Quality Management Systems to document processes, procedures, and responsibilities for achieving quality policies and objectives based on the size and outsourcing strategy of our client. We develop quality system documents using our lean principles to guide structure, content, and style. Our quality system design and development support activities include establishing the QMS governance structure and management review processes, establishing quality implementation support across risk management activities, product and process validation, investigations and CAPA, complaint management, Executive Team Quality as a Culture and GxP training programs, and post-market support.

Halloran performs organizational quality assessments to evaluate the level of adherence to procedures and regulatory requirements and determine how effectively the overall QMS or elements of the QMS have been implemented within the organization. Following the assessment to identify these compliance gaps and risks, Halloran develops harmonization plans that support the development, design and implementation of a streamlined and fit-for-purpose QMS with prioritized recommendations for immediate and long-term solutions aligned to the client’s development stage and business objectives.

Halloran facilitates virtual or on-site inspection and audit readiness engagements, helping to prepare our clients for anticipated regulatory inspections (FDA, EMA, MHRA, PDMA, CFDA), diligence by investors, or potential partner evaluations. These engagements include inspection readiness preparedness, mock inspections and audits, storyboard preparation, behavioral interview training, and coaching. Halloran also leads clients through the immediate remediation by authoring responses including strategies for remediation and developing corrective and preventative action plans (CAPA).

Halloran conducts virtual or on-site cost-effective GCP, GLP, and GMP audits of sponsor companies, Contract Research Organizations (CROs), Academic Research Organizations (AROs), Contract Manufacturing Organizations (CMOs), Laboratories, Trial Master Files (TMF), clinical sites, and sponsor processes. Our team is experienced in conducting qualification, re-qualification, for-cause and routine audits across these entities. We partner with our clients to develop risk-based audit plans, identifying immediate and long-term corrective actions and providing recommendations that support continuous improvement and inspection readiness.

Halloran provides GxP (GCP, GMP, GVP, and GLP) quality support for clients of all sizes including the development and implementation of Quality Plans, GxP Training, and ad hoc quality support. Halloran can serve as Head of Quality as well as the Management Representative to implement or maintain the company QMS. Halloran can also provide on demand subject matter expertise across all elements of the QMS.

Halloran supports our clients’ implementation of QMS technology by assessing current state processes and documentation against business needs, regulations and industry best practices. Our expert team will provide an outline of detailed recommendations, watch-outs, and lessons learned for the successful implementation of QMS technology.  We will provide business process support leveraging our industry best practices, systems training, project management, and change management.