Independent, senior-level quality assurance and FDA/EMA inspection-readiness consulting for pharmaceutical, biotechnology, and medical device sponsors — informed by more than three decades of hands-on clinical development and inspection experience.
Panacea Clinical Research provides global quality assurance services to sponsors, CROs, and investigator sites.
Panacea Clinical Research brings more than three decades of experience supporting the clinical development of investigational drugs, biologics, vaccines, and medical devices across Phase I–IV and pilot/pivotal multinational trials spanning the US, Canada, the EU, Eastern Europe, and APAC.
As a recognized subject-matter expert in FDA Bioresearch Monitoring (BIMO) and EMA GCP inspections, Panacea Clinical Research helps sponsors build inspection-ready quality systems, close compliance gaps before regulators arrive, and respond confidently when they do. Engagements range from single directed audits to full quality-system design, TMF governance, and hands-on inspection hosting.
The practice has worked with more than 80 biopharmaceutical and medical device companies — from emerging sponsors filling a talent gap to established organizations preparing for a pre-approval inspection.
When engagements call for it, Panacea Clinical Research draws on a trusted network of senior GCP and quality-assurance experts.
Panacea Clinical Research's core strength: preparing sites and sponsors for FDA and EMA scrutiny, stress-testing programs with realistic mock inspections, and standing at the front of the room to host the inspection when regulators arrive.
Ready investigator sites — private practice, research centers, and academic institutions — for FDA and BIMO inspection: document readiness, source verification, and staff interview coaching.
Prepare sponsor teams, TMFs, and quality systems for pre-approval, pre-NDA, and pre-MAA inspections — defining roles, aligning the inspection narrative, and closing gaps before the visit.
Full mock FDA and BIMO inspections that simulate the real thing — surfacing findings, testing team readiness, and driving CAPAs so gaps are resolved before an inspector ever arrives.
Serve as your on-site inspection host and primary QA liaison during live FDA and EMA inspections — managing document requests, the back room, and Form FDA 483.
A full spectrum of clinical quality assurance services, tailored to the size, phase, and regulatory stage of your program.
Routine, directed, for-cause, and risk-based GCP audits of sites, CROs, vendors, labs, IRBs, and systems — aligned with ICH E6(R3).
Risk-based vendor qualification and sponsor-oversight programs — from CRO, lab, and system selection to ongoing performance and quality monitoring across the supply chain.
Paper & eTMF setup, migration, validation, and maintenance to CDISC/DIA reference models — assuring continuous inspection-ready status.
QMS/eQMS frameworks, SOP gap analysis, remediation and implementation, controlled documents, quality investigations, and CAPA effectiveness checks.
Training-needs analysis and tailored GCP, ICH, monitoring, and site-management modules — plus mentoring for CRAs, auditors, and QA staff.
Authoring and quality review of clinical submission components for regulatory authorities — safety, progress, and study reports.
Assessment and oversight of PV systems, processes, and safety-vendor compliance to protect subjects and satisfy global reporting obligations.
Independent monitoring oversight, vendor qualification, and sponsor-oversight assessment to keep trials adherent to protocol, SOPs, and GCP.
Risk-based, routine, directed, and for-cause audits aligned with ICH E6(R3) — across the full clinical trial ecosystem.
Quality and compliance work spanning a broad range of indications and product types.
Deep, hands-on experience hosting FDA and EMA inspections means gaps are found — and fixed — the way a regulator would see them.
No conflicts, no upsell. Audits and assessments are delivered with the impartiality sponsors and boards can rely on.
You work directly with a principal consultant with 30+ years of experience.
Multinational trial experience across the US, Canada, the EU, Eastern Europe, and APAC.
Flexible engagements — from a single directed audit to a full quality-system build or interim QA leadership.
The goal of every engagement is the same: a compliant, defensible, inspection-ready program.
Founder and Principal Consultant of Panacea Clinical Research since 2000. Before establishing the practice, Lawrence held clinical research, project management, and clinical leadership roles at sponsor and CRO organizations. That path — from those environments to independent quality assurance — grounds every engagement in how clinical trials actually run.
RQAP-GCP
Registered Quality Assurance Professional
Society of Quality Assurance
SQA · Society of Quality Assurance
DIA · Drug Information Association
ACRP · Association of Clinical Research Professionals
Reach out to discuss an audit, an inspection-readiness program, or a quality-system engagement.
Framingham, Massachusetts, USA