Clinical Process Assessment: Aligning Operations with Trial Scope and GCP Compliance
A recent roundtable on clinical process assessment revealed a growing gap between current clinical operations and the capabilities needed to run today’s complex studies.
Conducting a comprehensive review of processes, systems, and infrastructure ensures alignment with regulatory requirements, compliance expectations, and available resources. A clinical process assessment equips sponsors with the insight to strengthen GCP compliance and optimize procedures proactively.
What Could Happen if There is Misalignment?
Compromised Data Integrity: Inconsistent collection and weak management practices jeopardize reliable results.
Regulatory Non-Compliance: Lack of resources, training, and communication undermine GCP inspection readiness.
Safety Risks: Delayed detection of adverse events compromises participant protection.
Trial Delays & Costs: Inefficiencies stretch timelines and budgets, threatening trial feasibility.
Unnecessary Deviations: Misfit processes create extra corrections that slow inspection readiness.
Weak Sponsor Oversight: Without strong documentation and QMS alignment, oversight of vendors falters.
Conclusion
A robust clinical process assessment helps sponsors align operations with evolving trial demands and regulatory standards. By closing gaps early, sponsors reduce risk, strengthen compliance, and keep trials on track to meet scientific and business goals.
Contributed by Al Pacheco, Director, Business & Technology Consulting, Just in Time GCP
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