Ensuring Your Operations Support Your Trial’s Scope
Moderating a recent roundtable discussion on clinical process assessment has highlighted a growing gap between current clinical process capabilities and the requirements needed to execute complex studies.
A comprehensive assessment of clinical processes, systems, and infrastructure is essential to ensure they align with both regulatory requirements to ensure compliance and resourcing structures/limitations.
This type of evaluation provides trial sponsors with vital insights to standardize a proactive approach GCP compliance by optimizing procedures.
What Could Happen if There Is Misalignment?
- Compromised Data Integrity
- Regulatory Non-Compliance
- Safety Risks
- Trial Delays and Spiraling Costs
- Unnecessary deviations
- Insufficient Sponsor Oversight
Compromised Data Integrity
When clinical processes don’t align with trial demands, it can result in inconsistent data collection and weak data management practices. This inconsistency heightens the risk of errors and missing data, compromising the reliability of study results and making it challenging to draw valid conclusions.
Regulatory Non-Compliance
When systems and processes are lacking, it often results in inadequate resources, insufficient training, and ineffective communication. This makes it nearly impossible to maintain proactive GCP inspection readiness and raises the likelihood of costly, last-minute remediation efforts.
Safety Risks
Misalignment in monitoring and oversight can lead to delays in identifying and addressing adverse events, compromising participant safety and undermining the ethical standards of clinical research. This can result in serious consequences for both participants and sponsors.
Trial Delays and Spiraling Costs
Misalignment often leads to inefficiencies, requiring extra resources and time to address operational challenges. These delays can extend timelines and drive-up costs, putting the trial’s feasibility—and the timely delivery of new therapies to patients—at risk.
Unnecessary Deviations
Procedures that aren’t well-suited to an organization’s resource structure or limitations can lead to unnecessary deviations, creating extra administrative work to address and correct them. This added “noise” delays inspection-readiness efforts and distracts teams from focusing on genuinely critical issues.
Insufficient Sponsor Oversight
Remember the trusted adage, “if it’s not documented, it didn’t happen”—a principle that is especially relevant to Sponsor oversight and particularly important when delegating critical trial activities to third-party vendors. Optimizing an organization’s QMS procedures by aligning them with the realities of outsourcing is essential for effective procedural management.
Conclusion
A comprehensive clinical process assessment is vital for equipping sponsors with the insights needed to align operations with modern research approaches and evolving regulations. By proactively addressing identified gaps, sponsors can mitigate downstream risks and more effectively achieve their strategic objectives and go-to-market targets.
Contributed by Al Pacheco, Director, Business & Technology Consulting, Just in Time GCP
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