GCP Compliance Auditing

Has your company or site been affected by the transformation happening in the clinical research industry? If it hasn't yet, it probably will be soon.

The Changing Landscape

The shift toward Risk-based Monitoring (RBM) is undeniable; the publication of ICH E6(R2) has only accelerated the transition. Pilot studies have been conducted in which mobile health devices stream subject data directly, in real time, to awaiting EDCs. Large pharmacy chains like Walgreens are acting as recruitment agents and study sites. Virtual, siteless trials are being conducted with more frequency. Protocols are being crowd-sourced. Trial Master Files, Informed Consent, study drug labeling, and source documentation are all going electronic. Drugs with ingestible sensors are being trialed and approved. And social media is giving rise to the empowered patient.

You need GCP experts who have a long history of auditing studies that use traditional research techniques. You also want auditors who keep up with industry trends, and who are ready to adapt their QA activities as your research practices evolve.  We do that.

Orphan Drugs, Biologics, and Devices

Maybe you specialize in rare disease studies. If you do, you know that regulatory provisions like Orphan Product designations and Expedited Programs were designed to incentivize and accelerate your research. And they can. But they can’t increase your subject pool. With trials so small, you can’t afford to call into question even one subject record; every data point is critical. We’ve audited numerous drug and device studies for rare diseases so we understand that. We also have experience auditing studies under the Fast Track, Breakthrough Therapy, and Accelerated Approval programs.

Clinical Research Organization (CRO) GCP Audits

A trend towards strategic alliances between large sponsors and large CROs means that competition for the services of large, established CROs is likely to increase. Small and mid-sized sponsors can compensate by emphasizing vendor qualification procedures and contracting with smaller, capable CROs or developing strategic partnerships of their own. During a CRO audit we:

• Tour facility, including IT and document storage facilities
• Review SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations. This includes SOPs for:
  • Clinical trial management
  • Protocol and amendment development and deviation procedures
  • Investigator selection
  • Investigational product management
  • Subject randomization
  • Clinical monitoring, including centralized, remote, and risk-based on-site monitoring procedures
  • Data management
  • AE/SAE reporting
  • IRB communication
  • Regulatory submission
  • TMF organization and management
  • Records management and archival
  • Disaster recovery
  • SOP management and revision
• Assess compliance with SOPs
• Assess vendor qualification, management, and certification programs
• Review qualifications and training of the CRO project team members
• Assess staff workload and turnover rate
• Review Quality Management System, including Quality Manual and Policy
• Review computer system procedures and documentation, including those for security, back up, and recovery
• Review QA unit reporting structure, auditing practices, and CAPA procedures
• Assess any prior FDA 483s, responses, or Warning Letters, if applicable
• Assess medical writing capabilities
• For on-going studies, ensure that the trial is being performed according to protocol and applicable regulations, guidelines, and standards