COVID19 has affected almost every aspect of the clinical trial research work. Delayed or canceled trials, a shift to remote trial management, reduced staff and patient availability, and a myriad of other changes have significantly impacted sites’ work. Compliance hasn’t been held harmless; in fact, challenges in compliance during the global pandemic have been profound for sites, CROs, and sponsors alike. Common research site compliance issues might include:
- Confidentiality challenges resulting from staff’s remote work environment
- Changing regulatory environment and compliance oversight
- Telehealth challenges
- Protocol adherence resulting in care and billing gaps
- Parity in regards to patient care, drug delivery, and other patient-centric operations
These changes have raised critical questions for both large and small sites about how clinical research operates, specifically, will these changes permanently affect work, and have they uncovered any benefits in compliance efficiencies. There are ways for sites to address compliance challenges, even in the face of continued issues due to COVID-19. A key first step is to assess how your research organization is executing its compliance work, the company culture, and what tools will help achieve both research and compliance objectives.
To that end, convene your research site leadership to:
- Analyze what has worked well over the past year; identify times that your team was working with less and doing more and then try to maximize the operations allowed efficiencies
- Document new long-term or permanent compliance and regulatory requirements; align policies and operations as appropriate
- Assess necessary policy changes; these should both mitigate challenges and leverage key learnings to enact better overall policies for the organization
- Apply realized efficient and effective compliance procedures
- Engage staff for input and ensure comprehensive information sharing on any organizational changes
- Assess what areas of your work need refined planning and new strategy development (e.g., organizational go-forward plans for decentralized trial management)
Check out our “Challenges in Compliance Post-COVID 19” webinar for more information, including a comprehensive guide at strategies for compliance success, and see how the right CTMS can help your site achieve its goals.