A research and development environment presents unique challenges when designing and operating compliance programs. Many risks found in medical device and pharmaceutical commercial operations are found in R&D too. For example, R&D works with both healthcare professionals and healthcare institutions raising concerns about kickbacks, bribes, and corruption. But R&D also has unique risks including:
- Data integrity
- Laboratory controls (a.k.a. Good Laboratory Practices)
- Human Subjects Protection (a.k.a. Good Clinical Practices)
- Animal Care and Welfare
- Using and reusing Human Biological Samples (HBS)
- Medical Affairs (including publications, medical information requests, using Medical Scientific Liaisons (MSLs), etc.
Capitalizing on experience that spans both research and commercial operations, WCG specializes in designing, developing and tailoring compliance programs to meet your R&D operation’s needs and budget.