Good Clinical Practice (GCP) is a legal standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies. From interaction with ethics committees, to drafting a robust protocol, to complex record keeping requirements, this is an area where legal difficulties can bring significant costs and delays.
Most litigation related to clinical trials targets trial sponsors, but researchers, clinicians, nurses and their institutions - and even representatives from research ethics committees – may be implicated as witnesses or parties in legal proceedings.
Outsourcing is a popular solution for dealing with complex issues in GCP and clinical trial conduct. Many innovators rely on Clinical Research Organizations (CRO), and such partners can be vital to steer a clinical trial forward. We advise CROs, medical writing services and their clients, but also institutions and groups who are simply considering assembling information on conducting clinical trials on legal aspects including:
- Contracts for clinical trial related duties and functions
- Research and contract manufacturing agreements
- Data protection and data management law in clinical trials
- Arbitration and litigation of disputes in GCP
- GCP Compliance training, education & refreshers