Tags: Every clinical study has its unique challenges that initially may not have been factored for. Experienced management can help sponsors to address prolonged trial timeline and data quality.
Rare Diseases and Precision Medicine require unique approaches to trial execution and data quality. There could be any number of factors that could necessitate a study being rescued. A study most often needs rescuing when it is in danger of not being completed within an appropriate timeline, its quality is suspect, or unexpected results have caused a regulatory agency to halt the trial and failure to meet the primary efficacy endpoint or to demonstrate value compared to existing therapy.
Rescue support may be as simple as adding third-party function experts to the sponsor project team to analyze the challenge and aid in the management and oversight of the CRO.
Our experienced management team addresses risks such as:
- Delayed enrollment
- Multiple protocol amendments
- Poor patient retention
- Poor data quality
- Prolonged trial completion timeline
- Poor safety monitor
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.