A leading, global U.S.-based biotech company that delivers innovative human therapeutics, uses the Intralinks platform for the clinical trial safety reporting process. The end result? More efficient processes, and the ability to improve visibility of regulatory compliance. The company is currently running approximately 150 simultaneous clinical trials in over 55 countries.Read Case Study (PDF)
Safety document distribution to investigator sites, institutional review boards (IRBs), and clinical research organizations (CROs) has become more challenging due to the globalization of clinical trials. Additionally, the expanding number of subjects enrolled in development programs has increased the level of complexity of effectively managing the process.
Intralinks Studyspace allows investigators to securely submit reports to sponsors in real-time, speeding information exchange and collaboration when serious events occur. Intralinks Studyspace decreases the time needed to receive and disseminate severe adverse effect (SAE) reports, ensures secure communication, provides automatic notification of reports and receipt, and helps ensure documents are reviewed in a timely fashion. In addition, sponsors of widely dispersed global trials using multinational CROs can track document distribution with full audit trails, and ensure regulatory compliance across multiple jurisdictions.
Additional features include:
- Workflows to support collaboration by automatically routing SAE reports for internal review
- Automated distribution of complete SAE report to investigators, IRBs, and CROs
- Audit reports that maintain records of report distribution, recipient delivery status, document access, and timing to improve compliance
- A centralized, repeatable, scalable platform for managing SAEs
- Connectors to leading safety systems which facilitate the seamless routing of SAEs to the sponsor’s review team for evaluation
Safety Document Exchange in the Global Clinical Research Environment: Secure, Cost-effective, and Well-connected – Not long ago, the public assumed that drugs approved as safe and effective by the FDA were, in fact, safe and effective. But a series of highly publicized product withdrawals and black box warnings given to marketed drugs in recent years has alerted the public and Congress that the FDA must give greater scrutiny to safety signals arising during drug development. As a result, the proper and timely reporting of Serious Adverse Events (SAEs) during clinical trials is under scrutiny.