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)
On an industry-wide basis, clinical trials often fall behind their timelines from the very beginning — during protocol development, site selection, and study start-up. Keeping track of a growing number of study start-up documents across multiple studies, with many, sometimes even thousands of clinical sites while ensuring the most recent versions are used is no small feat.
Intralinks Studyspace improves operational efficiency, reduces costs, and shortens document review cycles involved in clinical trials by supporting the creation of secure investigator portals. Intralinks Studyspace enables you to better manage the distribution, collection, and tracking of critical information related to site recruitment, site activation, and safety while also adding a layer of security to the process. From start to finish, Intralinks Studyspace improves communication, collaboration, and document exchange between everyone involved in a clinical trial — from study team personnel and clinical research organizations to investigative sites and IRBs.
Additional capabilities include:
- Shorten the site recruitment process by managing the distribution and collection of feasibility surveys online in a secure, centralized location
- Track the status of site surveys so you can follow-up and get sites on boarded quickly
- Distribute and collect regulatory documents such as 1572s, investigator brochures, and study protocols online to streamline the process
- Keep studies on track , gain real-time visibility into who accesses and reviews content to ensure follow-up action is taken
- Provide investigator sites with a personalized view of tasks, requests, and due dates for easy study management
- Send reminders and alerts when documents are due, or ready for review
- Ensure that sensitive patient information is secure, and can’t be shared with unauthorized parties with role-based permissioning and digital rights management
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.
Document Exchange Portals for Clinical Studies – Biopharmaceutical companies are facing intense financial pressures due to looming patent expirations, weak drug pipelines, and heightened competition. This tough scenario is driving them to explore strategies to improve operational efficiencies in clinical trials with a goal of speeding drugs or biologic treatments to market. This white paper makes the case for use of an online portal for clinical trials, a technology that has moved beyond the introductory stages, but remains early in the adoption cycle for the life sciences industry.