A successful clinical trial demands the secure and organized exchange of large volumes of regulatory and safety data among investigators, contract research organizations, institutional review boards and regulatory agencies, usually over an extended period of time. IntraLinks® can help streamline that process in a highly secure environment that fully supports 21 CFR Part 11 and ICH GCP Adherence.

IntraLinks was founded in 1996 in response to the need of financial institutions for a more efficient way to manage the flow of critical business information; our On-Demand Workspaces™ have been widely adopted to facilitate mergers and acquisitions, syndicated loans, commercial lending and alternative investments. These transactions are highly confidential, global in nature, regulated and document-intensive—much like communications that take place in the clinical research community. So it’s not surprising that since 2000, top pharmaceutical research organizations have been using IntraLinks to manage clinical trials, streamline safety reporting and shorten the race to market.

IntraLinks can help you with:

• Secure Document Exchange for Clinical Trial Management
• Regulatory Document Distribution and Collection
• Global Safety Document Distribution and Reporting
• Document Collaboration for Site Contracts and Budgets
• Online, Auditable IRB Review Request and Approval Notification
• Digital Signatures Using SAFE Digital Credentials

Flexible Exchange and Collaboration:

• Alliance Management
• Project Management
• Cross Licensing