IntraLinks, a leading provider of critical information exchange solutions, announced on 16 Nov IntraLinks for Study Management, a secure, online platform for managing and monitoring all communication and activity with investigative sites and other outside parties during clinical trials from study start-up through study close-out. The new offering expands the full suite of IntraLinks’ solutions for clinical operations, which accelerates business processes, cuts costs and reduces risks throughout the entire clinical trial lifecycle.

IntraLinks for Study Management specifically helps to:

• Centralise all study-related documents, communication and activity history in an organised, consistent and searchable fashion
• Standardise and automate processes such as contract & budget negotiation, regulatory document distribution and collection and ongoing document exchange
• Eliminate repetitive and redundant site data entry and document submission
• Provide sites with a personalised view of tasks, requests and due dates, with reminder alerts and a secure communication channel to ensure timely site activation
• Monitor process progress with real-time activity dashboards and meet regulatory compliance with detailed access reports and audit trails

IntraLinks, which is already used by the top ten global pharmaceuticals, biotechs and Contract Research Organisations (CROs), also offers a collaborative platform for site recruitment and safety reporting as part of its suite of solutions. IntraLinks for Site Recruitment enables users to eliminate the redundancy and manual tasks related to feasibility survey creation, distribution and collection. IntraLinks for Safety Document Exchange provides a secure environment where safety teams can receive notifications, route them for review, and instantaneously distribute subsequent letters to all parties requiring notification in an intelligent, automated and auditable fashion.

"The clinical research community has trusted IntraLinks for over ten years to securely exchange information and accelerate processes, while upholding quality and maintaining regulatory compliance," said Fahim Siddiqui, executive vice president, product & operations, IntraLinks. "IntraLinks for Study Management expands our offering and enables our customers to use us from start to finish for clinical trials, meeting a critical business need. For example, we estimate that companies can save two million dollars in study start-up costs and reduce cycle time by 50% for an average Phase III clinical trial when using IntraLinks instead of traditional paper-based methods of document distribution, collection and collaboration."