Clinical Study Management

Time-to-market shouldn’t be hindered by paperwork.
Clinical studies in drug development are high cost, high risk endeavors. You’re under intense pressure to fill pipelines and replace expiring blockbusters. At the same time, you're being asked to reduce costs and timelines. Manual and paper-based steps significantly slow the process and introduce compliance and security risks. A paperless study could offer the level of operational efficiencies you need.

Challenges & Opportunities
All phases of a drug’s lifecycle involve the distribution, collection and review of critical documents. Use of overnight mail, email and fax are costly and lack control. Storing and managing paper documents for mandatory retention periods adds to the enormous trial overhead. Gathering metrics by hand on response rates and turnaround is awkward. It makes it difficult to identify targets for process improvement or site personnel who could benefit from additional support. An on-demand, electronic document exchange system could generate significant savings.

Products & Services That Can Help
IntraLinks for Clinical Study Management is a secure, compliant and easy-to-use portal for study teams to manage documents and communicate with study participants. By moving document distribution and collection to a 24/7/365 online environment you accelerate study completion. Improve global site communication. Hasten document exchange. Simplify tracking. And study teams hit key milestones faster. With IntraLinks, you shave weeks or months off the clinical trial process, which translates into thousands, even millions of dollars of cost savings.

• IntraLinks Exchanges makes study communications with all parties efficient and secure, providing a central repository for all study documents and a 21 CFR 11-compliant audit trail.
• Study start-up contracts and budgets can be negotiated and finalized faster, start-up packages can be distributed real-time, and completed documents can be collected in a central, organized location. IntraLinks’ functionality even allows IRBs to review the materials and provide approval via online, speeding site activation.
• Sites can instantly update their 1572s, CVs, medical licenses and IRB approvals on IntraLinks, so the information is always accurate. Study monitors can review these documents and confirm that sites have accessed new forms electronically, instead of sending email inquiries or waiting until the next on-site visit.
• IntraLinks provides the ability to vary permission and access to information based on different user profiles, document protection, placing control of the exchange in the hands of the study team instead of the IT department.
• Neutral solution is not bundled to one specific clinical service provider, enabling IT to offer it as the portal of choice for all company studies, regardless of which CRO might work on a specific study.