Increasingly we see more need and demand for secure collaborative document sharing between sponsors and their partners. Throught-out the Life Sciences community there is a clear momentum to transition away from paper-based trials and adopt technologies such as electronic data capture, electronic patient reported outcomes, and clinical trial management systems, users are embracing these technologies to streamline various pieces of the clinical development process.

Routine activities such as protocol development, site selection and study start-up. Assessment of site feasibility, negotiation of contracts and budgets, planning for patient recruitment, legal reviews and approvals by institutional research boards (IRBs) and/or ethics committees which all involve complex document exchanges and take considerable time and effort.

The use of e-mail as a logical exchange method for clinical-related documents is increasingly diminishing due to the high and increasing regulatory requirements. Online content sharing is critically important and has become a highly effective way for the Life Sciences community to efficiently and securely collaborate. Our solution facilitates efficient business practices and ensures compliance with FDA regulations.

Key features

• Workflow-driven processes
• Collaborative platform
• Immediate access to every document, including CRFs, whether on paper or electronic form
• Real-time visibility to all trial-related documents in a single repository
• Electronic alerts to trial personnel and partners

Technology

• Alfresco - A fully web-based document management system to be used for small and medium-sized companies that primarily want to exchange documents with their business partners and wish to utilize an easy-to-use and very cost-effective solution
• MS Sharepoint - This solution is offered for managing all your clinical documents online. This can be provided as an integrated solution with our regulatory submissions application platform