Medidata Solutions Partners with Veeva Systems to Bring Integrated eTMF to the Clinical Cloud

NEW YORK - (BUSINESS WIRE) - Veeva Systems has partnered with Medidata Solutions (NASDAQ: MDSO) to offer the life science industry's first cloud-based end-to-end solution that integrates clinical documentation and trial development. The two companies will integrate Vault eTMF, Veeva's electronic trial master file (eTMF) content management application, across the Medidata Clinical Cloud, offering life science companies and their global partners a complete clinical technology solution with a searchable central repository for all clinical documentation.

• "Within the industry, there is an emerging demand for an eTMF to more consistently manage documents within a clinical trial," said Alan S. Louie, Ph.D., research director, IDC Health Insights. "With the industry shift away from individual applications to more comprehensive eClinical solutions, seamless integration of applications and features such as eTMF into existing eClinical platforms should help leading life science companies to more fully and transparently manage overall trial efforts and improve process efficiencies."

As clinical trials become more and more complex, the need for dependable document storage combined with real-time data accessibility is vital. The partnership will meet this need, advancing technology platform offerings in clinical development by facilitating efficient management of the trial master file collection. The integrated solution also provides secure document exchange between sites and sponsors, reducing the need for separate enterprise collaboration systems and portals. The collaborative nature of the clinical research team also demands a solution that is globally accessible and meets both regulatory and security needs.

• "This integration provides sponsors with a robust solution for managing documentation throughout the entire clinical trial process, seamlessly working with the Medidata Clinical Cloud," said Glen de Vries, president, Medidata Solutions. "Establishing partnerships with a technology company like Veeva-one that is as dedicated to using the best of cloud computing to streamline and improve clinical trials-is crucial to ensuring the best possible offerings for our customers."

Vault eTMF is a cloud-based solution that provides clinical trial sponsors and contract research organizations (CROs) with real-time access to clinical documentation throughout the clinical trial process. Integrating Vault eTMF with Medidata's suite of solutions, including electronic data capture (EDC), clinical trial management system (CTMS) and risk-based monitoring, saves valuable IT implementation time and costs by eliminating the need for multiple integrations of eTMFs and clinical systems across a trial's processes. Additionally, the partnership will speed trial start-up, reduce compliance risk and provide better visibility into trial processes.

• "Partnering with Medidata gives us the opportunity to further help research sponsors lower their cost of clinical development and speed time to market," said Peter Gassner, president & CEO, Veeva. "Complete and accurate documentation is a crucial part of any trial, and being able to provide it across the entire trial process via the cloud is a huge benefit for the life science industry."