Category Archives: Medidata Solutions

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

Veeva Systems has partnered with Medidata Solutions 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.

Medidata Solutions to Show New Clinical Cloud Products, Enhancements at DIA

English: Medidata Solutions Logo

Medidata Solutions will showcase new products and features that broaden its clinical cloud platform at the upcoming Drug Information Association’s (DIA) Annual Meeting, June 24-28 in Philadelphia, Pa. Addressing new industry regulations, the need for broad safety reporting and improvements to site monitoring processes, these enhancements to Medidata’s comprehensive solutions will offer drug developers new capabilities for overcoming key research challenges.

“Sponsors are under more pressure than ever to cut costs, improve efficiency and adhere to increased regulations, requiring innovation and real-time operational analytics across the clinical research chain from concept to conclusion,” said Glen de Vries, president of Medidata Solutions. “We are continuously broadening our solution set to empower sponsors to improve their research clinical systems at every point in the clinical process, including trial planning, monitoring, site payments and safety.”

From booth #3101, Medidata will be providing demos of key products and new features to enable sponsors to achieve key goals, including:

  • Driving a New Monitoring Paradigm
    The company’s first
    solution for managing site quality and the latest addition to the
    Medidata Insights™ family of clinical business analytics offerings, Medidata
    Insights SQM™ combines advanced data visualization with seamless
    real-time data availability with the rest of Medidata’s platform to
    deliver turnkey site quality management – further enabling the
    industry’s shift to simplified remote monitoring of site and data
    quality resulting from the 2011 FDA clarification on source document
    verification (SDV).
  • Automating Safety Processes with Electronic Adverse Event Transfer
    help drug developers meet post-marketing expedited reporting
    obligations within the new European pharmacovigilance legislation, Medidata
    Rave Safety Gateway™ expanded its capabilities for sites to
    electronically transfer non-serious safety case data – in addition to
    serious safety case data – to sponsors’ safety systems, eliminating
    paper-based manual processes, reducing query cycles between sites and
    sponsors’ safety groups and minimizing reconciliation between safety
    and clinical databases.
  • Ensuring Timely Investigator Payments
    Due to the
    complexity of triggering investigator payments from sponsor-set
    milestones, site payments are often delayed. The out-of-the box
    integration of Medidata
    CTMS™ and Medidata
    Rave® electronic data capture (EDC) improves the
    efficiency of clinical operations, streamlining workflows in areas
    such as site monitoring and site payments. Now, Medidata Rave EDC data
    is pulled into Medidata CTMS™ monitor reports, increasing the accuracy
    of reporting and timeliness of payment triggers.
  • Assuring Market Value Compliance and Faster Budget Agreements
    for sponsors receiving investigator-sponsored proposals from sites, Medidata
    Grants Manager Investigator Initiated™ offers drug developers
    clarity and uniformity in judging pricing and conduct of their
    submitted funding requests.
  • Ensuring the Right Randomization Approach to Meet Study GoalsMedidata
    Balance™ now provides the block randomization methodology in
    addition to dynamic allocation randomization, extending its use to new
    segments of the life science industry by permitting researchers to use
    the approach that best suits their study goals.