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 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
To
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
Designed
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.
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