FDA inspections continue to highlight recurring issues with site performance throughout the past ten years. To prevent performance issues, sites rely on actionable performance information prior to preparing for regulatory inspection. According to a Society of Clinical Research Sites (SCRS) white paper survey:
- 71% of sites confirmed they prefer knowing how they are performing, so they can make adjustments and improve
- 79% of sites reported a desire to receive a study dashboard
- 85% of investigators find benchmarks and metrics extremely valuable
In response to this clear and demonstrated need, Medidata (NASDAQ: MDSO) created Study Site Analytics which provides sites with access to standardized performance metrics from sponsors and CROs. The feedback includes metrics for screen failure, early termination, and enrollment. For each metric, Study Site Analytics also provides benchmarks for sites to compare their performance relative to other anonymized sites within a study.
“The SCRS survey emphasizes the overwhelming need for insight into performance metrics and how the industry can and should work together to make the right process improvements,” said Glen de Vries, co-founder, president, Medidata. “I’m proud to say we’ve delivered a feature that brings key indicators for sites to the front page of their iMedidata dashboards, and enable better collaboration with sponsors, ultimately bringing therapies to patients faster.”
Insights alongside performance comparisons enable sites to pinpoint where they are over/under performing. This information allows sites to make informed decisions that improve specific processes and procedures as well as share performance with sponsors for future studies.
“Sites have been requesting access to the important data contained within Medidata’s Site Analytics Dashboard for several years,” said Casey Orvin, SCRS president. “Years ago, SCRS founder Christine Pierre challenged the Medidata team to create a means to give sites access to benchmarking data on how its site stacks up against others on a given trial. Medidata has met that challenge with the Study Site Analytics Dashboard. With the shift toward digitally powered clinical trials, visibility into this data has never been more important to all parties involved.”
Medidata will attend the SCRS 2019 Global Site Solutions Summit, October 11 – 13, in Hollywood, Fla. Presenters will include:
Jackie Kent, SVP, head of product: The SCRS Diversity Project: A Global Perspective in Enrolling Diverse Populations, Oct. 11, 5:25 – 6:00 p.m.
- Anthony Costello, VP, mHealth: Partnership Driven Innovations: How Industry is Partnering to Reduce Site and Patient Burdens, Oct. 12, 11:00 – 11:40 a.m.
Medidata is leading the digital transformation of life sciences, with the world’s most-used platform for clinical development, commercial, and real-world data. Powered by artificial intelligence and delivered by industry experts, Medidata helps pharmaceutical, biotech, medical device companies, and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata and its companies, Acorn AI and SHYFT, serve more than 1,300 customers and partners worldwide and empower more than 150,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.medidata.com