Medidata SCA Wins Scrip Award for Best Technological Development in Clinical Trials - Sponsor Focused

Medidata (NASDAQ:MDSO), the leading global provider of cloud-based technology and data analytics for clinical research, is pleased to announce that the Medidata Synthetic Control Arm (SCA) was recognized at the 2017 Scrip Awards as the "Best Technological Development in Clinical Trials - Sponsor Focused." Out of the 15 other award categories, 11 of the nominees are Medidata customers.

The first-of-its-kind scientific offering, Synthetic Control Arm (SCA), leverages Medidata Enterprise Data Store (MEDS) clinical data repository that includes thousands of oncology trials. It forms a control arm made up of patients with baseline disease and demographic characteristics that match the experimentally treated patients in a current-day single arm trial. SCA enables safety, efficacy and subgroup analyses of a single arm trial that are usual for a concurrently controlled trial.

"The Scrip Awards judges selected the Medidata Synthetic Control Arm as the best sponsor-focused technological development in clinical trials because eliminating an entire control arm of a trial with a powerful improvement to historical controls is truly innovative, offering both cost and time savings as well as reducing the burden on their entire clinical trial ecosystem,” noted Mike Ward, global head of content for Informa Pharma Insights portfolio.

Presented to Medidata at the 13th Annual Scrip Awards on November 29, 2017 in London, the award celebrates excellence and innovation in the biopharmaceutical industry and a continued commitment to improving healthcare on a global scale. A panel of judges—comprised of independent, senior industry experts from around the world—evaluated a record number of submissions across a wide range of categories, announcing a shortlist of finalists earlier this year. The Scrip Awards are managed by Scrip Intelligence, the premier source of information for the pharmaceutical industry.

"We are delighted to see that the Roche and Medidata collaboration on Synthetic Control Arm Development received the Scrip Award. These data, which were presented at the 2017 ASCO annual meeting, share our commitment to our scientists and research partners to help advance our oncology disease area understandings,” said Somnath Sarkar, PhD, senior director and therapeutic area global head for hematology-oncology and pRED oncology biostatistics at Roche.

"SCA utilizes patient-level historical clinical trial data to enhance the interpretation of single arm trials, making predictions about the treatment effect sizes of experimental products likely to be observed in confirmatory concurrently controlled trials long before they are conducted,” said David Lee, chief data officer, Medidata. "With the Medidata Synthetic Control Arm, we have enabled our clients’ important go/no-go decisions to be made with more accuracy and certainty, which translates into improved ROI for their R&D investments.”

About Medidata

Medidata is reinventing global drug and medical device development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including over 950 global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.

The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting.

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