NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions and data analytics for clinical research, today announced that the company has agreed to acquire Mytrus, Incorporated, an e-clinical technology company specializing in patient-centered electronic informed consent (eConsent) and virtual trials.
Medidata will integrate Enroll™, Mytrus’ eConsent solution, into the Medidata Clinical Cloud® as part of its ongoing commitment to modernize clinical trials for patients, sites and sponsors. With widespread support from international regulatory agencies, recent FDA guidance documents, industry groups like Transcelerate and large central IRBs, the clinical research and bio banking industries are rapidly adopting eConsent as a preferred alternative to paper. The addition of Enroll to Medidata’s industry-leading cloud platform will allow Medidata to comprehensively address the industry’s conversion to this new technology.
Specific benefits include:
- Educating patients about the clinical trial experience through the use of multimedia and interactive content to create a more efficient consent process
- Informing site investigators’ understanding of patient questions, facilitating meaningful dialogue with the patient
- Helping sponsors increase patient retention and compliance, enabling better remote tracking of consent and improved document management and version control
“The informed consent process is one of the most important parts of running both ethical and effective research projects. It's also the first step in giving patients a 21st Century experience, helping the critical elements of patient enrollment and retention in projects advancing healthcare," said Medidata’s president, Glen de Vries. “Adding eConsent to the Medidata platform reinforces our commitment to improving patient engagement by delivering better tools, more data and higher quality insights for patients and researchers.”
“Patients are the cornerstone of clinical research and they have the right to simple and convenient access to study information,” stated Mytrus CEO, Anthony Costello. “Our goal at Mytrus has always been to build technology that enables patients to be more connected to research. Together with Medidata, we will be able to quickly advance this mission and extend the reach of our products to more patients, on more studies, in more countries.”
Mytrus’ Enroll will become part of Medidata Patient Cloud®, a comprehensive and regulatory-compliant mHealth solution built to accelerate patient-centric clinical research. Patient Cloud’s current offerings include AppConnect, SensorLink and ePRO, which enable sponsors to collect subjective patient data through electronic clinical outcome assessments (eCOA) and patient-reported outcomes (ePRO) and objective data directly from patients using a variety of wearables and sensor technologies. The expanded Patient Cloud offering will now provide patients with a simplified, multimedia consent process, improving the patient experience from start to finish.
“eConsent is rapidly becoming a strategic capability within the clinical trial landscape. It makes trial participation easier and more intuitive for patients, and sets the foundation for more advanced analytics for sponsors,” said Marisa Co, Vice President, Business Insights and Analytics for Bristol-Myers Squibb Company. “Mytrus is a seamless fit within the Medidata Clinical Cloud, particularly with Medidata's patient engagement solution and mHealth offerings. We look forward to integrating this new unified capability to bring a more efficient consent process, reinforcing our continued efforts to improve the patient experience.”
It is anticipated that Medidata’s acquisition of Mytrus, Incorporated will be completed in April 2017, subject to customary closing conditions.
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Founded in 2009, Mytrus is a privately held e-clinical technology company specializing in patient-centered electronic informed consent and data collection tools. After receiving the first FDA approvals for remote electronic consent and virtual data collection, Mytrus has gone on to develop new technologies for patients including Enroll for eConsent, Engage for virtual studies and Enroll ID for biosample consent tracking and management. Mytrus also holds an exclusive patent for conducting virtual clinical trials in the U.S.
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 nearly 850 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 17 of the world's top 25 global pharmaceutical companies and is used by 16 of the top 20 medical device developers—from study design and planning through execution, management and reporting.
Certain statements made in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Medidata Solutions, Inc. (“Medidata”), including but not limited to statements about the expected closing of the acquisition and the effect of the acquisition. Such statements are based on management’s current expectations and are subject to a number of uncertainties and risks, which could cause actual results to differ materially from those described in the forward-looking statements. For additional disclosure regarding these and other risks faced by the Company, see disclosures contained in Medidata’s public filings with the Securities and Exchange Commission, including the “Risk Factors” section of Medidata’s Annual Report on Form 10-K for the year ended December 31, 2016. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and Medidata undertakes no obligation to update such statements as a result of new information.