New York, New York - - Medidata, a Dassault Systemes company, today launched myMedidata Registries, a new technology that expands and strengthens the myMedidata patient portal to engage patients before and after (i.e., long term follow up/safety surveillance) a clinical trial. This empowers patients to learn more about clinical trial opportunities and provides an experience that allows for active participation throughout their clinical trial journey. With increasing interest and adoption of decentralized clinical trials, myMedidata Registries gives patients continuous support in and out of a trial with access to one portal for all of their research needs - providing an everlasting engagement on one portal for life.

Issues surrounding patient awareness of and access to clinical trials have been roadblocks to participation for many years. According to the Center for Information and Study on Clinical Research Participation (CISCRP), only 25 percent of individuals reported being "very confident" in their ability to find a clinical research study.1 Furthermore, 98 percent of individuals surveyed were willing to participate in another study, yet many reported they never heard back from anyone after the study was completed, be it clinical trial results, patient data return, a thank you note, or an invitation to a new study.2 These individuals are never engaged and the traditional recruitment cycle starts anew with each upcoming trial.

"The time for myMedidata Registries is now," said Anne Marie Mercurio, a distinguished patient advocate and caregiver, and a member of Medidata's Patient Insights team. "The patient community needs a quick, easy, secure way to get engaged with clinical research. My message is: Don't miss out - the more who join, the faster we can get the scientific evidence to better understand and treat diseases."

Built directly on the Medidata Clinical Cloud, the only unified technology platform dedicated to clinical research, myMedidata Registries provides education, pre-screening, patient data collection, and opportunities for video visits before a patient travels to a site or is enrolled into a study. Clinical trial sponsors and CROs using myMedidata Registries have a direct, secure connection with trial participants via notifications and alerts, allowing them to optimize trial participation, and increase product and trial awareness.

"myMedidata Registries is designed to transform patients' clinical trial experiences from being a transactional and impersonal process to a seamless and engaging one that deepens relationships between participants, sponsors, and trial sites," said Kelly McKee, Vice President, Patient Registries and Recruitment at Medidata. "This redefines Medidata's end-to-end technology solutions and represents a major advance for the life science industry, providing patients with a new option to pursue care." See how the registry works by clicking here.

myMedidata Registries - first introduced in the US and with other countries to follow - provides sponsors with one, unified ecosystem for patient identification, study execution and end-of-study patient communications, including patient data return. Once a new therapeutic, vaccine or medical device is on the market, myMedidata Registries allows sponsors and CROs to continue to engage with participants when long term follow up (LTFU) and safety monitoring is required. Regulators require LTFU for thousands of studies, with human gene therapies needing 15 to 30 years or more. Additionally, myMedidata Registries can be used to bridge patients moving from Phase 2/3 to Phase 4 clinical trials.

Medidata Patient Insights and Patient Centricity by Design

myMedidata Registries was designed for patients by patients, in partnership with Medidata's Patient Insights team. Medidata's team of dedicated patient advocates uses the Patient Centricity by Design (PCbD) process that infuses the patient perspective into the software development life cycle to create technical solutions that improve the overall patient experience in clinical research interactions. The PCbD initiative was named the first-place winner at the 2021 SCOPE Participant Engagement Awards.

The myMedidata Patient Portal

myMedidata is a web-based, single-destination patient portal,encompassing all of the capabilities of Medidata's patient-facing solutions for electronic consent and clinical outcomes assessment (eCOA) along with live video investigator/patient visits using myMedidata LIVE all through one web-based intuitive interface. With myMedidata, patients can use any online device to virtually learn, enroll and participate in clinical trial activities. With more than 20 years of innovation, Medidata offers a streamlined and trusted approach to decentralized clinical trials.

Medidata is a wholly owned subsidiary of Dassault Systemes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

https://www.ciscrp.org/education-center/charts-statistics/

https://www.ciscrp.org/wp-content/uploads/2019/12/Participation-Experiences-04DEC-1.pdf

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