Is eConsent adoption poised to grow?

Friday, September 1, 2017

Activity in the eConsent sector has risen considerably during the past six months, with Medidata’s acquisition of electronic informed consent pioneer Mytrus and the entry of new market players, even though widespread industry adoption of the technology has appeared to have stalled.

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inVentiv, Medidata partner to expand use of patient-centered technology

Wednesday, June 28, 2017

Medidata, a global provider of cloud-based technology and data analytics for clinical research, and inVentiv Health, a biopharmaceutical professional services company,  announced a multi-year partnership to bring patient-centric technology and leading clinical trial expertise to the biopharmaceutical industry. The partnership will broaden the reach of Medidata’s electronic informed consent (eConsent) technology, Medidata Enroll, to patients, sites and biopharmaceutical clients worldwide.

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Medidata to acquire Mytrus

Tuesday, April 18, 2017

Medidata, a global provider of cloud-based solutions and data analytics for clinical research, has agreed to acquire Mytrus, an eClinical technology company specializing in patient-centered electronic informed consent (eConsent) and virtual trials.

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OHRP/FDA offer final guidance on electronic informed consent

Saturday, April 1, 2017

On December 15, 2016, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) and the FDA published final guidance aimed at providing answers to commonly asked questions about using electronic informed consent (eConsent)in clinical investigations. The guidance applies to “electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.

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Britain’s NHS approves Mytrus e-informed consent

Wednesday, September 9, 2015

Mytrus, a technology and services company working in clinical trials, has announced its software platform for electronic informed consent has received approval for use by Britain’s National Health Service (NHS). It is the first time e-Consent technology will be used in a trial in England.

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U.K. approves informed consent technology

Tuesday, September 8, 2015

With a goal of pushing aside paper-based informed clinical trial consents and providing an electronic informed consent system, California-based Mytrus and an unnamed Top 10 pharmaceutical company are set to become the first organizations cleared to use eConsent technology in the U.K.

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