news roundup

European CRO Chooses TrialMaster EDC

OmniComm Systems announced that a European CRO will use its TrialMaster EDC to complement an existing in-house EDC.

Updated CRF Bracket Solution Supports Remote Consent

CRF Bracket announced a new release of TrialConsent eConsent solution, with enhanced capabilities to support remote consenting in virtual clinical trials, which includes remote consenting and at-home consenting by patients.

WCG Solutions Targets Institutions, Independent Sites

WIRB-Copernicus Group introduces WCG SiteReady, a comprehensive, end-to-end solution for institutions and independent sites. WCG SiteReady addresses the issues of regulatory compliance, contract and budget negotiation, study start-up, and patient enrollment in clinical trials.

Articles

FDA Clarifies Cell and Gene Therapy Policies

FDA anticipates that sponsors and researchers will file more than 200 investigational new drug applications (INDs) for cell and gene therapy products by 2020, adding to the more than 800 applications currently on file for cell-based or directly administered gene therapy applications. To that end, it plans to add 50 reviewers to its expert staff in CBER, as well as more FDA guidance documents to clarify policies and further advance innovation in this area.

EMA, EU Addresses Big Data Challenges

A mid-February report from the EMA and the heads of more than a dozen of Europe's national agencies, outlines their views on how to respond to the proliferation of threats and opportunities from big data.

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Lisa Henderson
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LHenderson@mmhgroup.com