Good Clinical Practice (GCP)

See the following -

OpenClinica – A Leading Innovative Open Source Clinical Trials Solution

One of the top choices of Open Health News (OHNews) readers looking for information on 'open source' eHealth solutions in 2012 was Ophttp://www.openhealthnews.com/content/openclinicaenClinica.  OpenClinica has positioned itself as one of the world's leading open source clinical trials software for electronic data capture (EDC) and clinical data management (CDM).  OpenClinica was first released in 2005. OpenClinica has been successfully used in thousands of clinical trials across some very diverse settings in over 100 countries. It has been used in studies involving 10 to 100,000 patients and in dozens of regulatory submissions for all phases of clinical trials. The OpenClinica Community now consists of over 15,000 members world-wide. Read More »

TransCelerate BioPharma Inc. Publishes Risk-Based Monitoring Recommendations For Central Monitoring And Technology Considerations

Press Release | TransCelerate BioPharma Inc. | September 17, 2014

TransCelerate BioPharma Inc. ("TransCelerate") announced today the publication of its two most recent manuscripts on risk-based site monitoring ("Risk-Based Monitoring" or "RBM"), developed jointly by its 19 member companies. Both manuscripts have been accepted and published through the Drug Information Association's Therapeutic Innovation & Regulatory Science journal...

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