MedAvante Introduces VIRGIL? Investigative Study Platform
May 8th 2014MedAvante, Inc., the world's leading provider of centralized assessments and quality control in clinical trials of treatments for central nervous system (CNS) disorders, announced the Virgil Investigative Study Platform for use by drug developers and their global cohort of trial sites.
ACRP to Celebrate Clinical Trials Day May 20
May 8th 2014The Association of Clinical Research Professionals (ACRP) is officially partnering with the European Clinical Research Infrastructures Network (ECRIN) in honoring the extraordinary contributions of clinical researchers worldwide on International Clinical Trials? Day--May 20. ECRIN launched the day in 2006 for organizations, clinical research professionals, and the public to acknowledge the life changing achievements that result from the work performed by clinical researchers.
ACRP To Celebrate International Clinical Trials' Day By Recognizing Clinical Research Professionals
May 8th 2014The Association of Clinical Research Professionals (ACRP) is officially partnering with the European Clinical Research Infrastructures Network (ECRIN) in honoring the extraordinary contributions of clinical researchers worldwide on International Clinical Trials? Day.
Risk-Sharing Lengthen Drug Development Timelines
May 8th 2014According to the study, mean clinical phase time was 8.9 months longer for new drugs in multi-firm, risk-sharing clinical development relationships, and total (clinical plus regulatory review) phase time was 9.5 months longer, compared to new drugs that did not involve these relationships.
Imaging Endpoints Uses AG Mednet Software to Reduce Queries
May 8th 2014According to industry research, more than half of all image-related clinical trial query stoppages result from preventable human errors that can delay a trial for up to seven weeks. AG Mednet's Submission Quality and Compliance software detects errors that result in query stoppages.
Compassionate Use Requests Complicate Drug Development
May 7th 2014A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval.
DrugDev Acquires TrialNetworks
May 5th 2014DrugDev announced it has acquired TrialNetworks, which offers a unified suite of integrated study management apps and site-facing tools called the Clinical Trial Optimization System. And not unlike its first acquisition of CFS Clinical in October 2013, the acquisition has elements of innovation, scale, and overall industry improvement as its impetus.
CHMP Recommended Marketing Authorization for 81 Medicines in 2013
May 1st 2014A total of 81 medicines for human use were recommended for?marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), compared with 57 in 2012, according to EMA?s 2013 annual report.
CHMP Recommended Marketing Authorization for 81 Medicines in 2013
May 1st 2014A total of 81 medicines for human use were recommended for?marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), compared with 57 in 2012, according to EMA?s 2013 annual report.