News

In my previous blog "From Science to Fiction" (ACTO, April 15, 2014), I discussed the trials and tribulations of unlearning the scientific writing style...

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As I was trying out a series of corrective lenses at an optometrist last week to choose the one that finally provided me the clarity that I was looking for, it made me pose a profound question to myself about perception and reality.

MedAvante, 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.

The 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.

According 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.

Drug development programs that involve several partners who share clinical development risks accounted for about half of all new therapeutic drug approvals in recent years and experienced longer clinical phase times, as well as longer overall time to approval, according to a study recently completed by the Tufts Center for the Study of Drug Development.

According 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.

DrugDev 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.

A 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.

A 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.