News

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.

While at the 2014 Bio IT World conference, I had the opportunity to interview Pek Lum, Ayasdi's Chief Data Scientist.

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.

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.

Medical "Oscars" celebrate excellence in healthcare across the UK

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.

A 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 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.

DrugDev, the industry?s largest global network of active clinical trial doctors, today announced its acquisition of TrialNetworks.

Quintiles-led guide from AHRQ addresses registries, patient outcomes, and updates the late phase research initiatives.

Quintiles' Real-World & Late Phase Research division leads AHRQ effort for evaluating patient outcomes since 2005.

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.

The Pfizer-AstraZeneca courtship raises many fascinating questions about the future shape of the international pharmaceutical industry, but it is also revealing some remarkable displays of parochialism.

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.

Product will serve as a data source for D360, supporting ongoing study monitoring and cross-study analyses

Medidata

Target Health and Life-On-Key have started the second year of a 2-year project grant.

The advent of Risk Based Monitoring will change the traditional Clinical Study Monitor’s (Monitor) role significantly.

Certara, a global technology-enabled drug development and drug safety consultancy, has launched its Pre-clinical Safety Store

Medidata Solutions announced that Sanofi has selected Medidata's targeted source document verification solution

NextDocs announced that leading pharmaceutical and biologics companies implemented late last year the NextDocs clinical solution suite

Groundbreaking site benchmarking data proves that sites with more staff certified are more profitable than those with fewer staff certified.

As of the April 2014 issue, the award-winning journal formerly known as The Monitor has been redesigned, rebranded, and reborn...

The ACRP announced it has changed the name of its official association journal

Top Pharma Increases Adoption of Medidata's Technology to Support Significant Operational Efficiencies Across Global R&D Organization

Company Integrates eTMF, CTMS and Investigator Portal to Bring Together Essential Clinical Trial Constituencies onto One Management System