News

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.

There is plenty of evidence and research which suggests that pharmacies are an excellent medium to engage clinical trial subjects.

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.

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

New adaptive study designs, new target diseases, and global studies require on-demand packaging and labeling methods in order to keep operating costs under control.

Quintiles and Biogen Idec have entered a five-year collaboration that is intended to increase clinical trial efficiency.

Quintiles and Biogen Idec have entered into a five-year strategic clinical development agreement.

This year the AACR conference was focused on "Harnessing Breakthroughs, Targeting Cures."

In December 2013, Sanofi opened its submissions for the second challenge in its Partners in Patient Health

Logi Analytics announced that eClinical Insights has embedded its Logi Info into its core applications