News

The developed markets of North America and Europe together saw approximately 81% of the Phase I trial share in 2013 which is a 6% increase from 2012. Trials

The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials.

The idea is great: when an investigator submits a grant to any NIH institute, if the study will involve more that one performance site, the grant must include a plan to rely on one single IRB.

One way to reduce off-label prescribing of treatments for cancer and other conditions is for manufacturers to test additional indications and file supplemental applications to add those uses to approved labeling

TransCelerate BioPharma announced two new members, Merck & Co. Inc., and Novo Nordisk.

TransCelerate BioPharma Inc. today announced two new members, Merck & Co. Inc., and Novo Nordisk, to the biopharmaceutical non-profit organization.

ArisGlobal, a leading provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agencys EudraCT database

ArisGlobal, a leading provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agencys EudraCT database

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA). Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.

Improves data quality and regulatory compliance by combining scientific training with innovative electronic implementation of instruments

The pharmaceutical industry is further optimizing the collection of high quality electronic patient reported outcomes (ePROs) data for clinical research, with PHT Corporation Rater Training programs

Over the past few years, the number of active, accredited Ethics Committees (EC) in the Netherlands has dropped at a steady pace. The decline over the past year has partly been due to the merger of several ECs.

The European Medicines Agency (EMA) has launched the public consultation on how the transparency rules of the European clinical trial regulation will be applied in the new database.

To improve visibility, control, and collaboration for its ongoing and planned clinical trials, San Diego-based biotech Conatus Pharmaceuticals selected Veeva Vault eTMF and Veeva Vault QualityDocs – cloud applications for the management of clinical study and quality and development documentation, respectively

Instinctively, when there are more investigators/sites being deployed for a trial with a defined number of patients needed, we should expect shortened enrollment cycle time. This sounds right, but is it really?

Efforts are escalating to encourage sponsors, research institutions and clinical investigators to accept oversight for multi-center studies by central Institutional Review Boards (IRBs).

The need for innovation in clinical trials has sparked significant interest from a variety of new enterprises including technology, analytics, subject enrollment/engagement/retention, EDC, risk-based monitoring, and many mor

Pharmaceutical Product Development, LLC (PPD) has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility.

Analytical testing facility adds state-of-the-art cell-based lab capabilities

Clinical Conductor, the industry’s most collaborative CTMS, was recently fitted with new features and functionality that provide users with even more capability to connect with other research technologies and further collaborate with research partners to ensure clinical research success.

With the US Food and Drug Administration (FDA) approving an all-time record number of orphan drugs during 2014, the pricing of these treatments is set to come under increased scrutiny.

Research and consulting firm GlobalData says the FDA approved an all-time record number of 17 orphan drugs during 2014

Covance has introduced its Early Phase Development Solutions, a multi-disciplined approach to early drug development.

Covance Inc., the world’s most comprehensive drug development company, today announced the introduction of Covance Early Phase Development Solutions,

eClinical Solutions, LLC, a leading provider of data management services and technologies, today announced the release of elluminate®.