News

Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator.

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has today announced several expanded capabilities within its European Clinical Supply Services network.

The Randomized Clinical Trial (RCT) is considered the gold standard of research and adds credibility to the efficacy or effectiveness of an investigational new drug. However, with a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding. This eBook examines the growing trends of evidence gathering and how that impacts the clinical trials industry.

ERT, a leading global solution provider for high- quality patient safety and efficacy endpoint data collection, and PHT Corporation (PHT), the eClinical innovator leading the adoption of patient-driven mobile apps for improved clinical research, announced today that they have signed a definitive agreement under which ERT will acquire PHT.

It seems only yesterday that the future for European pharma was personalized medicine. The European Union first gave the term official status in a formal paper in 2008, entitled a Renewed Vision for the Pharmaceutical Sector, in which the Commission included a section on ‘Towards more personalized medicines’.

The current regulatory environment of a particular country plays an important role in the geographic selection. For India, it is very relevant because of problems in clinical trials approval and conduct issues during last few years.

A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.

The Alliance for Clinical Research Excellence and Safety (ACRES) announced the launch of ACRES BlueCloud™

TransCelerate BioPharma Inc. has selected DrugDev to develop and host its Investigator Registry

One of the primal questions clinical trialists engaged in clinical research and development always face is do we “keep or kill” a drug based on the data in hand.

The deal will enable Synexus to further expand both its global network of clinical research centers - into the US, Asia and South America - and the range of therapy areas it focuses on.

The deal will enable Synexus to further expand both its global network of clinical research centers - into the US, Asia and South America - and the range of therapy areas it focuses on.

Global network accelerates patient recruitment and clinical trial start-up times

IntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.

Part 1 of 7

Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

CRF Health, a global provider of electronic Clinical Outcome Assessment solutions for the life sciences industry, announced a new partnership with Vodafone.

Theorem Clinical Research, a prominent global contract research organization, and Biomedical Systems, a leading provider of comprehensive centralized diagnostic services, have formed a strategic partnership

Part 2 of 5

PHT next week will announce a new suite of clinical research patient engagement apps at the Summit for Clinical Ops Executives conference in Orlando