News

Two leading drug development and regulatory consultancies announced they have formed a new strategic alliance to help life science companies navigate an increasingly complex global environment.

Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority

Some can't miss sessions for the upcoming meeting.

Study Connect™ App Enables the Mobile Management of Randomization, Inventory Management and Unblinding in Clinical Trials

ERT, a provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, announced the availability of a new solution to wirelessly integrate ECG data collection with an electronic Clinical Outcome Assessments (eCOA) tablet.

Merck & Co. Chief Medical Officer Dr. Michael Rosenblatt speaks with Applied Clinical Trials about the significant opportunities and challenges of sharing clinical trial data and the progress so far in developing a framework that, if properly pursued, could help transform the future of research and clinical care.

Certara®, a global biosimulation technology-enabled drug development consultancy, announced that it is endowing a new three-year, full-time position – the Certara Lecturer in Precision Dosing – at the Manchester Pharmacy School, The University of Manchester, England.

Agency concerned about how proposals in "Cures" bill will be crafted and implemented.

IAOCR, a provider of independently recognized, competence-based accreditation, consultancy and accredited training for clinical research professionals, offered comment the new EU regulation for clinical trials planned for implementation May 28, 2016.

Study finds that almost 75% of cancer drug candidates rely on biomarker data. 

How the application of evolving M&S models are transforming full-research design strategies.

Regulatory: Solving Generic Cliff with 505(b)(2) The U.S. Biosimilar Pathway Trial Design: Modeling & Simulation Strategies Lifecycle Management: Bridging Economic & Clinical Value Also in this issue: EMA's Dueling Tones on Regulatory Vision Regulatory Compliance: The Site Burden Assessing Safety for Follow-on NBCDs

This latest, updated eBook on Risk-Based Monitoring from Applied Clinical Trials, includes the latest information on the topic being discussed around clinical trials.

Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the European Medicines Agency.

eClinical technology services provider Clinerion and the Alliance for Clinical Research Excellence and Safety (ACRES) announced their partnership for accelerating patient recruitment and promoting risk-based quality management.

The DIA has an app to help navigate meetings from your smart device, and has been updated this year.

TrialScope, a provider of clinical trial transparency and compliance solutions, announced a clinical trial sponsor has selected its PharmaCM clinical trial disclosure platform.

The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.

 Engaging and recruiting participants for clinical trials continues to be a struggle for the life sciences industry. However, emerging technology partnerships in the biopharma space may be providing hope in accelerating patient enrollment and reducing bottlenecks through a concentrated focus on target profiles.