News

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.

Run or walk with CISCRP to raise awareness of volunteers who give the gift of their participation in clinical research and make new medical discoveries possible.

PAREXEL announced enhancements to its Randomization and Trial Supply Management (RTSM) service.

Recently, Applied Clinical Trials formed a Project Manager Committee, whose members will advise us on matters important for them to succeed in their positions

An increasing amount of public data on clinical trial research has become available, including ClinicalTrials.gov and Open Payments.

The manipulation of data from studies conducted in India have led the European Medicines Agency (EMA) to confirm suspensions of a number of medicines.

With the DIA housing program, there is such a thing as a free breakfast at select DIA Hotels.

PRC Clinical, a CRO specializing in clinical trial management, is joining the Alliance for Regenerative Medicine (ARM).

This whitepaper discusses the importance of observational research and patient registries in evidence generation. The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs sub-serving different objectives … Increasingly central is the inclusion of observational studies, including registries, which provide insights missing from traditional nterventional studies encountered in the course of drug development.

Eisai announced that, in order to further promote transparency in clinical trial data disclosure, it has determined its policy on clinical trial data disclosure and is making clinical trial data publicly available to researchers via an external website.

BioClinica®, Inc., a specialty clinical trials services and technology provider, has partnered with advisory and outsourcing services company Kinapse on BioClinica’s Compass Intelligent Monitoring solution.