News

Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.

Survey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.

Measuring clinically relevant response requires routine and regular collection of outcomes data.

Click the title above to open the Applied Clinical Trials February/March 2016 issue in an interactive PDF format.

French safety authority confirms what had been speculated--Phase I volunteers received the fifth of the highest dose escalation of the investigational drug at the same time, which goes against EMA recommendations.

Oracle will participate as a Global Impact Partner (GIP) and will participate on the SCRS Global Impact Board at an executive level, and work closely with SCRS’ Leadership Council to determine strategic initiatives for SCRS.

Bioclinica has built a post-approval study-specific technology platform along with a Program Coordinating Center (PCC) with dedicated and experienced post-approval research staff.

The alliance’s primary goal is to be flexible and adaptive based on client needs, while mitigating client risk, driving efficiency and improving timelines, and removing barriers that prevent getting treatments to market in a timely fashion.

A "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.

In addition to the patient education database, guidelines for the interaction of patient organizations with ethics, health technology assessment, regulatory bodies and industry are being developed with the goal of being released later in the year.

Gather™ is an integrated technology system that can be accessed through any internet-connected device and uses a module-based product suite.

New approaches include using Big Data to identify and understand patient populations, engaging the “voice of the patient” in trial design, and using new technologies and social media to reach, attract, and keep patients.

Clinerion will present its Patient Recruitment System (PRS), which allows real-time patient search for clinical trials via direct query of electronic health records.

FDA will provide expert scientific, clinical and statistical input to guide the further enhancement of CCDA to support FDA reviewers in rapidly detecting and investigating safety signals during new drug application (NDA) reviews and post-market pharmacovigilance activities.

The second phase of this global collaborative platform includes initial roll-out of a federated trust framework for secure enterprise-wide identity management and single sign-on access to multiple end-user applications.

Medidata's ClinicalCloud will provide scalable technology to Celltrion's biosimilars development programs.

The alliance will offer hybrid studies that combine existing data from electronic health records (EHRs) and medical claims (from Optum) with global, site-based clinical research (Parexel).