News

This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 1 covers the addendums implications, objectives, requirements and advantages.

Faced with new EMA guidance on anonymizing clinical trial data, drug manufacturers have two choices – do what it takes to meet the November deadline and prioritize clinical study reports, or embrace a more sustainable strategy that starts with the patient-level data.

While launching a new clinical study is an exciting stage of product development for trial personnel, road blocks can emerge. A new approach is needed to cope with the volume of activates required for the study product registration.

The Society for Clinical Research Sites (SCRS) announces that Greenphire has joined its Global Impact Partner (GIP) program.

WCCT Global, an international clinical research organization, and Medelis Inc., an oncology clinical research organization announce a merger.

European forum tackles the problem of limited elderly patients involved in clinical trials.

Survey reveals mixed adoption of paperless data collection in clinical trials, pointing to the need for greater alignment of new eClinical technologies and study conduct.

CDER official comments on the significance of ICH's new alternative path for identifying the cardiac safety issue of QT prolongation in non-cardiac drugs.

Why electronic informed consent is key to supporting today’s patient-centric mantra in clinical trials.

Outlining those technologies best able to raise the data and process quality of risk-based monitoring.

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

If an FDA investigation results in a Form 483 then it is important to prove that earlier issues have been resolved upon re-inspection. The following steps using your Corrective and Preventive Action (CAPA) program are crucial to appropriately handling and responding to an FDA Form 483 in helping avoid a Warning Letter.

CRF Health announces reporting enhancements to its TrialManager platform for real-time analysis and management of data collected in clinical trials.

Quintiles announces its Precision Enrollment offering to accelerate site start-up and patient recruitment in oncology clinical trials.

ZRG Partners announce data for the first quarter of 2016 Global Life Sciences Hiring Index.

Pilot study evaluates the feasibility of using wearable devices in clinical data collection, including the training requirements for appropriate use of the mHealth technologies and the impact of the model on data quality and patient engagement.

Cenduit, a joint venture between Quintiles and Thermo Fisher Scientific, announced the release of its upgraded Patient Reminders tool.

Bioclinica releases OnPoint Direct, a Clinical Trial Management System geared toward mid-market biopharma and CROs.

Identifying Key Risk Indicators (KRIs) is an important step in successfully applying risk-based monitoring initiatives to a clinical trial. These factors, within risk management, assist by defining risk areas in order to measure and monitor them centrally throughout the trial.

Identity trust platforms assure clinical investigators that their credentials are legitimate by allowing use of a single identity that can be recognized across multiple entities. These platforms support collaboration by allowing drug development participants to access data, sign and exchange documents.