This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 2 covers steps that organizations can take today to begin adopting a centralized technology-based approach to risk management.
Outlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.
Patient recruitment remains a challenge for both the biopharma industry and the oncology research community. New recruiting platforms in development have the potential to change the way the industry uses technology, data and the internet to augment recruiting efforts.
This article examines the requirements for developing an effective Clinical Trial Protocol, observing that it takes time, commitment, and a full team effort to produce protocols of an acceptable standard.
Survey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
ICON plc announces the results of research evaluating patient-centric and patient-designed informed consent formats from Carnegie Mellon University.
Generic drug repurposing can often create medical solutions regardless of the supporting entity. “Unsolved” diseases can benefit from this strategy despite commercialization challenges.
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.
Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.
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.
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