A recent survey found that sponsors do not have the required metrics to properly assess their operational activities related to drug safety reporting. Applying capture technology is one way to better measure these processes and ensure consistent data quality for medical evaluation.
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.
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