TransCelerate's Quality Management System (QMS) Initiative delineates specific mechanics that will be used to build a QMS Conceptual Framework to facilitate and encourage proactive approaches towards executing Good Clinical Practices, and proper change management expected to support a culture of quality.
The companies believe the CluePoints' Central Statistical Monitoring (CSM) solution that uses statistical methodology to identify unusual patterns in clinical trial databases, will help detect potential data quality problems in CNS trials.
A snapshot of one novel approach in RBM implementation and the data and site performance lessons learned.
Democratic candidate Hillary Clinton is introducing her Prescription Drug Plan which is meant to benefit patients, however, will Hillary’s plan be good for advancing novel therapies, and will it benefit R&D organizations?
Addressing the challenges unique to purely industry-sponsored trials is explored.
The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place.
Rasi was forced to step down in November 2014 by the EU Civil Service Tribunal after a panel of experts found the European Commission (EC) had used improper procedures when it had selected him back in 2011.
Aligning patient-centric approaches with personalized medicine and biomarker use is transforming the design of Alzheimer's trials.
A review of public data indicates a small increase in Phase III inclusion/exclusion criteria per trial over a five-year period.
This experimental technique is being studied to see whether it could treat certain health problems.
Examining the practical significance of reporting patient deaths due to main disease progression.
Using a specific trial, the importance of assessing the success of therapy masking is examined.
Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.
Trial Design: Gene Transfer: Key Challenges Therapy Masking Assessment Safety Reporting: Death Waivers Fall Short Subject Engagement: Phase I Satisfaction Scores Also in this issue: Informed Consent Changes in Works Europe's Embrace of New Science Alzheimer's and Patient Safety
As the use of PRO expands in clinical trials, ePRO vendors themselveshave expanded beyond this constrained definition. Increasingly, the use of eCOA is being used to encompass all data collected related to the patient, which includes PRO, clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO). Further, with mobile health technology use growing in general healthcare, that use is changing outcomes data collection in clinical trials. This e-Book tackles the changing world of PRO collection in clinical trials.