Patient, Caregiver, Site Rater, HCP & CRA Virtual Training
Training Topics
Roles and responsibilities, expectation setting and study overview
Minimizing placebo effect
Accuracy in reporting on PRO/ePRO, ClinRO/eClinRO, ObsRO/eObsRO and PerfO/ePerfO duration, severity and frequency including definitions and terminology
Importance of compliance with study tasks and procedures and medication/product adherence<\li>
“How-to” video-based tutorials for demonstrable procedures and tasks, such as using wearables, biosensors, DIY kits, collecting biological specimens and medication/product use
Study workflow and use of technology (i.e., devices, medical devices, software, mobile apps, systems integration)
Reporting on potential AE/SAE, concomitant and prohibited medications or products
Comprehension assessments, refresher training, remediation, reporting and trend analysis
Training is available 24/7
Virtual Informed Consent Training1.
What is informed consent?
Purpose
Potential Risks
Possible Benefits
1Providing participants with the information they need to make a fully informed decision
Participants who understand their role are more likely to complete study tasks
CENTRAL SCORING OF PATIENT DATA
Clinical experts rate image, audio and video files in a blinded manner for clinical trials, improving the quality of patient and caregiver reported outcomes
Technology enables PHI scrubbing and resolution/sizing for image capture
Reconciliation of primary and secondary rater scoring and concensus
Data monitoring and remediation
The Science of Pragmatic Health Innovation
Our integrated service model joins rigorous scientific analysis with pragmatic tech processes to more efficiently detect, progress, promote and implement new ideas in the life sciences and human health