P1vital® ePRO Clinical
P1vital® ePRO Clinical improves compliance, data quality and performance monitoring in clinical trials measuring mental health outcomes.
P1vital® ePRO Clinical is an online system developed to prompt, curate, and securely store clinical study data, allowing collection of high quality data at the Investigator site and remotely. The flexibility of the system allows for collection of clinician-reported and participant self-reported data using both questionnaires and behavioural tasks. In clinical studies we have had positive feedback from users about its ease of use, resulting in excellent engagement and high levels of compliance both for researchers and participants with mental health conditions. The P1vital® ePRO Clinical has been developed and validated to meet all regulatory requirements and is in compliance with GCP and Medical Device legislation. Moreover, the systems and procedures relating to personal data collection, storage, protection, retention and destruction within the P1vital® ePRO Clinical are managed in accordance with the GDPR, and comply with applicable national legislation on data protection.
Within a clinical trial setting, P1vital® ePRO Clinical offers:
- availability in multiple languages
- accessibility to all across multiple platforms
- ease of integration into Phase 2a proof-of-concept trials through to Phase 4 post-marketing surveillance
- real time data capture with automatic data transmission upon questionnaire completion to optimise study timelines
- collection of high quality data at the Investigator site and remotely
- configurable feature set with flexibility to build and incorporate specific questionnaires and evidence-based tasks