Improving compliance, data quality and performance monitoring in clinical trials measuring mental health outcomes.
The P1vital® ePRO system is an online system developed to prompt, curate, and securely store clinical study data, allowing for collection of high quality and high integrity data.
The system is specifically designed to be user friendly both to researchers and patients with mental health conditions, encouraging good engagement and high compliance.
The flexibility of the system allows for collection of clinician-reported and patient self-reported data using both questionnaires and behavioural tasks.
Within a pharmaceutical trial setting, the P1vital® ePRO system offers:
- accessibility to all across multiple platforms
- ease of integration into Phase 2a proof-of-concept trials through to Phase 4 post-marketing surveillance
- data capture in real time to optimise study timelines
- flexibility to build and incorporate specific questionnaires and evidence-based tasks (including the P1vital® PReDicT Test) tailored to company need
The P1vital® ePRO system 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 are managed in accordance with the Data Protection Directive 95/46/EC, and comply with applicable national legislation on data protection.