Regulators and payers are increasingly requesting long-term safety and health outcomes data and this is driving growth in post-approval studies. In turn, this has created a need for new technology platforms.
“A variety of late phase studies, including observational studies and patient registries, are being used as either primary or adjunct vehicles for pharmacovigilance and health evaluation activities”, explained Carol Collins, corporate vice president and worldwide head of PACE at Parexel.
To manage the increased data throughput volumes resulting from the growth in post-approval studies, while keeping costs down, Parexel has adopted a new web-based technology platform.
The system integrates strategies and processes developed by Parexel’s PACE (peri approval clinical excellence) team and eClinical technology from Perceptive Informatics, a subsidiary of the contract research organisation (CRO).
Adoption of the system allows Parexel to produce higher quality data at a significantly lower cost per patient. Furthermore, tools such as electronic data capture (EDC) and electronic patient reported outcomes (ePRO) work in conjunction with the system to improve data integration.
Parexel added that randomisation and trial supply management (RTSM) and clinical trial management systems (CTMS) can also be incorporated into the post-approval platform.
The system provides centralised access to data, including site, patient and clinical supply information. Additional features include enhanced reporting capabilities, automated cues for unique late phase site requirements and functionality for site self-registration and management.