Parexel has teamed with tech subsidiary Perceptive Informatics on an Internet-based platform for the capture of safety and health-outcomes data in late-phase research. Parexel contributes trial expertise from its Peri Approval Clinical Excellence team while the Perceptive pitches in with its eClinical solutions for data capture, trial management, subject randomization and supply management, and electronic patient-reported outcomes.
The relations aim to help biopharma companies with data quality, decision-making, and the determination of evidence-based health outcomes. "We are focused on helping clients achieve greater efficiency by gathering more data at a significantly lower cost per patient," says Carol Collins, Parexel VP and head of the PACE team.
She maintains in an announcement that biotechs need to improve both their efficiency in data management and their control of spending in late-stage trials. Study data, she says, are now being used in the pharmacovigilance and health evaluation activities of regulators and payers. Platform capabilities cover Phase IIIb and IV clinical trials, observational studies, registries, expanded access programs, risk management programs, post-approval safety surveillance, and comparative effectiveness research.
The platform includes an interface with functionality for site self-registration and management; automated cues for late-phase compliance requirements; reporting capabilities that include such site-based features as investigator payment reports; and centralized access to data, including that for sites, patients and clinical supplies.
- read Parexel's release