Convergence between EDC and RTSM solutions simplifies workflow management

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), today introduced unique product convergence between its DataLabs® EDC solution and ClinPhone® Randomization and Trial Supply Management (RTSM) technologies.

New functionality in the DataLabs EDC solution has created advanced interoperability with the ClinPhone RTSM technologies, allowing the use of either system for randomizing patients and dispensing medication.

"In order to further simplify workflow and enable users to perform activities using whichever system is best suited to their preferences, we are continuing to blur the boundaries between our EDC and RTSM solutions," said Bill Byrom, Ph.D., Senior Director, Product Strategy, Perceptive Informatics. "Fueled by the next version of Perceptive's EDC solution, this latest achievement in true convergence represents a radical shift in the way technologies can be used together to accelerate clinical trials."

The convergence between the EDC and RTSM solutions in Perceptive's eClinical Suite significantly simplifies workflow, making it easy for clinical site personnel to use both technology solutions seamlessly within a single clinical trial. The DataLabs EDC system can be used as an interface to the ClinPhone RTSM technologies so that clinical sites can randomize and dispense medication in real time. Users can perform these activities without logging into a second system, eliminating the need to enter data via phone or online, then reconcile within the EDC system at a later time. This approach increases efficiency and productivity for sponsors and sites, and ultimately reduces the costs associated with clinical research.

Key features of the greater convergence available in Perceptive's EDC-RTSM solutions include:

• Patient Randomization - Enables sites to randomize a patient from the DataLabs EDC system, an advanced capability not available in typical stand alone EDC systems
• Medication dispensing - Sites can request dispensation of medication or devices for patients as needed, directly from the EDC system, without logging into a second system
• Request Replacement - Sites can request a replacement for a previously assigned medication or device in the case of damage, loss, or other reason

The DataLabs system, a leading EDC solution from Perceptive Informatics with a user-friendly interface, is suitable for all types and sizes of clinical trials. In addition to the tight interoperability with RTSM functionality, DataLabs provides a single electronic clinical data management platform to unify the functionality of paper data entry (PDE) with the flexibility of EDC. The hybrid capability enables studies to include sites using paper CRFs and support existing paper processes such as collection of extraneous paper data, providing sponsors with the ability to choose their preferred method of data collection.