Perceptive, XClinical debut study-design automation tools

This week's DIA show is also the launching pad for two products that can help researchers design studies. E-clinical solutions provider Perceptive Informatics, an arm of CRO PAREXEL, unveils an Internet-based version of the Designer module for its DataLabs EDC solution. The online access provides for collaborative trial design.

The module, which can be hosted by the solutions provider, features a library of study design components that users can validate, test and reuse. The library includes standardized forms with edit checks; forms can be adapted for multiple trials. A hybrid capability accommodates sites using paper case report forms and supports existing paper processes.

Meanwhile, Munich-based XClinical will unveil ODM Study Composer. The point-and-click tool, based on a central XML metadata set, is a validated software design aid for case report forms and data validation plans. XClinical also makes the Marvin EDC system.

ODM Study Composer allows researchers to build and use an item, as well as a CRF library for the re-use of items and CRF definitions. Both legacy and CDISC metadata are supported. In addition to e-CRF design, Study Composer provides for export of the annotated CRF, data validation plan, database specs and other documents.

- here's the Perceptive Informatics release
- see the XClinical announcement

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.