eClinical Software: July 2009

July 1, 2009
Lisa Henderson
Applied Clinical Trials

Volume 0, Issue 0

The latest eclinical software in the clinical trials industry.

CRA Functions Added to EDC/CDM System

Rave Monitor provides CROs and sponsors with increased site visit tools

Medidata (New York) announced Rave Monitor, an extension to its Medidata Rave EDC/CDM software. Rave Monitor provides tools to automate edit-checking, remotely query sites' data entries, and accelerate source data verification to help improve the CRA's ability to work with research sites to expedite the availability of clean data.

Additional module added to Rave

In addition, Rave Monitor provides users with online and offline visit report capture, approval workflow, and inter-study and cross-study status reporting—all within the context of their existing Rave deployment. This means that monitors familiar with Rave through other activities can use the tool with minimal training. Rave Monitor is offered as an additional module for Rave version 5.6.3.

Medidata, (212) 918-1800, www.mdsol.com

Modeling Influx and Efflux Transporters

Regulatory agency influences simulation and prediction platform upgrades

Simcyp Limited (Sheffield, UK) announced Version 9.0 of Simcyp Simulator, which models clinical drug-drug interactions. The new version includes the influx and efflux transporter to reflect "real-life" population variability in the processes of drug absorption, distribution, metabolism, and excretion (ADME) through the conduct of studies in virtual human populations.

Simcyp Simulator Version 9.0 available

In addition, enhancements to trial design elements within the Simulator provide greater flexibility to assess the potential outcomes of Phase I, II or III clinical trials early in the drug development process. Examining complex and potentially unsafe scenarios and assessing the likelihood of such cases via computer allows clinical studies to be optimized, prioritized or abandoned.

Simcyp, +44 (0) 114 292 2322, www.simcyp.com

Compliance Adherence in Research Addressed

Study protocol process automated from inception to approval for IBCs

TOPAZ Technologies (Austin, TX) has added a Biosafety Solution to its product line. The Biosafety Solution compiles, tracks, and manages complex research study data and creates an audit trail with comprehensive reports to prevent and protect against regulatory compliance violations.

New Biosafety Solution debuts

Composed of three unique modules, the solution is designed to address key milestones and compliance requirements. Modules include: the Protocols Module, created to streamline IBC protocol development and store critical research information; the Reviews Module, developed to compile and track activities throughout the IBC protocol review process; and the Meetings Module, designed to schedule and capture IBC meeting activities.

TOPAZ Technologies, (512) 249-8080, www.topazti.com