June 13, 2007
Simulating Adaptive Trials
The Tessella Adaptive Trials Simulation Toolkit is designed to better equip the pharmaceutical community to carry out adaptive clinical trials that attempt to increase trial efficiency by breaking out of the straightjacket of conventional experimental design. The product contains a range of adaptive trial models for simulating different adaptive methods from phase 1 through 3. The product includes a Bayesian model for phase 2 trials called NDLM dose finder, and a Seamless Phase 2/3 Simulator. (See Bio•IT World, May 2007.)
Product: Adaptive Trials Simulation Toolkit
For More Information: www.tessella.com
Data Visibility in Real Time
Raining Data’s TigerLogic Clinical Trials Data Services (CTDS) allows drug sponsors to aggregate clinical trial data in real time to provide real-time visibility across all trials. TigerLogic CTDS accepts clinical data in any format and from any Electronic Data Capture (EDC) system used by a sponsor or CRO. This data is validated based on business or regulatory rules (such as 21 CFR Part 11) and transformed into the industry standard CDISC Operational Data Model. The platform is comprised of two major components, the TigerLogic XML Data Management Server (XDMS) and the TigerLogic XML Workflow Management Server (XWMS).
Product: TigerLogic CTDS
Company: Raining Data
For More Information: www.rainingdata.com
Cleaner Data More Quickly
Phase Forward’s Central Coding for InForm product is a Web-based coding and dictionary management application that automates the coding process and minimizes the manual effort required to code verbatim terms. Optimized to work with the InForm Integrated Trial Management system, Phase Forward’s electronic data capture product, Central Coding for InForm automatically standardizes clinical trial data input to provide cleaner data more quickly and efficiently for organizations conducting clinical trials.
Product: Central Coding for InForm
Company: Phase Forward
For More Information: www.phaseforward.com
Finding the Right Patients
Prism PRT represents the latest innovation in patient recruitment tools. This tool is built to interact with clinical data, EDC, and CTMS systems used in clinical trials. PRT capitalizes on a number of current industry trends, most notably the emergence and growth of the Electronic Health Records market, the onset and adoption of CDISC data interchange standards, and new web technologies such as Java, Flex, and AJAX. The product stores elegibility criteria, converts all data sources to CDISC ODM, and then applies the protocol rules analysis to the ODM file to find patients that match. Those patients are passed through Prism’s randomization feature to be enrolled in a study.
Product: Prism PRT 1.0
For More Information: www.nextrials.com
Medidata Rave 5.6 is the new release of Medidata’s electronic clinical data capture, management, and reporting solution. Building on Rave’s single platform, Rave 5.6 introduces new features including study build, data capture, and data management that allow global clinical trial teams to collaborate within a single system and extend electronic study benefits beyond a single trial. Designed for pharmaceutical, biotech, and medical device companies as well as research organizations, Rave 5.6 eliminates the need to manage complex integrations and incur additional overhead for deploying and managing separate EDC and CDMS databases.
Product: Rave 5.6
Company: Medidata Solutions
For More Information: www.mdsol.com
Open Source EDC
OpenClinica is a free, open source electronic data capture system for use in diverse clinical research settings. It provides an efficient, flexible, and low-cost way to manage diverse types of clinical research studies. OpenClinica’s community-centric open source model makes powerful EDC technology widely accessible to all types of researchers. The product is the result of an ongoing global collaboration among government, academic, and industry organizations who use OpenClinica to fill their own direct needs, and contribute to the broader community of OpenClinica adopters. The end-to-end open source approach based on leading independent standards, such as CDISC ODM, delivers a powerful technology that is lightweight, easy to use, and highly interoperable with other systems.
Company: Akaza Research
For More Information: www.openclinica.com