Chiltern International has stepped up its commitment to electronic data capture (EDC) in clinical trials through agreements with fellow UK company ClinPhone and US-based Medidata Solutions.

The contract research organisation (CRO), which manages a broad range of Phase I-IV studies through 18 offices across Europe, the US and India, showed it was serious about EDC when it launched a global support group, EDC Solutions, in January 2005. Chiltern has now boosted its capabilities in the still emerging sector by tapping into the ClinPhone EDC software system and partnering with Medidata for its Rave EDC solution.

Under the agreement with ClinPhone, Chiltern will implement the ClinPhone EDC system to support its global clinical trial programmes. ClinPhone, which broadened its clinical technology offer last October when it acquired EDC specialist DataLabs, describes ClinPhone EDC (formerly know as DataLabs Clinical) as “the industry’s first single data management system that unifies the functionality of paper data entry with the flexibility of electronic data capture into one, easy-to-use electronic clinical data management platform.” Chiltern plans to use the software primarily for EDC and for clinical data management of electronic and paper trails.

The CRO will access the Medidata Rave solution through the US company’s ASPire to Win Program, a non-exclusive application service provider partnership and business model. Medidata will supply the tools and training for Chiltern to implement Rave across its Phase I-IV global clinical development programmes.

Also a single platform that supports both EDC and clinical data management systems functionality, Medidata Rave is “the industry-leading system for capturing, managing and reporting clinical research data”, its owner says. According to Chiltern’s chief executive officer Glenn Kerkhof, the CRO picked Rave as “a leading EDC solution in terms of ease of use [and] implementation. Rave has received an outstanding response from our users."

SAS integration

Medidata has further expanded the applications of its Rave platform by integrating the system with SAS Drug Development, a data management, collaborative reporting and analysis solution offered to pharmaceutical, medical device and biotechnology companies by SAS Institute, Inc. Data collected and managed in Medidata Rave will be immediately accessible through SAS Drug Development, along with other data gathered in the research and development process.

Clinical trial sponsors will benefit from streamlined access to study data “on one uniform, regulatory-compliant data path,” said SAS, a US provider of business intelligence and analytical software and services.

“This integration offers customers an opportunity to revolutionise clinical development by speeding data transparency from patient to p-value,” added Jason Burke, worldwide director of the SAS Health and Life Sciences Global Practice. “In doing so, SAS and Medidata can further push legacy clinical data management systems toward obsolescence.”