eClinical news in brief

By Kirsty Barnes

- Last updated on GMT

Related tags: Medidata rave, Clinical trial

Outsourcing-Pharma tracks the latest eClinical movements, featuring
Medidata Solutions, TechTeam Global, OmniComm Systems, KineMatik
and Perceptive Informatics.

Medidata Solutions​ has announced that its its electronic data capture (EDC) system, Medidata Rave, has received Clinical Data Interchange Standard Consortium (CDISC) Operational Data Model (ODM) certification on all eight available CDISC ODM uses for importing and exporting clinical study data - a first in the industry. The firm said that the certification of Medidata Rave on all eight ODM use-cases "ensures end-to-end system compatibility and effective data exchange in full compliance with the industry's leading standards​". "Medidata's decision to support across-the-board ODM certification was a direct response to our customers' needs and is consistent with our belief that coupling innovation with adherence to industry standards is key to providing sponsors and partners with efficient, interoperable solutions that increasingly streamline the process of clinical development​," said Andrew Newbigging, senior director of research and development at Medidata. "An ever-growing number of companies are relying on CDISC for industry standards​," he added. CDISC is a global, industry-supported non-profit organisation that establishes standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. It introduced the ODM certification program in 2007 to ensure consistency across toolsets and interoperability between ODM implementations. The ODM Standard is currently recognised as the "ideal​" transport method for data across the entire clinical trial enterprise, the organisation said. Meanwhile, Medidata also announced the expansion of its ASPire​ to Win partner programme due to a "growing opportunity​" for contract research organisations (CROs) and service providers to meet sponsor demand for Medidata Rave. ASPire​ to Win is a non-exclusive enablement and accreditation program that supports selected CROs and other organisations in creating services revenue via the implementation of Medidata Rave. The firm currently has 11 partners under the progrmme. Through the expansion, Medidata said it now offers companies a more flexible programme, providing the "appropriate level of training and support​" for companies of all sizes. To meet customer needs, CROs are building EDC-related services into their portfolios, including EDC site administration, study build and reporting, said Medidata. "With the expansion of ASPire to Win, Medidata offers a flexible program to equip CROs and service providers with various Rave skills to help them optimise their services revenue around this technology.​" "We understand that each organisation has a unique set of goals and requirements for EDC​," said Graham Bunn, vice president of global CRO partnerships at Medidata. "As a result, we've moved away from a 'one size fits all' approach and expanded our programme to enable our global network of business partners to choose the plan that will best meet the needs of their customers and complement their unique capabilities as well as grow their business with Medidata Rave.​" The ASPire​ to Win programme now offers four unique partner levels: Rave Aware​, qualifying partnes to market Medidata Rave, Rave Ready​, which trains partners to provide basic EDC services, Rave Accredited​, where partners are equipped to build and configure their customers' Medidata Rave studies, and Rave Accredited Plus​, where partners can provide the full suite of Medidata Rave-related services, including end user training, study build, reporting, outputs, integrations and migrations, and effectively function as a "one-stop shop​". Recently, IT outsourcing services firm TechTeam Global​ has been enlisted by Sanofi-Aventis Research & Developement to provide help desk and site provisioning services to sanofi-aventis clinical trial investigators on multiple studies in around 50 countries across around the world. Under the deal, TechTeam ill be providing Sanofi-Aventis with eclinical support services, including site assessments, hardware deployments and help desk services in over 20 languages. Christoph Neut, TechTeam's senior vice president for Europe, said that the firm has been focusing its efforts over the last five years on building a "world-class global EDC help desk support platform​," and in the process has added several new multilingual EDC support programs to its portfolio. "This new relationship with Sanofi-Aventis demonstrates that TechTeam's capabilities are acknowledged by leading pharmaceutical and health care companies around the world.​" EDC firm OmniComm Systems​ has revealed that Criterium has become a member of its CRO Preferred Program, which allows Criterium to offer its clients OmniComm's TrialMaster EDC solution for clinical trials. OmniComm said that under the arrangement, Criterium will also benefit from the CRO program's "distinct advantages​", including fixed pricing with no hidden fees, complete sales and marketing support from OmniComm in the selection process, a dedicated, hosted environment and comprehensive training and support for TrialMaster. "Companies are starting to realise the substantial benefits of this program... that other vendors just don't offer. Partnering with OmniComm... gives them a competitive edge in the bidding process​," said Stephen Johnson, COO of OmniComm. Commenting on the company's decision to enter the programme, John Hudak, president of Criterium said: "We have had the opportunity to become familiar with many of the EDC systems in the marketplace and have chosen TrialMaster based on its superior functionality and compatibility with Criterium's StudyControl, our centralised clinical trial data management environment​". "We work successfully with OmniComm and TrialMaster, along with our other data sources, integrates seamlessly with our data management system. We appreciate the right mix of a superior EDC product and the real dedication to customer service that the OmniComm-Criterium team delivers.​" Meanwhile, KineMatik​ has announced it will be displaying its new Clinical Trials module for the first time next Tuesday at BioIT World Conference and Expo 2008. Called eNovator Clinical Trials, the firm said the module is is designed to "simplify and streamline​" the process of conducting a clinical trial. Using a template-based approach, eNovator allows users to "easily​" launch new trials, ensuring consistency in business processes and adherence to the trials protocol, said KineMatik. "All patient information, trials tasks, and critical milestones are captured, monitored, and reported on, ensuring the trial stays on budget and on schedule​," the firm said. "eNovator helps reduce errors, improve visibility, provide consistency in how trials are conducted and maintain regulatory compliance throughout the trials process.​" In other news, Perceptive Informatics​, the technology subsidiary of Parexel, has recently announced the availability of Impact MySites, its monitoring solution for its clinical trials management system (CTMS), on a portable USB drive, in order to create a more mobile eClinical environment. The firm said that the new portable functionality will benefit clinical monitors, as they can can now securely upload site visit information onto the USB drive, which requires no software installation, threfore eliminating the need for them to carry their laptop computers with them. "We expect that clinical monitors will benefit from increased flexibility, productivity, and efficiency with the option to easily and securely capture site visit information from anywhere in the world at any time, using the new portable functionality of the Impact MySites USB drive​," said Todd Joron, corporate vice president and general manager of Perceptive Informatics.

Related topics: Clinical Development, Data management

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