Press Release

Medidata Solutions Drives Industry to State-of-the-Art E-Clinical Suite; Establishes Dedicated Integration Center of Excellence

Medidata Solutions Drives Industry to State-of-the-Art E-Clinical Suite;
Establishes Dedicated Integration Center of Excellence
Rave Platform Serves as the Hub of the Clinical Enterprise, Enabling Integration
Across All Applications and Support for Industry Standards: CDISC, E2B and HL7

NEW YORK, NY – July 11, 2006 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced the expansion of its research and development capabilities through the formation of its Integration Center of Excellence, which is designed to deliver an enterprise-wide e-clinical suite based on industry standards. With Rave at the core of the e-clinical suite, Medidata is delivering biopharmaceutical companies seamless integration with all best-of-breed applications across the enterprise—providing accurate and efficient workflows without the significant programming, validation and maintenance efforts associated with traditional e-clinical implementations.

According to Chris Connor, senior research analyst at Health Industry Insights, an IDC company, “Integration between clinical applications today is comprised of mainly point-to-point interfaces between individual applications. These implementations require that biopharmaceutical companies spend a considerable amount of their own time and resources to sustain enterprise-level systems.”

“The EDC industry has traditionally been focused on what are effectively point solutions for individual clinical trials, using many small databases, each dedicated to a single clinical trial. The results have been high maintenance and integration costs, as well as very limited abilities to aggregate and analyze data in real-time across multiple studies,” said Glen de Vries, CTO of Medidata Solutions. “A modern EDC implementation, however, requires a single-instance approach, where an organization places all of its studies, across all therapeutic areas and within all geographic regions, in one database. Our customers have proven the success of this approach with Rave’s single-instance architecture, and Medidata’s Integration Center of Excellence is an indication of our commitment to continue to weave EDC and clinical data management seamlessly into the fabric of their enterprise infrastructure.”

With increased EDC adoption and enterprise-wide deployments on the rise, Medidata’s Integration Center of Excellence meets the growing customer need for rapid delivery of robust system interfaces based on industry standards. Medidata’s integration strategy includes:

Support for clinical trial standards, including CDISC for clinical data, E2B for safety cases and HL7 for interaction with hospital electronic patient records;
Support for technical standards, including web services and Service Oriented Architectures (SOA);
Flexibility to interface with legacy systems with limited integration options, such as via ASCII file import and export;
A system architecture that facilitates plug-and-play addition of new interfaces;
Open, documented application programming interfaces (APIs).

Medidata has already integrated its Rave electronic data capture and clinical data management solution with over 30 systems, including clinical drug safety, interactive voice response, clinical trial management, patient diary, laboratory and clinical coding. Its new Integration Center of Excellence, which expands on these integrations, has already proven successful with leading biopharmaceutical companies.

A Showcase: Integration of CDISC clinical data and metadata
A top 10 global pharmaceutical company recently asked Medidata to integrate Rave into its enterprise-wide infrastructure using Service Oriented Architectures (SOA) and CDISC standards. Using pre-existing integration components, Medidata was able to:

Populate Rave’s global library with metadata received in CDISC ODM format, so that new studies are built with minimal effort and consistent standards;
Create new Rave study definitions directly using CDISC ODM metadata, as well as automatically creating human-readable study specification documents as part of the same definition process;
Extract patient data from Rave and broadcast it via the sponsor’s SOA integration platform to other connected systems;
Load data from HL7 data streams to demonstrate how Rave can interact directly with medical devices.

Leading Medidata’s new integration initiative is Andrew Newbigging, who brings more than 15 years of life sciences software development to his position as senior director of research and development. “Medidata continues to be on the forefront of enabling efficient clinical development through innovative technology. Our integration strategy is already reaping benefits for our customers who are leveraging off-the-shelf integration solutions that eliminate the costly programming efforts required with traditional integrations,” Newbigging commented.

About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology and medical device companies realize the maximum potential value from their clinical research investments. Working with companies large and small, Medidata Solutions helps accelerate the process of bringing life-enhancing treatments to market—on five continents and in more than 70 countries. Innovative process design, technology and services can streamline clinical trials by providing early visibility to clinical data for faster decision-making, optimized resources and lower execution risk. Medidata Solutions’ broad client base and deep clinical experience provide value for the world’s leading pharmaceutical, biotechnology and medical device companies, expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. To learn more about Medidata Solutions, please visit

Susan Lombardo
Lois Paul & Partners