DataLabs Announces First Clinical Data Management Software for True Hybrid Clinical Studies

New clinical software release is the first hybrid product on the market that unifies the functionality of paper data entry and the flexibility of electronic data capture into one seamless software solution.

IRVINE, Calif. - January 17, 2006 - DataLabs, an innovative developer of Web-based software applications for clinical development, today announced the general availability of DataLabs Clinical, a single data management system that unifies the functionality of paper data entry (PDE) with the flexibility of electronic data capture (EDC). DataLabs Clinical is an electronic clinical data management platform that enables the biopharmaceutical and contract research organizations (CRO) industries to streamline clinical data management processes and reduce the time and costs associated with clinical trials.

“DataLabs Clinical enables biopharmaceutical companies, CROs, and academic institutions to design a clinical study once, then collect data either through a PDE or EDC mode, then clean and manage the data with the same system, with fast and easy implementation and support," said Jim Langford, president of DataLabs. “Training costs are reduced because users learn one process for cleaning and managing data, and design costs are reduced because studies are designed once and libraries of forms can be created and reused. Now true hybrid studies can be conducted without the difficult and time-consuming data integration from two databases; patient data from both paper data entry and EDC can be captured and managed in the same system and database."

Accelerating Clinical Trials

Datalabs Clinical includes modules for study design, data capture and data management in a single, integrated application designed to accelerate clinical trials. This application is entirely browser based allowing customers the functionality of a thick client application (PDE) with the flexibility of a Web-based system (EDC.) As an electronic clinical data management platform, DataLabs Clinical includes clinical trial status reporting functionality, event notifications pushed to external platforms, such as email and mobile phones, and the availability of connectors to “best of breed" external applications.

DataLabs Clinical Delivers:

• True hybrid studies: Data can be entered from either EDC or paper within the same study, from the same site and from the same patient. This provides flexibility in data collection never before possible.

• Time and cost savings: Learn a similar process for cleaning and managing the data, regardless of how the data is entered.

• Single study design: Collect the data in any mode – paper, EDC or hybrid. The study Designer is document based so extensive libraries of data capture screens can created and reused for either paper or EDC.

• Easy transition from paper to EDC: Since the process to manage the data is the same, there is little additional training required.

• Data Management 24/7: Easily attainable through a globally distributed workforce using an entirely Web-based system.

“PRA International chose DataLabs Clinical because of its ability to handle PDE and EDC seamlessly and customize it according to the needs of our sponsors," said Greg Johnson, vice president of Global Data Management at PRA International. “DataLabs’ business model enables PRA to purchase the software and manage it according the needs of each of our sponsors, which gives us more control over how we host and control the data." PRA International, a leading global clinical research organization, will deploy DataLabs solution for clinical trials to gain efficiencies and to create a company-wide standard for collecting clinical trial data in an effort to improve cycle times, reduce costs, and rapidly implement an enterprise-wide tool to clean and manage data faster and with higher consistency.

Easy to Use and Integrate

Based on Microsoft technology, DataLabs Clinical is intuitive and easy to use, operate, and support. The software adjusts easily to operating procedures already in place and integrates easily with other applications and legacy systems. It is built on a service-oriented architecture (SOA) that adheres to open standards, such as CDISC and Web services, and maintains exposed APIs that create a platform on which other clinical development applications can connect.

Providing Value to Specific Industry Segments

• Contract Research Organizations (CROs) – DataLabs Clinical CRO Edition is a highly configurable clinical data management system with a business model that allows CROs to increase revenue and lower costs while providing added client value.

• Small and Mid-Sized Biopharmaceutical Companies – a DataLabs Clinical Pharma Edition delivers a validated, 21 CFR Part 11 compliant data management system that can be installed, validated and trained on within one week, and that doesn’t require special features and enhancements to use and support.

• Large Biopharmaceutical Companies – DataLabs Clinical Pharma Edition is a single application that unifies paper data entry and EDC in a clinical data management platform. It enables simple integration with legacy and commercial systems, regardless of underlying technology.

• Academic/Clinical Institutions – DataLabs Clinical Pharma Edition is a simple to learn, easy to use, validated and compliant data management system that can integrate with other internal systems and at a total cost of ownership that meets non-commercial business requirements.

Pricing and Availability

DataLabs Clinical is available now directly from DataLabs and is sold under a perpetual license model or under an ASP model, which allows clients the greatest flexibility to match their business needs. Under the perpetual licensing model, the software can be installed in the clients’ environment and with knowledge transfer; the client can conduct either traditional heads down double data entry or EDC with the same system, which will provide them the greatest ROI and lowest cost of ownership. The software and implementation costs are fractional to traditional data management systems and are based upon user levels. Pricing is based upon the clients’ specific situation and needs. Please contact DataLabs for a proposal.

About DataLabs

DataLabs is an innovative developer of Web-based applications for clinical development that helps the CRO and biopharmaceutical industries accelerate clinical trials with proven software for study design, data capture and data management. Based on Microsoft platform technology, XML Web services and CDISC ODM standards, the DataLabs Clinical product suite adapts to established operating procedures and integrates easily with existing technology systems. As a result, DataLabs Clinical customers enjoy a low total cost of ownership and high return on investment. Major pharmaceutical companies, government entities, healthcare organizations and contract research organizations (CROs) are currently realizing time and cost savings using DataLabs Clinical. DataLabs, a Microsoft Certified Partner, is based in Irvine, Calif. with East Coast offices in Pennsylvania. For more information, please visit www.datalabs.com.