DataLabs’ Announces eClinical Collaboration Software to Manage Clinical Trial Processes

DataLabs’ Site Manager ™ greatly improves site administration and accelerates clinical development.

IRVINE, Calif. - February 14, 2006 - DataLabs, an innovative developer of Internet-based software applications for clinical development, today announced Site Manager™ as an integrated addition to their eCDM platform. DataLabs’ Site Manager is advanced clinical trial software that enables collaborative processes to quickly identify, select and initiate investigator sites. It also allows easy monitoring, administration and communication with sites during the clinical trial.

Site Manager, designed to improve workflow and communication in clinical trial processes, was developed by Broadpeak and purchased by DataLabs in 2005. Site Manager enables contract research organizations (CROs) and biopharmaceutical companies to accelerate the recruitment, selection, and origination of new clinical trial sites by streamlining document processing and improving communication among clinical trial participants. Customers benefit from Site Manager through:

  • Site Database management – create, maintain and access database of investigators

  • Site Selection – facilitate site evaluation and exchange trial agreements

  • Site Initiation – manage regulatory documents, investigator meetings and training

  • Site Monitoring – provide study teams with a central place to track and report on visits

  • Site Relationship Management – maintain a continuous and updated line of communication with investigator sites

“The widespread use of the Internet among investigative sites has created communities of connected users that can now use collaborative technologies to monitor clinical trial activities and communicate in real time," said Nick Richards, COO of DataLabs. “With the integration of Site Manager to our eCDM platform, we can now provide customers with the best tools for the next generation of clinical trial management."

Site Manager facilitates all internal and external collaboration for study activities, from start to finish and it accelerates the time for recruiting qualified investigators, initiating each site (including the collection and versioning of regulatory documents), communicating with investigative sites, and providing a central portal in which to manage the progress of each clinical trial.

Site Manager differs from traditional clinical trial management systems in that it actually helps facilitate the completion of many tasks while also tracking project tasks. In this way, Site Manager reduces cycle times for clinical operations teams, increases visibility into trial progress and reduces hard costs related to printing, packaging and shipping documents. Site Manager has been designed to work in coordination with other trial and data management systems to ensure a consolidated view of clinical trials.

DataLabs’ eClinical Collaboration software suite is based on Microsoft .NET technologies and built using CDISC ODM standards to foster data exchange and interoperability. Site Manager is designed to comply with FDA 21 CFR part 11.

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 eClinical Data Management, eCollaboration, and eLearning. Based on Microsoft platform technology, XML Web services and CDISC ODM standards, the DataLabs eClinical Solution product suite adapts to established operating procedures and integrates easily with existing technology systems. As a result, DataLabs’ 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 eClinical Solutions. DataLabs, a Microsoft Certified Partner, is based in Irvine, Calif. with East Coast offices in Pennsylvania. For more information, please visit www.datalabs.com.

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DataLabs to Integrate Galt’s dsNavigator Coding Product with Their Hybrid Clinical Data Management Platform to Improve Coding Consistency and Increase Cost Savings

IRVINE, Calif. - February 8, 2006 - DataLabs, an innovative developer of Web-based software applications for clinical development, today announced a partnership with Galt Associates, an international leader in managing risk through information, to integrate Galt’s dsNavigator coding and dictionary management product with DataLabs eCDM platform. The result is a single integrated solution that combines the robust features of two best-of-breed software applications.

“Customers are looking for sophisticated coding solutions to complement their clinical data management operations," said Nick Richards, COO of DataLabs. “We considered all of the offerings in the marketplace and found Galt’s product to be the best fit for our growing number of customers who demand robust features and a low total cost of ownership. We are excited about our partnership with Galt and look forward to working together to bring new innovative products to market."

DataLabs Clinical, a single data management system that unifies the functionality of paper data entry (PDE) with the flexibility of electronic data capture (EDC), 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. Galt’s dsNavigator is a trusted and proven Web-based solution that offers rapid and accurate coding of adverse event and drug verbatims throughout each phase of clinical research. Featuring a configurable and easy-to-use interface, it provides a single solution for dictionary management, searching, browsing and batch or interactive coding. dsNavigator allows all parties involved to effectively assign, review and communicate coding decisions regardless of differences in terminology, dictionary versions, training levels or regulatory requirements at any time during the trial. Coupl ed with DataLabs Clinical, this intelligent coding and dictionary management solution saves customers time and resources.

"Galt is extremely pleased to enter into this dynamic new partnership," said Y. Renee Lewis, CEO of Galt Associates. “Datalabs thoroughly understands the importance of the quality and consistency of the data collected. By integrating Galt's products, Datalabs is able to deliver comprehensive efficient solutions to meet the variety of needs of their clients."

About Galt Associates
With over a decade of experience, Galt is an international leader in helping clients manage risk through information. Galt’s evidence-based solutions integrate the recognized expertise of its medical and scientific personnel with innovative technologies to ensure timely answers to clients’ critical questions. This integrated approach allows Galt to deliver medical risk management and communication strategies that address the benefits and risks associated with the full range of medical therapies and interventions. Galt supports over 70 pharmaceutical, medical device, and biotechnology companies, as well as CROs and research institutions located throughout the US and Europe.

For more information about Galt’s products and services, visit www.DrugSafety.com or contact them at info@drugsafety.com or +1 703-547-3388.

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 eClinical Data Management, eCollaboration, and eLearning. Based on Microsoft platform technology, XML Web services and CDISC ODM standards, the DataLabs eClinical Solution product suite adapts to established operating procedures and integrates easily with existing technology systems. As a result, DataLabs’ 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 eClinical Solutions DataLabs, a Microsoft Certified Partner, is based in Irvine, Calif. with East Coast offices in Pennsylvania. For more information, please visit www.datalabs.com.