Datatrak to facilitate clinical trial process using Electronic Data Capture

Cleveland 18 June 2002Datatrak International Inc., an Application Service Provider (ASP) in the Electronic Data Capture (EDC) industry, is co-operating with DaVita Clinical Research, a subsidiary of DaVita Inc. and MedTox Scientific Inc. to optimise the integration of clinical trial data between clinical research sites and reference laboratories. MedTox Scientific provides products and services for central laboratory and bio-analytical testing for pharmaceutical clinical trials. DaVita Clinical Research is a provider of research services to the pharmaceutical industry. In addition, Datatrak EDC has also been selected as the preferred product suite for implementation in clinical trials for an oncology division of a top twenty global pharmaceutical company.


Data collection in clinical trials often involves third party reference laboratories in order to assure efficiency and consistency in reporting. As the clinical trials industry progressively moves toward the use of technology in the collection, dissemination, and review of data, the integration of information from a variety of inputs and locations will become increasingly important.

The relationship among Datatrak, DaVita Clinical Research and MedTox Scientific will expedite and standardise data transfer from centralised laboratories and clinical research sites, thus avoiding the cumbersome, more expensive and delayed option of manually transcribing laboratory test results into case report forms used at clinical trial sites.

The relationship was initiated through DaVita Clinical Research, which specialises in conducting clinical trials for the worldwide pharmaceutical and biotechnology industry in speciality populations including renal, haepatic, cardiovascular and diabetic patients. DaVita Clinical Research is a Phase I-IV clinical Trial site and SMO located in Minneapolis, Minnesota. DaVita has been conducting clinical trials for over seventeen years and is known for its Phase I Pharmacokinetic, Pharmcodynamic, Bioavailability, and Radiolabel trials along with its Phase II-IV trials in speciality populations. DaVita is part of the US Renal Network, and specialised in renal and renal related trials.

The requirement for technology implementation led to the development of an integration strategy involving Datatrak EDC as the preferred product suite for the collection of clinical research information at the trial site and Datatrak's data loader for the transfer of laboratory results from MedTox using XML standards developed by the Clinical Data Interchange Standards Consortium (CDISC).

The three companies intend to leverage this integration capability throughout the global clinical trial marketplace as the most efficient and cost-effective method of expediting investigative information to clinical trial sponsors and investigative sites. MedTox Scientific Inc. is a provider of high quality specialised laboratory and on-site/point-of-collection (POC) devices. The company also supports customers with complete logistics, data and programme management services.

MedTox develops and manufactures diagnostic devices for quick and economical on-site/point-of-collection analysis for drugs of abuse, therapeutic drugs and biological and agricultural toxins, and provides employment drug screening and occupational health testing. MedTox is specialised in the provision of esoteric laboratory testing services to hospitals and laboratories nationwide, including both central laboratory and bio-analytical testing for pharmaceutical clinical trials.

"The value of technology in clinical trials will be enhanced greatly by the presence of integration between processes and individual functionalities. Such integration will save the pharmaceutical and biotechnology industries multiples of their investment in recognised efficiencies, relative to the manual options and discontinuous procedures that are largely in place today. The availability of a proven integration should allow all three companies to expand their respective market shares within the clinical trials industry", stated Dr. Jeffrey A. Green, President and Chief Executive Officer of Datatrak.

The selection of Datatrak International's product suite for the oncology division of a major pharmaceutical company was the result of an extensive review of available EDC products and a successful audit of the company's Cleveland, Ohio and Bonn, Germany facilities. Preliminary plans are to initiate clinical trials immediately to be followed by planning and budgeting for another 10-15 Phase II and III clinical trials over the ensuing 24 months. This oncology development team has the goal to create a progressive "e-clinical" technology offering that will include a variety of electronic functionalities to be utilised in data collection, review and integration in clinical trials.

The relationship calls for the eventual implementation of a Level II Technology Transfer between Datatrak International and the pharmaceutical company's internal team of clinical project managers, data managers and safety surveillance officers. A Level II Technology Transfer involves appropriate training and education on the Datatrak EDC suite of products, so internal staff can become empowered to deliver the value proposition of proven accelerated drug development and enhanced data quality independently.

Datatrak EDC has been shown to accelerate clinical trial completion by 30 percent and improve the overall quality of data delivered to pharmaceutical companies by greater than 80 percent, when compared with paper processes.

In a Level II Technology Transfer relationship, Datatrak continues to host the application from its Cleveland, Ohio production facility and provide Solutions Center Services supporting the technology from its Bonn, Germany Global Assistance Center. All services involved with the provision of investigative staff training, electronic case report form (eCRF) design, reporting, and import/export capabilities with Datatrak EDC can be performed by the customer's own certified team at its discretion.

Dr. Green of Datatrak stated:"Some of the reasons this client selected Datatrak EDC over other technologies pertain to the performance speeds at dial-up bandwidths, immediate firing of edit checks, the ability to dynamically insert forms which is critical in oncology studies and the flexibility of Technology Transfer options."

Datatrak International Inc. provides a suite of software products known as Datatrak EDC and related services to the pharmaceutical, biotechnology, and medical device industries. Datatrak EDC delivers clinical research data from investigative sites to sponsors faster and more efficiently than traditional manual methods. Datatrak EDC can be deployed globally via a distributed platform using laptop computers, in a centralised environment with resident hardware, or in a wireless mode, all utilising the Internet.

Datatrak EDC software and its previous versions have successfully supported many international clinical studies involving thousands of clinical research sites and tens of thousands of patients in 38 countries. Datatrak's product suite has been utilised in the clinical development of thirteen separate drugs that have received regulatory approval from either the United States Food and Drug Administration or counterpart regulatory bodies in Europe.

Leslie Versweyveld

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