DATATRAK International Profile
DATATRAK International, Inc., a technology and services company, focuses on providing global eClinical solutions for the clinical trials industry. The company, as an application service provider (ASP), provides electronic clinical trials technology referred to as electronic data capture (EDC) to the clinical trials industry. Its customers use its software to collect, review, transmit and store clinical trial data electronically.
DATATRAK Software and Services
The company’s system consists of various modules designed for adaptation to the clinical research process. It initially provides a set of electronic data forms that can be modeled to suit the needs of each particular clinical trial.
The company’s DATATRAK eClinical software suite provides the following capabilities: EDC, interactive voice response systems (IVRS) (via phone or Internet), medical coding, Web-based randomization, clinical trial management system (CTMS), clinical data management system (CDMS), drug inventory management, digitized electrocardiograms, image collection, viewing and storing capabilities and workgroup collaboration capabilities. The company’s legacy-based point solution known as DATATRAK EDC, is a software product that provides electronic solutions for the global clinical trials industry.
The company's products have been utilized in various aspects of the clinical development of 16 separate drugs and one medical device that have received regulatory approval from either the United States Food and Drug Administration (FDA) or counterpart European regulatory bodies (EMEA).
The company’s CRO Connect and Enterprise Transfer program allows customers to become empowered to design, set up and manage their clinical trials independently through its ASP delivery.
Customers
The company’s customers are companies in the clinical pharmaceutical, biotechnology, contract research organization (CRO), and medical device industries. Its major customers include Otsuka Research Institute, Gilead Sciences, Inc., Allergan, Inc., and Seattle Genetics, Inc. The company markets its software and services through a sales and marketing staff located in the United States and Europe.
Significant Events
The company has a strategic partnership agreement with Inclinix Inc. to offer enrollment services available to pharmaceutical, biotechnology, and medical device companies.
History
DATATRAK International, Inc. was founded in 1991.
