Are your Information
Technology needs being met ?
We can help you regain control of the process and address the issues without getting lost in the details. We have a proven record of assisting in the control of information technology for clinical trials.
Do you have control of your data or is it out of control ?
Marketing of pharmaceutical products today requires the demonstration of efficacy and safety in a program of clinical trials that typically lasts several years, places the product in the hands of dozens of independent investigators, and exposes thousands of patients to its benefits and risks.
During this clinical trials program, huge amounts of information describing the subjects pre-study, study, and post-study conditions flow from their source in the field to the company. This data base is a key resource of pharmaceutical product development in the clinical area. From it, the pivotal questions of safety and efficacy are answered for regulatory agencies and management, and a new product's initial degree of success is determined. It is the asset the company purchases when it finances a clinical trials program.
Managing and controlling this asset is a major and complex activity in drug development. The volume of information is large, it is compiled from a variety of sources separated by distance and time, and those interested in using the information have varied needs and backgrounds.
Effective use of the clinical data base asset requires placing it in a structured environment. This structure must be a symbiosis of processes, personnel, systems and technology. We can act as the catalyst to merge diverse skills, techniques and products into a unified structure.
2004 Strategic Resource Management Associates, Ltd.