Pharmaceutical Drug Development & Its Use of Technology
Pharmaceutical drug development communication issues are intimatel...
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Pharmaceutical Drug Development & Information Technology


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Pharmaceutical Drug Development & Information Technology

  1. 1. Pharmaceutical Drug Development & Its Use of Technology Pharmaceutical drug development communication issues are intimately related to our healthcare system's poor use of available technology. While working with a CRO as a marketing associate, I was shocked by the archaic, inefficient performance of an industry whose purpose was to manage and improve the process of moving a drug through development. The issues I identified were: 1. Sending reviewers on-site to obtain FDA required clinical information, when this information should be electronically available on a secure network that organizes, analyzes and submits information automatically from the investigative sites to the pharmaceutical company and the FDA speeding the process of approval, 2. capturing, screening and retention of patients for clinical trials is sluggish without the full use of interactive computerized submission between patient and investigative sites, 3. the lack of a system to qualify or rate the performance of multiple investigative sites when it is the collective quality of these site's performance that improves the time between trial and market launch, 4. poor relationships between CRO, investigative sites and pharmaceutical company as historically investigative sites dealt directly with the pharm co. and view CRO's as a subjugate presence. Antagonistic relations have a direct effect on the cooperative communications necessary for the realization of mutually beneficial goals. Having identified these issues, I began to develop a program that would target and resolve these concerns- an Investigator Relations Program (IRP). 1. Computerize manual data entries connecting CRO, investigative sites to host pharmacy and FDA, 2. Create online communication capabilities to connect patients and their treatments/side- effects/questions to investigative sites improving capture, screening and retention, 3. Develop a "rating" system to qualify investigative sites and mentor improvements, 4. Initiate conferences, on-site marketing presence to address investigator concerns improving reciprocity and collaborative efforts. Upon exiting the industry to found a comprehensive medical management company, I realized that the primitive technological state of our hospitals, insurers, discharge facilities, pharmacies, home health agencies, durable medical equip and ambulance co were identical to the drug development industry. We are seeking funding to complete programming and introduce a nationwide, online network that captures clinical information and utilizes computerized algorithms to document, organize, analyze and problem-solve. This system can be developed to achieve the same functions in the Drug Development Industry decreasing costly, inefficient workforce, dramatically improving the time between drug trials and market introduction.