For those who don’t know much about contract research, a contract research organization which offers support to the biotechnology and pharmaceutical industries in the form of research services got a contract from an outside provider. A CRO may offer solutions like biologic assay development, biopharmaceutical development, preclinical research, commercialization, clinical trials management, clinical research and pharmacovigilance. The contract research organization began in the early 1980s and late 1970s and developed as a part of Pharma Research & Development budgets from 4 percent in the 1990s till 50 percent in the mid-2000s.
The price of bringing about clinical trials is improving significantly. Technology involving mobile technology and analytics can decline these expenses, but the challenge is for both the research methods and the business models to adapt around them. This assumes that technologies can bring out trials well.
In an outstanding paper ‘Transforming the Economics of Clinical Trials’, the authors talk about the introduction of technology in clinical trials.
From the last 10 years, electronic data capture (EDC) done some improvement in transforming this business model. In an EDC-enabled surrounding, electronic forms replaced the paper forms in which sites enter their data into an electronic database. This scientific knowledge has produced some efficiency profits as edit-checks decrease the price of the manual data-query process. Yet the EDC platform was fixed firmly in the traditional clinical research business model, accompanied by legacy concepts across site monitoring and validation.
The new chances for the principal statistical monitoring of data in these systems were not embraced far apart. Patient screening and recruitment rates remained largely unchanged. Later on, they propose the mining of EHRs for data for the recruitment and screening of patient research subjects and mobile technologies to collect direct data. What is mainly pointed out is the prevailing absence for a technology-based business model. The report goes on to discuss the observation of trial sites. Both the FDA and the European Medicines Agency have supported the centralized observation of trials through technology on a real-time basis.
Exco Intouch is the leading provider of mobile tools for clinical trials. InVentiv Health is a contract research organization that has lately become active in the mobile side of clinical trials. Finding new patients is another side of digital technology in clinical trials. Pfizer made use of social media to recruit patients for a clinical trial of Detrol One organization holding 200000 patients in online communities which collected data on 150000 disease states.
The other benefit of mobile clinical trials involves less biased recruitment through crowd sourcing, better medication tracking through pill sensor technology, a substantial reduction in costs and faster reporting of inauspicious events which possess the capacity to save lives and cease negative studies earlier through the transmission to Data Safety Monitoring Board. Moreover, they might lend themselves to more efficient audits and will build up the assistance of caregivers who can accept and transmit data with or for the patient in the trial. The digitalization of clinical trial data proved an important step in improving the process and quality of trials.
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