Clinical trials management

Owing in part to the excellent, sophisticated computerized tracking systems extant within CRLs, sponsors can utilize this asset to form the basis of a simple, cosf-effecfive, real-time trial status system. While not as potent as a Clinical Trial Management System (CTMS), this approach supports study metrics that may be adequate for multiple sife fri-als involving nutraceuticals and nafural producfs. 

During the conduct of the trial, constant communication between sponsor, vendor, inveshgator and investigahon teams is critical. There is real value in this process, particularly if all parties uhlize a Clinical Trial Management Software System (CTMS) that coordinates all trial activities involving the Clinical Research Coordinator (CRC) at the site and the project managers at the sponsor and CRO locations. 

IT advances have already had a major beneficial impact on medical product development and registration. Some of the major advances in this area are electronic filing of applications for regulatory approval, RCDC, and clinical trial management software. The application of software to the analysis of the genetic profile of large patient populations is an example of the powerful intersection of pharmacogenomics and IT. 

Whether your clinical trials management system was developed in-house or purchased from a vendor, eventually you will have the opportunity to experience an upgrade. At some point you will probably need to upgrade the operating system on the PC or server, the version of the database that your application is built on, or the application software itself. Worst case is when you have to upgrade all of these at once. 

At times, owing to insufficient preparation and management, the clinical trial falls by the wayside, creating delays in the timelines for market launches. This chapter will focus on the components of clinical trial management procedures from execution to closure. 

Clinical research and clinical trials management are also on the increase within the bioengineering and biotechnology framework. Singapore is the Asia Pacific Economic Cooperation (APEC) Coordinating Centre for Good Clinical Practice, and has implemented many initiatives, such as the training of clinical... 

Zhao W, Pauls K (2016) Architecture design of a generic centrahzed adjudication module integrated in a web-based clinical trial management system. CUn Trials 13 223-233... 

Risk-management System I Information relating to Clinical Trials... 

Carroll KM, Sinha R, Nich C, er al Conringency management to enhance naltrexone treatment of opioid dependence a randomized clinical trial of reinforcement magnitude. Exp Clin Psychopharmacol 10 5d—63, 2002 Carroll KM, Fenron LR, Ball SA, er al Efficacy of disulfiram and cognitive behavior rherapy in cocaine-dependenr ourparienrs. Arch Gen Psychiatry 61 264—272, 2004... 

Electronic-based data collection and management systems use various computer hardware and software technologies. Although some organizations design and develop their own systems, others purchase well-established e-clinical trials software from a wide range of vendors. 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

Web-based data collection and management systems provide a mechanism for remote data entry, where entered data are added to a centralized database once the submit button is pressed. They can be designed to automate the various aspects of clinical trials such as eligibility evaluation, data collection, and tracking specimens. They also serve as a resource site for participating sites to access trial-specific information, facilitate communication, track data queries and their resolutions, and allow administrative management of trials [28, 29]. For these reasons, they play an important role in facilitating the conduct of international clinical trials. 

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