Managing clinical trials are quite complicated as the healthcare industry is highly regulated and the increasingly global marketplace can be extremely challenging. It calls for an integrated, end-to-end approach that synchronously provides visibility into trial costs, study timelines, and regulatory compliances. Technology comes to the aid of clinical researchers in addressing some of these challenges.
Yet, Electronic Clinical Trial Management System can be vulnerable to organizational boundaries, siloed information, different systems, and non-standardized processes, resulting in an unnerving case of “You don’t know what you don’t know.” Clinical investigators need to adapt a system that allows them to seamlessly integrate all aspects of study management including scheduling, tracking compliances, coordinating with other researchers and participants, and maintaining records with audit trail. The ultimate objective is to fast-track and fool-proof product development.
For several years, increasing numbers of healthcare organizations have implemented Electronic Clinical Trial Management Systems (E-CTMS) that can provide insights collected from the system’s data to gain early and increased visibility into problems, progress, and possibilities.
Many organizations have a constant need to expand Electronic Clinical Trial Management System capabilities, integrate clinical operations data across multiple systems, and update clinical trial developments – all in order to prepare for changing regulatory requirements and clinical trial practices. This is the obstacle faced by clinical researchers and lead investigators when choosing a CTMS solution to manage clinical trials – go with an existing solution or explore alternative options.
A standard Clinical Trial Management System defines and manages all of the activities that span the lengthy and rigorous clinical trial processes.
A CTMS can assure clinical researchers that “you know what you should know.” It transcends organizational boundaries, develops interoperability, and reports evolving regulatory standards. It retains and manages clinical trial planning, preparation, performance, and reporting, with a significance on keeping up-to-date contact information for experimental applicants and trailing targets and milestones (e.g., for obtaining regulatory approval, distributing drug supplies, or issuing progress reports). Typically, an Electronic Clinical Trial Management System (E-CTMS) provides data to business intelligence (BI) method, which acts as a digital dashboard for clinical trial managers.
A healthcare organization exploring the selection of a CTMS should expect the solution to deliver the following core competencies:
The benefits of using a CTMS can be significant and outweigh such challenges. Potential benefits include:
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