Clinical Trial Management System

Clear and simple definition

A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages the planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.

Terminology

eClinical is a term used within the bio-pharmaceutical industry to refer to trial automation technology. Originally, “eClinical” was used to refer to any involved technology. Without a more specific definition, the industry used “eClinical” to name technologies such as electronic data capture, clinical trial management systems or Randomization and Trial Supply Management systems, commonly using Interactive voice response systems, electronic patient diaries, and other applications.

More recently, the term evolved to encompass the entire “business process” instead of individual technologies. An example of an “eClinical solution” is the combination of EDC and IVR systems where common data are shared in a way that eliminates the need for users to enter the same data or perform the same action in both applications. The shift in the definition of “eClinical” has been a natural part of the industry’s evolution to seek better ways to utilize multiple technologies together within a clinical trial.

Background

While individual solutions have helped to automate or streamline particular application areas, maintaining multiple systems containing overlapping data and functionality brought significant inefficiencies. The industry found that eliminating data discrepancies between systems has reduced data reconciliation activities and helped ensure that those responsible for a clinical trial always has accurate and up-to-date information.[As the number of relevant applications increases with greater adoption of EDC and other technologies, the problems of duplication of data and redundancy in the process have increased. As a consequence, the pursuit of an integrated technology suite to streamline workflows and improve usability has become a key characteristic of the industry’s latest “eClinical” approach. Furthermore, It improves productivity by reducing the need for internal staff to input data.

uper row represents CT work flow, lowe row is work flow of the SME using the CT data