Clinical trial management system
A Clinical Trial Management System (CTMS), is a customizable software system used by the biotechnology and pharmaceutical industries and clinical research institutions to manage the large amounts of data involved with the operation of a clinical trial. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones, such as those for regulatory approval or the issue of progress reports.
Usage of term
eClinical is a term used within the biopharmaceutical industry to refer to electronic systems for automating the management or conduct of clinical trials with the aim of replacing manual, ad hoc or paper-driven methods. Originally, "eClinical" was used to refer to any technology application in use within a clinical trial. Without a more specific definition, the industry used "eClinical" interchangeably to refer to number of different technologies, such as EDC solutions (Electronic Data Capture), CTMS (Clinical Trials Management System) or Randomization and Trial Supply Management systems, commonly using IVRS (Interactive Voice Response Systems), electronic patient diaries and other common types of electronic solutions widely used in clinical trials. Due to various acquisitions, Oracle currently has the most comprehensive suite of "eClinical" applications.
More recently, the usage of the term "eClinical" has evolved from this earlier reference for any clinical trial technology to a more specific context focused more on business process than on individual technologies. Increasingly, the term is being adopted to convey the concept of integrated technologies utilized in clinical trials - technology products working together as solutions, sharing data, eliminating duplication of activities, and streamlining the use of multiple technologies for end users. Therefore, 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.
While individual solutions have helped to automate or streamline their particular application areas of the clinical trial process, maintaining multiple systems containing overlapping data and functionality has also brought significant inefficiencies for trial sponsors and technology users. The industry has found over time that eliminating data discrepancies between systems has reduced data reconciliation activities in addition to ensuring that those responsible for a clinical trial always have 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 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.
In the early phases of clinical trials, when the number of patients and tests are small, most managers use an in-house or home-grown program to handle their data. As the amount of data grows, though, organizations increasingly look to replace their systems with more stable, feature-rich software provided by specialized vendors. Each manager has different requirements that a system must satisfy. Some popular requirements include: budgeting, patient management, compliance with government regulations, and compatibility with other data management systems.
Each sponsor has different requirements that their CTMS must satisfy; it would be impossible to create a complete list of CTMS requirements. Despite differences, several requirements are pervasive, including: project management, budgeting and financials, patient management and recruitment, investigator management, EC/IRB approvals, compliance with U.S. Food and Drug Administration (FDA) regulations, and compatibility with other systems such as data management systems, electronic data capture, and adverse event reporting systems.
In addition to pharmaceutical and biotechnology industries, CTMSs are also widely used at the sites where clinical research is conducted such as research hospitals, physician practices, academic medical centers and cancer centers.
While pharmaceutical companies that sponsor clinical trials may provide a CTMS to the sites that participate on their trials, sites can also benefit from having their own CTMS to support their day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators, providing a centralized place to house all trial-related information, and making clinical data management more efficient by equipping staff, including biostatisticians and database administrators, with the time-saving tools necessary to optimize productivity.
- ClinPage: 5 Definitions of "Eclinical"
- R Case, "In Search of the Holy Grail – Chasing ultimate clinical trial efficiency, one small step at a time", Pharmaceutical Executive, July 2005
- B Harper, "Meshing EDC with CTMS", Bio-IT World, February 2007
- J Mcllwain, "A to Z Trial Integration", Applied Clinical Trials, October 2007
- Choi, Byungsuk; Stan Drozdetski, BS, Margrethe Hackett, BA, Can Lu, BS, Cari Rottenberg, BS, Linda Yu, BA, Dale Hunscher, BA, and Daniel Clauw, MD (2005). "Usability comparison of three clinical trial management systems". AMIA Annu Symp Proc.: 921. Retrieved 13 February 2013.
- Leroux, H; McBride S, Gibson S (2011). "On selecting a clinical trial management system for large scale, multi-centre, multi-modal clinical research study". Studies in Health Technology and Informatics 168: 89–95. PMID 21893916. Retrieved 13 February 2013.
- Shankar, Ravi D.; Susana B. Martins, Martin J. O’Connor, David B. Parrish, Amar K. Das (2006). "Towards Semantic Interoperability in a Clinical Trials Management System". Lecture Notes in Computer Science 4273: 901–912. Retrieved 13 February 2013.
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