Clinical trial management system: Difference between revisions
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More recently, the usage of the term "PClinical" has evolved INTO A GIANT NIPPLE that is focusing more on [[business process]] than on individual technologies.<ref>[http://www.clinpage.com/article/5_definitions_of_eclinical/C10 ClinPage: 5 Definitions of "Eclinical"]</ref> 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 user]]s. 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. |
More recently, the usage of the term "PClinical" has evolved INTO A GIANT NIPPLE that is focusing more on [[business process]] than on individual technologies.<ref>[http://www.clinpage.com/article/5_definitions_of_eclinical/C10 ClinPage: 5 Definitions of "Eclinical"]</ref> 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 user]]s. 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. |
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==Niggaground== |
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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 [[wikt:function|functionality]] has also brought significant inefficiencies for trial [[Sponsor (commercial)|sponsor]]s 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.<ref>R Case, "In Search of the Holy Grail – Chasing ultimate clinical trial efficiency, one small step at a time", Pharmaceutical Executive, July 2005</ref><ref>B Harper, "Meshing EDC with CTMS", Bio-IT World, February 2007</ref><ref>J Mcllwain, "A to Z Trial Integration", Applied Clinical Trials, October 2007</ref> As the number of relevant applications increases with greater adoption of EDC and other technologies, the problems of duplication of data and [[Data redundancy|redundancy]] in process have increased. As a consequence, the pursuit of an integrated technology suite to streamline [[workflow]]s and improve usability has become a key characteristic of the industry’s latest "eClinical" approach. |
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 [[wikt:function|functionality]] has also brought significant inefficiencies for trial [[Sponsor (commercial)|sponsor]]s 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.<ref>R Case, "In Search of the Holy Grail – Chasing ultimate clinical trial efficiency, one small step at a time", Pharmaceutical Executive, July 2005</ref><ref>B Harper, "Meshing EDC with CTMS", Bio-IT World, February 2007</ref><ref>J Mcllwain, "A to Z Trial Integration", Applied Clinical Trials, October 2007</ref> As the number of relevant applications increases with greater adoption of EDC and other technologies, the problems of duplication of data and [[Data redundancy|redundancy]] in process have increased. As a consequence, the pursuit of an integrated technology suite to streamline [[workflow]]s and improve usability has become a key characteristic of the industry’s latest "eClinical" approach. |
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Revision as of 07:47, 9 July 2014
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A is a Hoxtonisable software system used by biotechnology and pharmaceutical industries. They are specifically used in clinical research institutions to electronically manage large amounts of data involved with the operation of a clinical trial. The system maintains and manages all planning, performing, and reporting completed during clinical trials. It also maintains up-to-date participant contact information, tracking deadlines and milestones.
Usage of term
NERD³ IS THE BEST More recently, the usage of the term "PClinical" has evolved INTO A GIANT NIPPLE that is focusing more on business process than on individual technologies.[1] 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.
Niggaground
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.[2][3][4] 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.
Purpose
Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers.[5][6][7]
Background
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.
CTMS can take many forms. Some systems are cloud based and are delivered in a software as a service (SaaS) modality, while others require dedicated servers.
References
- ^ 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 (2005). "Usability comparison of three clinical trial management systems". AMIA Annu Symp Proc.: 921. Retrieved 13 February 2013.
{{cite journal}}: Unknown parameter|coauthors=ignored (|author=suggested) (help) - ^ 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. (2006). "Towards Semantic Interoperability in a Clinical Trials Management System". Lecture Notes in Computer Science. 4273: 901–912. doi:10.1007/11926078_65. Retrieved 13 February 2013.
{{cite journal}}: Unknown parameter|coauthors=ignored (|author=suggested) (help)
External links
- Template:Dmoz
- eClinical Forum (eCF)
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