Clinical Trial Software System
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A Clinical Trial Software System is a clinical research software system that can support clinical trial processes.
- Context:
- It can be based on a Clinical Trial Platform.
- It can range from being a Centralized Clinical Trial Software System to being a Decentralized Clinical Trial Software System.
- It can support one or more Clinical Trial Stages,
- such as: assist with study design and protocol development.
- It can facilitate patient enrollment and randomization.
- It can enable electronic data capture and management
- It can support regulatory compliance and audit readiness.
- It can provide real-time study metrics and reporting
- It can facilitate collaboration among study stakeholders.
- It can include:
- a CTMS, such as one built on
Force.com. - an EDC, such as one built on Veeva.
- an eCOA System, such as one build on Medable, Medidata, Signant.
- a Clinical Data Repository (CDR), such as one by Saama Systems.
- a Study Start Up (SSU), such as one by Veeva.
- a CTMS, such as one built on
- …
- Example(s):
- Counter-Example(s):
- …
- See: Decentralization, Clinical Trial, Decentralized Computing, Telemedicine.
References
2023
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- A Clinical Trial Software System is a software system designed to support clinical trial processes, such as data management, patient recruitment, and reporting.
Some characteristics of a Clinical Trial Software System are:
- It can assist with study design and protocol development.
- It can facilitate patient enrollment and randomization.
- It can enable electronic data capture and management
- It can support regulatory compliance and audit readiness.
- It can provide real-time study metrics and reporting
- It can facilitate collaboration among study stakeholders.
- Some related concepts to Clinical Trial Software Systems are:
- Electronic Data Capture (EDC) systems
- Clinical Trial Management Systems (CTMS)
- Randomization and Trial Supply Management (RTSM) systems
- Electronic Patient-Reported Outcomes (ePRO) systems
- Clinical Data Warehousing and Business Intelligence (CDW/BI) systems
- Regulatory compliance and reporting tools.
- A Clinical Trial Software System is a software system designed to support clinical trial processes, such as data management, patient recruitment, and reporting.