Clinical research is conducted primarily to determine the safety and efficacy of a new drug or medical device. Poor quality in conducting the clinical trial could mean inaccurate data that could lead to wrong conclusions. It could mean regulatory inspection and noncompliance that will delay time to market. Worse yet, poor quality might harm clinical trial subjects. Clinical trial software available in the market today is designed to help ensure both the quality of the data from the study and the safety of patients participating in the study.
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Regulatory agencies evaluate the conduct of a clinical trial and the data it generates by reviewing all essential documents. The ICH E6 guidance provides a list of essential documents that are required before a clinical trial starts, during the trial, and after a clinical trial. Using clinical trial software can be critical in managing voluminous documentation throughout the clinical research.
The Trial Master File (TMF) contains all essential documents. The contents of a TMF will vary depending on the sponsor. There are typically many contributors to the TMF: the sponsor, CROs hired by the sponsor, and the study's investigators. Robust clinical trial software can serve as a platform for the different stakeholders.
The use of a corrective action and preventive action (CAPA) process is a cornerstone of any quality management system. Likewise, CAPA is critical in ensuring quality in clinical research. Even when a company doesn't have a separate CAPA mechanism, the process is typically incorporated in the quality control and quality assurance processes. When evaluating clinical trial software, choose one that includes a CAPA application.Some companies design their clinical trial systems in a way that differentiates corrective action from preventive action:
A corrective action can be performed without the need for a preventive action. To correct a nonconformance requires performing root-cause analysis of the problem, addressing those root causes, and making sure the corrective action worked. Using clinical trial software provides the added value of making the entire CAPA process visible to the quality manager and the users, making tracking and follow up of CAPA-related tasks easier.
This is meant to avoid a problem that has not occurred yet. Preventive action entails analyzing data to determine the likelihood of the problem occurring, the consequences of the problem, and deciding if the likelihood and the consequences are minimal so as to make them acceptable, or if they are serious enough to require changing the system. When evaluating clinical trial systems, look for one that includes a process that will guide users through every step of the CAPA process.
The MasterControl Clinical Suite™ is a complete clinical trial software solution designed to streamline your processes by managing all documents, tasks, processes, training, relationships, and audits throughout the clinical trial.