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.
Select all the resources you’re interested in downloading
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 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.