The adoption of digital solutions is becoming commonplace due to the increased efficiencies of electronic solutions in maintaining compliance in clinical trials. In this blog post, we’ll explore the critical components of going digital with
In March 2023, the FDA issued an update to its Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Draft Guidance, reflecting the agency’s acknowledgement of the advancing use of electronic
Are your clinical trials ready for an audit, inspection and/or site monitoring visit now? If your organization is running clinical trials, you know that being audit ready is essential to meet Good Clinical Practice (GCP)
Clinical trial inspections, monitoring visits, and audits are all important quality assurance measures that are used to ensure the integrity of clinical trials. However, there are some key differences between these three activities that are
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