Modern and Real-World Study Oversight with myClin
Abstract: The term “Sponsor Oversight” has slowly crept into the vernacular of Clinical Research and Development but, make no mistake, the requirement for Oversight is all around us. The Medicines and Healthcare Products Regulatory Agency (MHRA) Guide to GCP makes no fewer than 169 references to “oversight”. The call for documentation or evidence is a consistent and repeated theme across many regulatory publications. The updated ICH E6 (R2) Addendum, adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last year, reinforces this trend.
This paper provides a modern definition of oversight and what it involves, and illustrates how the myClin platform builds a strong oversight directly within your study team communication and collaboration channels.
- The Reality of Oversight as a GCP Requirement
- Principles of Oversight and Common Inspection Findings
- Streamline, Centralize and Automate Oversight
- The Trial Master File as the Stream of Consciousness for your Studies
- myClin’s Role in Quality Management
myClin is the leading Clinical Trial Knowledge Platform, offering a transformative collaboration channel and the most documented, data-driven clinical trial oversight.
The company's mission is to leverage technology to enhance participation, engagement, collaboration, and compliance in clinical trials.
The team of clinical research veterans that created myClin in 2008 brought deep experience delivering clinical operations services and building feature-rich eClinical systems. Since then, myClin has been used across all phases of research, in global bio-pharmaceutical and device studies with thousands of clinical users.
myClin is headquartered in Philadelphia, PA, with offices in San Francisco, CA, and the UK.