In-Demand Services
In-Demand Projects
The Services our Partners Rely on Most
These are the services we’re delivering most often for our partners—because this is where clinical trial sponsors who prioritize compliance are focused.
Who are our Partners?
We work with pharmaceutical, biotech, and medical device trial sponsors, with a strong focus on emerging, small, and mid-sized organizations, while also supporting larger sponsors with targeted solutions for high-priority needs—especially those who are:
- Implementing or optimizing eClinical systems
- Working under Fast Track or Breakthrough designation
- Launching pivotal studies with planned regulatory submission
- Preparing for upcoming regulatory inspections
eTMF Story of the Study
We’ll conduct a targeted review of TMF documentation to identify inconsistencies between the study plan requirements and TMF content, gaps against relevant Study Plans, SOPs, regulations, and best practices, as well as any systemic gaps or potential risk areas. You’ll receive a comprehensive report outlining identified issues along with actionable recommendations, giving you the confidence and peace of mind that your TMF is compliant and inspection-ready.
eClinical System Optimization
We’ll assess your current eClinical systems to define an ideal future state for compliance. From there, we’ll develop a strategic plan to bridge the gap, including a comprehensive analysis of current system functionality and process capabilities, a comparative assessment of the current state versus the desired future state, a detailed action roadmap to achieve compliance, and dedicated support for implementation and remediation.
GCP Gap Assessment
We’ll conduct a focused review of study procedural documents, related materials, and operational workflows to assess your current GCP operating environment. This includes a high-level evaluation of TMF content and benchmarking the review against regulations and industry best practices. You’ll receive a prioritized list of compliance and efficiency gaps, along with actionable remediation recommendations. With our expertise, we know where to look and what to look for—helping you address smaller issues now before they escalate into costly challenges later.
Let Us Empower You With Confidence
