We are Trial Master File subject matter experts who are passionate about the TMF because we know how important it is to the clinical trial process. We believe the effort and time put into creating and maintaining a healthy TMF will always be worth it.

Who is ICE Consulting?

At ICE Consulting, we specialize in Trial Master File (TMF) strategy, management, and compliance, providing tailored support to sponsors at every stage of their TMF journey. While Suzanne personally leads each engagement, she also collaborates with a network of highly experienced TMF professionals who bring additional expertise in inspection readiness, document management, training, and TMF vendor oversight.

Our flexible approach allows us to scale support as needed—whether for short-term projects, system transitions, or ongoing TMF oversight. Each consultant we work with has extensive experience in sponsor and CRO environments, ensuring that every project benefits from real-world TMF expertise and best practices.

At ICE Consulting, our focus is on practical solutions that make a difference, ensuring that sponsors stay inspection-ready and confident in their TMF compliance.

Suzanne Turner | Founder & CEO

I am a Trial Master File (TMF) Subject Matter Expert dedicated to helping sponsors optimize TMF management, streamline processes, and ensure compliance. With over 12 years of experience, I’ve supported teams in maintaining inspection readiness, implementing best practices, and navigating the evolving TMF landscape. I also contribute to industry initiatives as a CDISC TMF Volunteer.

My career began at a large CRO, where I gained hands-on experience managing full paper TMFs—building a deep understanding of document structures and regulatory expectations. As the industry transitioned to electronic TMFs, I became a TMF Subject Matter Expert, guiding trial teams through this shift and leading training efforts. Before moving into consulting, I was a Manager in the Document Management department, further strengthening my expertise in TMF oversight and compliance.

I later joined a consulting firm specializing in TMF health and inspection readiness, where I expanded my knowledge while mentoring and onboarding new team members. In 2023, I launched ICE Consulting to work directly with sponsors, particularly smaller companies that benefit from tailored TMF solutions and hands-on support.

I’m passionate about TMF process development and implementation, training, functional management, and vendor oversight. I enjoy collaborating with teams to create efficient TMF strategies that align with regulatory expectations—ensuring sponsors feel confident in their compliance and audit readiness.

Page updated

Google Sites

Report abuse