"The sponsor should implement a system to manage quality throughout all stages of the trial process...The quality of a clinical trial should be designed into the study and should rely on prospective, multidisciplinary planning of important factors that influence the quality of the study. " -ICH E6(R3) 5.0

Services

Need expert clinical trial TMF consulting? Whether you require eTMF implementation support or TMF process improvement services, ICE Consulting is here to help. Contact us today!

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TMF Management

A well-managed TMF isn’t just about compliance—it’s about efficiency. We provide support to ensure your TMF (paper or electronic) is organized, complete, and always inspection ready.

TMF Completeness Review

Is your TMF missing key documents? We conduct thorough assessments to identify gaps and provide a plan for getting everything in order before it becomes a problem.

Sponsor Oversight Review

Sponsors are responsible for ensuring trials are conducted properly—but are you meeting your obligations? According to ICH E6(R3), Section 5.2.2:

"The sponsor remains responsible for the oversight of any trial-related duties and functions that are subcontracted to a CRO or other third party. The ultimate responsibility for ensuring compliance with applicable regulatory requirements and GCP standards cannot be delegated."

In practice, oversight is increasingly being placed on functional leads rather than a dedicated TMF team. While this shift aligns with industry trends, functional leads are not always TMF experts, which can introduce compliance risks. We help bridge that gap by training functional teams on best practices for TMF oversight—equipping them with the knowledge and tools needed to maintain compliance while managing their day-to-day responsibilities.

TMF Vendor Oversight & Compliance Monitoring

You rely on vendors to get things done, but are they meeting expectations? We help monitor vendor performance, ensuring they’re compliant with regulations, contracts, and quality standards—so you can avoid costly surprises down the road.

Process Development

We work with you to create practical, scalable processes tailored to your organization’s needs. Whether you’re building from scratch or refining what’s already in place, we focus on efficiency, compliance, and making your workflows easier to manage.

eTMF Implementation

We make eTMF implementation smoother by helping you transition to an electronic Trial Master File (eTMF) with ease. Our approach ensures your clinical trial document management stays aligned with GCP compliance and regulatory standards—without the headaches.

Process Implementation

New processes only work if people actually follow them. We help implement changes in a way that makes sense for your team—offering training, hands-on support, and real-world solutions to make adoption smoother.

GAP Assessment

Not sure where the gaps are? We’ll take a deep dive into your processes, documentation, and compliance strategies to identify what’s missing and what needs improvement. Then, we’ll give you a clear, actionable plan to close those gaps.

Inspection Readiness Review

No one likes scrambling before an audit. We help you get ahead by reviewing your clinical trial documentation to ensure you’re ready for an inspection—without the last-minute stress.

Compliance Check: Are You Following Your Own Processes?

Having processes in place is one thing—making sure they’re actually being followed is another. We review your existing workflows to identify inconsistencies, risks, or areas where teams may be deviating from the plan. Our goal is to help you stay compliant with the processes you already have, so you’re always prepared when questions arise.

Disaster Recovery

Sometimes things don’t go as planned—maybe your TMF is incomplete, out of compliance, or just plain messy due to CRO mismanagement or internal challenges. We step in to assess the situation, create a remediation plan, and, if needed, take action to get your TMF back on track. Whether it’s filling gaps, correcting inconsistencies, or implementing better oversight moving forward, we help ensure your TMF is in good shape and inspection ready.

Paper TMF Review

If you're still dealing with a paper Trial Master File (TMF), we’ll make sure it’s complete, accurate, and compliant. We’ll also help you strategize for a smoother transition to digital if that’s in your future.

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