TMF Management and Process Planning

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LMK Clinical Research Consulting specializes in document and TMF management of clinical trials. No project is too big or small for us. We are flexible and offer a full range of document services from SOP development through file archive. Our team will work with you throughout the life cycle of your project to effectively plan, collect, and maintain your clinical trial documents on an ongoing basis. If you need help implementing an eTMF from paper or migrating from one eTMF system to another, our highly skilled consultants are ready to assist.

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TMF Project Manager Resourcing

We offer you highly experienced Project Managers who are not only TMF experts, but also have extensive knowledge in clinical trial drug development. Our employees act as part of your study team providing guidance as subject matter experts in TMF process management ensuring compliance to guarantee quality deliverables.

Process Planning and SOP Development

Following standard processes are critical to effectively work within the TMF. If your company is new to clinical trial document management, we can help you develop processes, strategies and procedures to manage and store your documentation.

Metrics Development

Tracking metrics and confirming that the targets are maintained are essential to measure TMF health. Metrics can also define TMF quality and identify defects. LMK provides our clients with a metrics program that will measure quality in a variety of ways including by Therapeutic Area/Compound, Study, Functional Line and Document Type.