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Remediation and Document Management Services for Sponsor

Situation:

A late stage biopharmaceutical company working on a fast-tracked Phase 3 study was providing their own document management and recently partnered with an eTMF solution provider to manage their eTMF. Due to eTMF platform constraints and lack of TMF training/awareness, the company found themselves at risk of FDA non-compliance. With over 4000 backlogged documents and an overwhelmed and underprepared staff, LMK Clinical Research Consulting was contacted to help mitigate the backlog of collected trial documents and ensure continued inspection readiness.

LMK Solution:

  1. Create a sustainable TMF Plan and guidance documentation for accurately filing documents into the TMF.
  2. Assess and develop beneficial eTMF workflows and training.
  3. Devise a plan to resolve their 4,000+ document backlog of collected trial documents, and execute timely.
  4. Provide onsite TMF University classes to prevent repeated TMF mismanagement and FDA non-compliance.
  5. Provide expert document management services from LMK’s experienced and trained employees to ensure a contemporaneous TMF.

Outcome

LMK successfully created a custom TMF Plan, inclusive of QC guidance, classification and naming convention for all documents, and delivered customized, detailed TMF training to the company. As a eTMF agnostic company well versed in the client’s eTMF system, LMK developed trainings/workflows specifically tailored to their subscribed eTMF features. LMK’s expert team also addressed and promptly uploaded, QC’d, named, and classified the 4,000+ document backlog.

Since the remediation of the document backlog and creation of sustainable workflows, LMK has successfully managed and maintained a contemporaneous and inspection ready TMF. Allowing LMK to provide document management services has efficiently provided the client with a non-biased review of document QC, TMF expertise, improved workflow and processes, TMF training, and a compliant TMF.

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