Use our experience to improve your TMF Quality
If you have concerns about the quality of your TMFs, in particular for key and pivotal studies, it might be time to get some help. Hedian has extensive experience of TMF Health Checks for all types and phases of studies, including how to apply a risk based approach. Read on to find out how we can help you.
TMF Health Checks
Hedian use their TMF Quality Control (QC), audit and ‘Hot Spot’ analysis processes to identify where the issues are in the TMF. The process uses the approaches outlined in ICH Guideline for Good Clinical Practice (GCP) E6 R3, the CDISC TMF Risk White Paper and Tool (click on ‘TMF Resources’, then ‘Risk’) and experience gained from many years of working with TMFs.
Once the key issues are identified, Hedian work with the Trial Team to ensure that the findings are resolved effectively and pragmatically to help produce a healthy and up to date TMF. Read on below to find out more information about these processes:
TMF Quality Control (QC)
Hedian’s TMF QC Checklist is flexible and can be applied to any TMF. The risk based approach can be adapted to suit you, the trial type and the specific circumstances. Experienced Hedian TMF Leads apply the process for each TMF and provide you with the results. The TMF Lead also work closely with the Trial Team to remediate the findings and help keep the process on track.
TMF ‘Hot Spot’ Analysis
Perhaps a TMF QC is too detailed for your purposes or a TMF Audit not in depth enough. If so, you might need a TMF ‘Hot Spot’ Analysis where the key areas of the TMF are reviewed and major areas of risk are highlighted.
TMF Remediation
Whether addressing legacy studies, preparing for submission or an inspection, or resolving audit findings, we provide practical remediation support tailored to your operational environment.
TMF Audit
In most cases, a TMF should have at least one audit. Audit is the chance for a non Trial Team member to complete an objective review of the TMF contents. Hedian’s auditors will review your TMF and provide the Audit Report detailing the issues found and an Audit Certificate for filing in the TMF. Using experienced TMF Leads, Hedian help you and the Trial Team resolve the audit findings and so help improve the quality of your TMF.
Find out More about our Other services
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Get in touch
If you are interested in using Hedian to help the quality management aspects of your TMF, then please get in touch.
We offer a free no obligation initial meeting, please contact us.