Services
TMF Big Challenges
TMF Rescue: If your TMF is in a really bad state with many missing documents, duplicates, misfiled documents and document quality issues, HRM can use their processes designed to ‘rescue’ the situation and produce the best TMF possible.
TMF Due Diligence: Divesting an asset and need to transfer the associated TMFs? Or receiving some TMFs for a divested asset? HRM complete Divestment Due Diligence QCs to help you be assured of the TMF quality prior to transfer.
TMF Amalgamations / Splits: Some protocols are complicated! It is not always an easy decision how to set up the TMF for some protocols and part way through the trial, it dawns on you that two TMFs need to be put together or one TMF needs to be split. Or maybe your TMF is in different locations and needs to be in one or less? Either way, HRM can help with the TMF amalgamation or splitting processes.
TMF Transition: Still have a paper TMF that needs to be transitioned to an electronic TMF (eTMF)? Or need to transfer between eTMFs? Let HRM help you with their seamless process to make what appears to be a difficult task easy and straightforward.
TMF Inspection Readiness
HRM uses its’ Regulatory Inspection Readiness Tracker and study and issue specific storyboards to manage TMF Inspection Readiness (IR). If you are planning to submit a Marketing Authorisation (MA) or a New Drug Application (NDA), it is time to also plan for a regulatory inspection. Using their tried and tested methods, HRM can help you prepare for any GCP inspection.
TMF Quality Improvement
HRM use their TMF QC, audit and ‘Hot Spot’ analysis techniques to identify, using a risk based approach, where the issues are in the TMF. HRM can then work with the Trial Team to ensure that the findings are resolved and in turn help to ensure that the final result is a healthy, up to date TMF.
TMF Management
TMF Process: No TMF Standard Operating Procedures (SOPs) or policy documents or need an update? Let HRM provide you with fit for purpose processes to enable your TMFs to be a success.
TMF Strategy: HRM provides both strategic and specific advice, including risk based approach advice. Please contact HRM, so we can discuss your requirements.
TMF Training: HRM provides extensive TMF training to individuals (Train the Trainer), small and large groups, online and face to face. HRM provides standard and bespoke training courses.
TMF and ISF Archive Management: Maybe you think that setting the TMF to ‘archive’ in the eTMF is sufficient? But let’s talk about longevity of file formats. If you want to actively manage your archive TMFs to ensure that documents can be accessed and read for their full retention period, HRM can help. For Investigator Site Files (ISFs), most of which are still in paper, HRM has a archive management process which removes the sponsor from direct contact with the ISF archive provider and manages requests from sites regarding the destruction of their stored ISFs.
For more information about Hedian Records Management and how our services can help your business or for a free no-obligation initial meeting, please contact us at info@hedianrm.com.
