Use our experience to improve your TMF Inspection Readiness
Hedian’s expertise can help with all your TMF Inspection Readiness needs. Whatever the format, we can help you identify and remediate the risks in your TMFs.
To find out more about TMF Inspection Readiness, please see below.
When to Start TMF Inspection Readiness
If you are planning to submit a Marketing Authorization (MA) or a New Drug Application (NDA), it is also time to make sure that all relevant TMFs are inspection ready. It is ideal to start preparations at least 6-12 months before you think the inspection might happen. Or maybe you are due a routine inspection where the inspectors could look at a variety of trials and their corresponding TMFs. As soon as this possibility is identified, TMF Inspection Readiness should start.
How Hedian Can Help
Either way, if you need help, Hedian can provide Inspection Readiness expertise to make sure your TMFs are ready. We will use our tried and tested methods to help you prepare for any Good Clinical Practice (GCP) Inspection.
The Hedian Tracker
Hedian’s Regulatory Inspection Readiness Tracker is used to check whether your TMF is fit for an Inspection. The tracker is used to identify the risks and formulate resolutions, as well as track these to completion.
In addition, if specific complex issues are identified, Hedian will capture each one in a ‘storyboard’. The storyboard captures key events, processes, decisions, outcomes and resolutions and is used to enhance clarity of each situation.
Find out More about our Other services
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Get in touch
If you are interested in using Hedian to help with Inspection Readiness aspects of your TMF, then please get in touch.
Get in touch to arrange your free, no obligation initial meeting.