Helping Biotechnology and pharmaceutical Companies Achieve Inspection Confidence
Hedian, the senior led specialist Trial Master File (TMF) consultancy, offers practical TMF expertise, independent advice and end to end records lifecycle support for clinical phase, biotechnology, pharmaceutical, and medical device organizations globally.
Notably, Hedian provides specialist assistance to companies with limited or no TMF support.
For further information on our services and how we can assist you in creating high quality, inspection ready TMFs, do not hesitate to get in touch.
Problems Hedian Solves
Is your TMF Creating Risk?
That might be the case if you have any of these challenges:
- Inspection readiness concerns
- Missing or incomplete TMF documentation
- CRO oversight challenges
- Inconsistent TMF processes
- Delayed filing
- Legacy remediation projects
- eTMF transfers and migrations
- Archiving and retention uncertainty
We help organizations reduce compliance risk, improve TMF quality and build confidence before inspections occur.
TMF Services
Delve into the services below and contact us to find out how we can help you to have quality, inspection ready TMFs
TMF Health Checks
Understand the true health of your TMF.
Hedian identifies quality issues and compliance risks before they become inspection findings.
We use our quality risk based techniques to identify these issues and work with the Trial Team to ensure that the findings are resolved to help create a healthy, up to date ‘inspection steady’ TMF.
TMF Inspection Readiness
Prepare for inspections with confidence.
We help sponsors asses TMF quality, remediate deficiencies and strengthen inspection readiness before regulatory scrutiny occurs.
TMF Governance & CRO Oversight
Having effective and streamlined TMF processes helps you deliver results accurately and fast.
Let us use our skills to improve the governance and oversight of your TMFs:
- Governance frameworks
- Oversight models
- CRO performance reviews
TMF Training & Advisory
Hedian can help your organization build internal TMF capabilities through training and practical advise.
Hedian specialize in :
- Bespoke training based on extensive knowledge
- A variety of training delivery formats including interactive modules
- Strategic and detailed advice to suit any TMF situation
TMF & ISF Archiving
Hedian supports TMFs through their entire lifecycle, including at the last stage of archiving and, eventually, certified destruction.
Hedian specializes in archive governance, investigator site archive management and retention strategies.
About Hedian Records Management
Hedian, located in the Royal Borough of Windsor and Maidenhead, near London in the UK, was set up by Sarah Hitching in 2019, to provide TMF services mainly to the pharmaceutical, biotechnology and clinical phase companies.
Get in touch
Whether you need an independent TMF assessment, inspection readiness support, remediation expertise or archiving guidance, Hedian can help.
We offer a free no obligation initial meeting.