Use our experience to Manage your GCP Archiving
Whether paper or electronic, Hedian can help with archive management of your TMFs and ISFs. Read on to find out more about Archive Governance, ISF Management and Retention Strategies and how Hedian can help.
Archive Governance
Hedian puts in place clear policies, procedures and responsibilities to ensure TMFs and ISFs are archived appropriately. This governance ensures that GCP documents are archived and managed in accordance with regulatory requirements and organizational standards. It is important that governance is in place throughout the retention period. In particular, there are specific requirements for the long term data preservation of electronic records.
Hedian’s Archive Governance provides oversight of archive providers, retention schedules, access controls, retrieval processes and records lifecycle management. This helps organizations reduce compliance risk and maintain long term access to TMFs and ISFs in line with regulatory requirements.
Hedian can provide client specific archive governance procedural documents to ensure your company is compliant.
Investigator Site File (ISF) Archive Management
Hedian supports the compliant management of ISFs during final archiving, the retention period and certified destruction.
Our services include site, archive storage provider and retention period management. It also includes transfer and retrieval of ISFs and final destruction in line with regulatory expectations for long term ISF retention.
Retention Strategies
Clear, compliant retention strategies are required to ensure TMFs and ISFs are retained for the appropriate period. The retention periods must be in accordance with applicable regulations, contractual obligations and organizational requirements.
We help organizations navigate complex global retention requirements, establish defensible retention schedules, and implement governance processes that support compliant record preservation, retrieval and eventual compliant destruction.
Find out More about our Other services
As well as TMF & ISF Archiving, Hedian provide services such as TMF Governance & CRO Oversight, TMF Training and Advisory, TMF Health Checks and TMF Inspection Readiness. Click on the buttons below to find out more:
Get in touch
If you are interested in using Hedian to help with your TMF challenges, then please get in touch.
We offer a free no obligation initial meeting, please contact us.