Documentation & Compliance Management
Your clinical trial’s central archive always audit-ready!
The Regulatory Binder
Is the cornerstone of every successful clinical trial, ensuring your study is compliant, audit-ready, and meticulously organized. At Kernel, we simplify regulatory documentation, providing comprehensive, inspection-ready solutions that keep your trial on track from start to finish.
Our Expert Regulatory team has extensive experience in global submissions, leveraging strong connections with SFDA (Saudi FDA), Egyptian and UAE health authorities, as well as other global regulators, to streamline approvals and eliminate regulatory roadblocks.
Regulatory Compliance & Submission Support
- Ensuring full adherence to JFDA, FDA, EMA, ICH-GCP, and global regulatory standards
- Handling sponsor and site communication for regulatory submissions
Post-Trial Documentation & Archiving
- Final trial reports, audit certificates, investigational drug record
- Secure storage of essential trial documents by regulatory retention policies
Our Comprehensive Documentation Services Include
Ongoing Trial Documentation
[Amendments, screening logs, informed consents, safety reports]
- Protocol amendments, subject screening & enrollment logs
- Signed informed consent forms, drug accountability records
- Safety reports (e.g., adverse event documentation, SAE reporting)
Pre-Trial Regulatory Setup
Protocol, Investigator’s Brochure, ICFs, IRB/Ethics submissions
- Study Protocol, Investigator’s Brochure, Informed Consent Forms (ICFs)
- Regulatory Approvals (e.g., IRB, Ethics Committees, FDA)
- Investigator credentials, financial disclosures, & agreements
Let’s make your clinical trial audit-ready and stress-free.
Reach out to Kernel CRO for end-to-end documentation and compliance management.