4) Procedure

The following steps outline the procedure for collaborating with external preclinical testing labs:

1. Step 1: Identification of External Testing Labs
   1. Identify and evaluate potential external preclinical testing labs based on their expertise, capabilities, track record, and reputation for quality and reliability.
   2. Review the external lab’s accreditation (e.g., GLP certification, ISO standards) to ensure they comply with relevant regulatory and quality standards.
   3. Engage in discussions with the external lab to assess their capabilities, availability, and costs, ensuring they can meet the study requirements within the project timeline.
2. Step 2: Contractual Agreement
   1. Prepare a formal agreement or contract that outlines the roles, responsibilities, deliverables, timelines, and costs associated with the collaboration.
   2. The agreement should also specify confidentiality agreements, intellectual property considerations, and data ownership rights.
   3. Ensure that the contract includes provisions for regulatory compliance, such as adherence to GLP standards, proper documentation, and audit rights.
3. Step 3: Study Protocol Development
   1. Develop the study protocol in collaboration with the external lab to ensure that all scientific and regulatory requirements are included.
   2. Ensure that the protocol specifies the testing methods, equipment, animal models, sample collection, data collection methods, and reporting requirements.
   3. Review and approve the protocol with the external lab before initiating the study to ensure alignment with the project’s objectives and compliance with internal and regulatory standards.
4. Step 4: Communication and Coordination
   1. Establish regular communication channels with the external lab to monitor study progress, address any issues, and ensure that testing is proceeding as planned.
   2. Coordinate with the external lab to provide necessary materials (e.g., drug candidates, animal models, reagents) and ensure proper storage and handling.
   3. Maintain transparent communication on timelines, deliverables, and any changes to the study protocol or requirements.
5. Step 5: Data Collection and Monitoring
   1. Ensure that the external lab collects and documents data in accordance with the study protocol, GLP standards, and regulatory requirements.
   2. Monitor data collection closely to ensure that results are consistent and reproducible, addressing any discrepancies promptly.
   3. Review interim reports and provide feedback to the external lab as necessary to ensure that data quality is maintained.
6. Step 6: Data Review and Analysis
   1. Upon receipt of the final data from the external lab, review it thoroughly to ensure its accuracy, completeness, and compliance with the study objectives.
   2. Perform data analysis in collaboration with the external lab, if necessary, to interpret the results and determine their relevance to the study and future clinical development.
   3. Ensure that all data is stored securely and that it is available for future use, regulatory submissions, or audits.
7. Step 7: Final Reporting
   1. Prepare a comprehensive study report that includes the objectives, methods, data, analysis, and conclusions from the external lab.
   2. Ensure that the report clearly presents the findings and aligns with the study protocol, addressing any unexpected results or deviations.
   3. Submit the report to relevant stakeholders, including regulatory authorities, and archive it according to GLP standards for future reference.
8. Step 8: Auditing and Review
   1. Conduct periodic audits of the external lab’s work to ensure compliance with the study protocol, GLP standards, and contractual agreements.
   2. Review all records, data, and study reports for accuracy and completeness. Address any discrepancies or deviations and take corrective actions as necessary.
   3. Document all audit findings and corrective actions taken to ensure continuous improvement and compliance with regulatory requirements.
9. Step 9: Sample Disposal
   1. Ensure that all biological samples, chemicals, and laboratory waste generated by the external lab are disposed of in accordance with biosafety and waste disposal regulations.
   2. Ensure that hazardous materials are disposed of in designated biohazard or chemical waste containers to minimize environmental impact.

5) Documents

The following documents should be maintained during the collaboration with external preclinical testing labs:

1. Study Protocols
2. Contractual Agreements
3. Raw Data Logs
4. Interim and Final Reports
5. Audit and Review Records
6. Study Communication Logs
7. Waste Disposal Records

6) Abbreviations

• GLP: Good Laboratory Practices
• FDA: Food and Drug Administration
• QA: Quality Assurance
• IND: Investigational New Drug
• CTD: Common Technical Document

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• OECD Guidelines for Good Laboratory Practice (GLP)
• FDA Guidelines for Preclinical Testing
• ICH E6 Good Clinical Practice Guidelines
• FDA Guidelines for Outsourcing Preclinical Studies

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Collaboration Agreement Template