Our company acts as intermediate between the Client and the Laboratories where the required scientific studies are undertaken. ENC helps you generate the right study.
Regulatory studies fulfill the relevant regulatory requirements and must be carried out in accordance with the recommended guidelines. They either describe a property of an active substance or product, generate usable endpoint for the risk assessment, or provide higher tier refinement.
A study that does not meet high quality standards can be rejected by the regulatory authorities with dramatic consequences for current and future products registrations.
Study monitoring follows a comprehensive process.
- Determining study objective and requirement.
- Finding suitable laboratory candidates.
- Requiring quotes.
- Comparing quotes.
- Choosing final option.
- Requiring a draft study plan.
- Comparing the plan with requirements and guidelines.
- Adapting the plan to specific needs.
- Following up of updates and finalisation.
- Following up relevant interim result.
- When necessary, asking for corrections or additional experimentation.
- Giving a proper orientation to the study.
- Providing technical support to solve the problems arising during the study.
- Assessing and commenting the draft report, making sure that the final report will be complete and of quality.
- Providing advice for improving the report.
- Checking the adequacy of the statistical methods.
- Ensuring that results are adequately formatted for regulatory purpose.
During the whole process
- Communicating the relevant information to the sponsor.
- Following up study plan amendments if necessary.
- Asking for interim report if necessary.
- Meeting the deadline.