Evaluation of biocompatibility and safety. Analytical validation.
Early clinical development is primarily composed of human proof of principle/pilot clinical studies – to confirm feasibility in human, explore patient populations and performance claims. Concomitantly, subsequent clinical trials are outlined and prepared for. The appropriateness of the clinical development plan is confirmed during strategic consultations with regulatory authorities/bodies.
Reimbursement environment analysis is undertaken in order to begin understanding any market access challenges, current perceptions of standard of care, defining unmet need and gold standard treatments as well as other treatment alternatives.
Design and conduct pre-clinical studies
Conduct a scientific literature review.
Anticipate critical clinical differences with similar products.
Design product and establish technical documentation file
Prepare essential documentation (e.g. protocol, Investigator Brochure).
Assemble and submit international Clinical Trial Application packages.
Generate required evidence for regulatory approval & market access (HTA, pricing & reimbursement)
Identify relevant regulatory requirements and clinical guidelines.
Ensure regulatory compliance of clinical trials.
- Where’s the best to conduct the study?
- What are the HTA evidence requirements?
- Costs & time to complete the study?
- What market share can be expected?
- What will be the market access roadmap and the key stakeholders to address?
- What are the appropriate funding and supply channels?
- Does the development plan fit with Regulators’ and HTA’s evidence requirements?
- When & how to scale-up manufacturing processes?
- Product Development Design Review?
- Quality Management System audits?