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By Stage of Drug Development

Late-Stage Clinical Development

Pre-Clinical Development Determine the safe dose for FIH study Early-Stage Clinical Development Assess efficacy, effectiveness and safety Late-Stage Clinical Development Gather data for registration and market access Registration Assemble and file an application Commercialization & Post-Launch Post-approval regulatory, lifecycle management

Late-stage clinical development primarily aims at demonstrating efficacy, safety, and cost-effectiveness. It corresponds to Phases 2b and 3 confirmatory studies. The product is tested in larger clinical studies, often as compared with the therapeutic ‘gold standard’ or standard-of-care (SoC), if any. The collection of safety data on a larger scale enables the confirmation of the product’s safety profile.

Phase 3 trials are conducted in a large number of countries in view of supporting approval in broader markets. Health economics data are also gathered to demonstrate the product’s value to payers and support post-approval reimbursement.

Client Goals

Non clinical and clinical developement

Design and conduct clinical trials

Define clinical development strategy.

Outline clinical development up to marketing, with for each trial.

Regulatory strategy and submission

Generate required evidence for regulatory approval & market access (HTA, pricing & reimbursement)

Develop clinical trial essential documents.

Ensure regulatory compliance of clinical trials.

Stage of development: challenges

Challenges

  • Is(are) the planned pivotal study(ies) adequate to support both registration and positive HTA appraisal?
  • How to obtain endorsement from regulators and HTA on the late-stage clinical development strategy?
  • How to measure health care resource use associated with the disease?
  • How to articulate a development plan across multiple regions, with potentially different requirements?
  • How to confirm/improve the product’s benefit/risk ratio?
  • Which clinical endpoints would address both regulators’ and payers’ requirements?
  • How can disease awareness be optimized?
  • What must be done for launch readiness?
  • How to validate manufacturing processes and methods?
  • How to design/ adapt manufacturing for commercial launch (upscaling)?
  • Which post-launch evidence will the payers require?
  • Are there any early access opportunities?

Our mission

Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets.

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