Voisin Consulting Life Sciences office page icon
By Stage of Drug Development

Early-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

Assess efficacy, effectiveness and safety, and gather data for registration and market access.

Early clinical development initiates testing in humans, corresponding to Phases 1 and 2a exploratory studies. The investigational product is administered to small groups of healthy volunteers or patients to assess safety and to determine a safe dosing range. A clinical safety system is established to monitor the product’s safety profile and assess significant findings for reporting to regulatory authorities.

Concomitantly, subsequent trials are outlined and readied. Safety, clinical endpoints, patient populations, biomarkers and relevance of comparators are the principal topics of scientific advice meetings with regulators at this stage. Reimbursement environment analysis is undertaken in order to begin to apprehend reimbursement or access challenges, current perceptions of standard of care, defining unmet need and typical treatment pathways. Manufacturing processes are scaled up to provide sufficient drug product for larger clinical trials.

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

  • Should healthy volunteers or patients be recruited for Phase 1?
  • What will be the market access roadmap?
  • Does the development plan fit with Regulators’ and HTA’s evidence requirements?
  • What are the costs and timelines to complete the program?
  • Is the dose-range finding plan in Phase 1/2a studies adequate to identify the optimal dose for pivotal studies?
  • Is a pediatric development plan necessary? What is the right time for this?
  • When and how to scale-up manufacturing processes?
  • Is all the CMC information available to assemble the IMPD?

Our Mission

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

Advance with us

What VCLS Can Do

What VCLS Can Do - Services

VCLS Expertise