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Solutions for Each Stage of Development
From preclinical through to commercialization.
Our team’s integrated specialist skills enable to address current challenges, while
preparing for next steps along the product timeline.

Late-stage clinical development primarily aims at demonstrating efficacy, safety and cost-effectiveness, and 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. Read More

VCLS Solutions

Setup and manage clinical trials

  • Develop essential documents (protocol, IND/IMPD, IB, consent forms)
  • Assemble and submit IND/CTA packages tailored to local requirements, obtain approval from regulatory authorities to conduct studies (coordinate international regulatory processes)
  • Oversee execution and ensure regulatory compliance of clinical trials (protocol, IB amendments)
Manage safety cases, adapt clinical safety system to post-market pharmacovigilance setting

  • Manage and report safety cases (expedited & periodic reporting)
  • Monitor product safety profile, organize DSMBs or clinical expert panels
  • Draft development risk management plan
  • Anticipate the adaptation of the clinical safety system and database to a post-marketing pharmacovigilance setting
Establish early access programs (US expanded access / EU compassionate use)

  • Assess opportunities to generate pre-NDA/BLA/MAA awareness and, potentially, revenue
  • Design and implement named-patient or cohort expanded access /compassionate use programs (design protocols for therapeutic use, obtain approval from regulatory authorities, ensure product distribution, fulfill safety reporting obligations)
De-risk clinical development and filing

  • Organize regulatory and Health Technology Assessment (HTA) expert panels
  • Discuss plans with regulators and payers – jointly or separately
  • Design phase 3 to accommodate regulatory and HTA requirements
  • Companion diagnostic and/or delivery system validation / approval
  • Address pediatric development requirements
Anticipate commercial production and launch

  • Select manufacturer as needed
  • Transfer manufacturing sites (demonstrate comparability)
  • Upscale and prepare stock
  • Complete process and method validation
  • Generate ICH stability studies representative of commercial process (primary batches)
  • Prepare IMPD
Define market access strategy, develop value proposition for payers
  • Understand price and reimbursement levels relative to product value
  • Gather evidence for negotiating with payers
  • Develop value proposition and value message
  • Refine and finalize economic models
  • Engage reimbursement authorities
  • Develop core payer value dossier
  • Assess impact of product labels on pricing and market access





























The main objective of late-stage clinical development is to evaluate the medical device risk/benefit balance during pivotal clinical studies and hence further substantiate the labeling claims. The product is tested in larger patient populations, and ideally compared with the therapeutic gold standard or direct competitor. Read More

VCLS Solutions

Setup and manage clinical studies

  • Prepare essential documentation (e.g. protocol, Investigator Brochure)
  • Assemble and submit CTA packages tailored to local requirements, obtain approval from international regulatory authorities to conduct clinical trials
  • Oversee execution and ensure regulatory compliance of clinical trials
Manage safety cases

  • Manage and report safety cases
  • Anticipate the adaptation of the vigilance system to commercial-stage requirements
Detail the market access strategy, develop a value proposition for payers

  • Understand price and reimbursement levels relative to product value
  • Gather evidence for negotiating with payers
  • Develop value proposition and value message
  • Refine and finalize economic models
  • Engage reimbursement authorities
  • Develop core payer value dossier
  • Assess impact of product labels on pricing and market access