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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.

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. Read More

VCLS Solutions

Define clinical development strategy
  • Extrapolate animal data to humans for designing clinical protocols (including drug schedule, route of administration, subject/patient follow-up)
  • Outline clinical development up to marketing, with for each trial: synopsis, endpoint(s) and surrogate marker(s), patient populations, designs, study feasibility in the targeted countries
  • Organize clinical advisory board
  • Design development plan for companion diagnostic and/or delivery device
  • Identify opportunities for early access (US expanded access / EU compassionate use programs)
  • Anticipate process transfer if needed and manufacturing campaign
  • Anticipate product release (identify testing labs, methods needed)
Communicate with regulators and payers

  • Obtain regulators’ input on manufacturing plan, analytical testing, nonclinical and clinical development, regulatory strategy, (Scientific Advice/Protocol assistance, Pre-IND meetings, End-of-Phase 1 meeting, End-of-Phase 2 meeting, parallel advice)
  • Obtain clinical trial approval from US FDA and Institutional Review Boards, EU Competent Authorities and Ethics Committees (Investigational New Drug applications, Clinical Trial Applications, respectively)
  • Obtain feedback from payers – possibly jointly with regulators – on late-stage clinical design
Develop clinical trial essential documents

  • Develop IND / CTA, Investigational Medicinal Product Dossier, protocol, Case Report Forms (CRFs) Informed Consent Forms and Investigator Brochure(s)
  • Assemble and submit IND / CTA packages
Ensure regulatory compliance of clinical trials

  • Protocol amendments
  • Interim data analysis
  • Execution and audit of clinical trial
Establish clinical safety systems, report and monitor safety cases

  • Set up a lean clinical safety system, that will accommodate clinical-stage requirements and adapt to a post-marketing pharmacovigilance setting in full compliance with ICH, US and EU requirements
  • Manage and report safety cases (expedited and periodic reporting)
  • Monitor safety profile, organize Data Safety Monitoring Boards (DSMB)
Refine manufacturing process and analytical methods requirements

  • Provide support and recommendations for scale-up of manufacturing processes, integrate Quality-by-Design (QbD) potential
  • Drug product formulation development
  • Product characterization, specifications, and associated analytical methods
  • Support process and method transfer, scale-up of manufacturing processes and design of comparability strategy
  • Design quality and GMP compliance (drug substance and drug product, from suppliers to product release, through analytical laboratories)
  • Collect stability data
  • Prepare for audits and GMP inspections
Explore competitive and reimbursement landscapes

  • Define the burden of illness
  • Scan and anticipate competitive environment
  • Outline economic models
  • Ensure that clinical trials address payers requirements





























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. Read More

VCLS Solutions

Define clinical development strategy

  • Identify relevant regulatory requirements and clinical guidelines
  • Conduct a scientific literature review
  • Anticipate critical clinical differences with similar products
  • Define the adequate safety and efficacy/performance claims
  • Outline clinical development up to marketing
Develop clinical trial essential documents
  • Prepare essential documentation (e.g. protocol, Investigator Brochure)
  • Assemble and submit international Clinical Trial Application packages
Communicate with regulators

  • Obtain regulator’s inputs on clinical development
  • Obtain approval to conduct clinical trials from regulators and Ethics Committees / IRBs
Ensure regulatory compliance of clinical trials

  • Manage protocol amendments
  • Execute and audit clinical trials
Establish a vigilances system, report and monitor safety cases

  • Set up a vigilance system
  • Manage and report safety cases
Explore competitive & reimbursement landscapes

  • Define the burden of illness
  • Scan and anticipate competitive environment
  • Outline economic models
  • Ensure that clinical trials address payers requirements