Clinical development

Design and careful planning helps you conduct your clinical studies efficiently. We have 20 years of experience in creating lean clinical development programs to generate missing clinical evidence for registration of Gx and Value Added Medicines and have gained considerable expertise in it.

Our study designs do reflect the status of pharmaceutical development, published data and product complexity. We have access to a panel of reliable CROs, which assures timely and effective study execution. Upon sponsor’s request we can also provide monitoring and auditing services that are in accordance with both GCP and GLP.

Synavia offers the following services

  • Clinical development strategy/conceptualization, hypothesis, milestones definition and evaluation, feasibility studies
  • Clinical Trial Protocol development and adjustment: Proposal of study population sample size, sample size optimization AND variability estimations
  • Inhalation drug product development
  • Pharmacokinetic expertise and statistics, data mining, root cause analysis of unsuccessful development
  • Cost effective solutions and risk analysis:
    • CRO tendering and risk analysis
    • Evaluation of the development projects 
    • Licensing-in and -out  including audits of the dossier
  • Validation of clinical development program via Scientific Advice at relevant Regulatory Agency