Clinical Program & Trial Designs

"From Concept to Regulatory Submission"

SCiAN's consultants are seasoned professionals with the experience to create optimal trial designs and develop protocols for clinical development programs. From phase I/II PK and PD studies, early-phase dose-finding safety and efficacy studies to large global phase II/III trials, we can address your data management and biostatistics needs and recommend the best solution for your study. In total, we have collaborated with our clients in the design of more than 200 clinical trials.

Our senior consultants are invited by our biotech clients to participate in the oversight of clinical development programs as members of clinical / scientific advisory boards, clinical trial Steering Committees and DSMBs. We have supported our clients at FDA, EMEA and Health Canada meetings in IND and protocol discussions and in the presentation of the results of previous studies.

Our consultative services include:

Study Planning - Protocol Development

  • Clinical Advisory Groups: drug development, scientific, statistical & trial design consulting
  • Literature review, re-analysis / meta-analysis of reference studies
  • Review and analysis of preclinical studies (toxicity, pk)
  • Analysis in supports of the safety and efficacy sections of IBs
  • Simulation studies
  • Study design, sample size/power calculation, statistical considerations, randomization, including adaptive methods
  • Client representation or support at IND / pre-study regulatory meetings.

Clinical Trial Design - Indication-Specific

  • Phase I (in healthy volunteers) and phase I/II safety trials (in patients)
  • Pharmacokinetic and pharmacodynamic studies
  • Phase II exploratory efficacy (PoC) and dose-finding trials
  • Late phase IIb and seamless adaptive II/III designs
  • Adaptive phase II designs and II/TT seamless trials
  • Randomized controlled phase III trials; designs for orphan indications
  • Bio-equivalence and therapeutic equivalence trials.

NDA Support

  • Client representation at pre-NDA regulatory meetings on statistical & trial design issues
  • Integrated safety analysis ISS
  • Integrated efficacy analysis ISE.