Investigator-Driven Clinical Trials

"From Concept to Manuscript"

SCiAN's senior consultants can help your team to create optimal trial designs and develop protocols for INVESTIGATOR-DRIVEN clinical trials:

  • Single center / local phase IV trials sponsored by pharma;
  • Development phase I/II - II studies sponsored by pharma or biotech;
  • Clinical / medical investigations sponsored by academic and other not-for-profit groups. 

SCiAN can address your protocol development, study design, data management, biostatistics and manuscript writing needs. In total, we have worked on more than 50 clinical trials / investigations in close collaboration with investigators / key opinion leaders in a number of indications.

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.