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.