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.