Consulting - Clinical 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:
Trial Designs
- Phase I/II safety and dose finding studies
- Phase II exploratory efficacy trials
- Adaptive designs
- Randomized controlled phase III trials
- Phase IIIb - IV and pharmacovigilance trials
- Pharmacokinetic and pharmacodynamic studies
- Bio-equivalence and therapeutic equivalence trials.
Protocol Development
- Statistical planning (sample size estimation, randomization,
and power calculations)
- Complete protocol development
- Literature review and meta-analysis
- Client representation or support at regulatory meetings (INDs
and NDAs).
Relevant SCiANEWS
Publications
Bayesian Designs for
Clinical Trials in Early Drug Development (2007), St. Clare Chung
& Miklos Schulz