Study Design and Protocol Development

SCiAN’s consultants are experienced professionals with the knowledge to develop optimal trial designs and write 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.