Clinical Program Strategy
Comprehensive clinical strategy expertise
Our integrated team partners with clients in all stages of clinical development, from early-stage to late-stage development, to identify opportunities and mitigate risks to their development programs. We leverage our deep experience across therapeutic areas and types of products (drugs, devices, biologics) to help you get into the clinic quickly and stay there with a well-developed and rationally positioned product.
We have worked with numerous clients moving from early laboratory experiments into the clinic for the first time, and we know what it takes to get into the clinic and to stay on track through each rationally designed and well justified clinical study on the way to marketing application submission. We bring this experience to bear wherever you are in development.
Clinical strategy development services
- Early development strategy
- Planning, oversight, and analysis of the data for Phase 1 and clinical pharmacology studies, including 1) SAD, MAD, bioavailability, bioequivalence and PK/PD studies; 2) Drug metabolism studies (in vitro and in vivo, animal and human); 3) Food-effect, drug-drug interaction, and other special-population (renal, hepatic, elderly, pediatric) PK studies; and 4) Clinical PK data review, analysis, and risk assessment to prioritize and guide design of follow-on studies. For example, Rho scientists analyze in vitro metabolism and SAD/MAD PK data to determine the need for, and design features of, clinical DDI studies including selection of interaction drug(s), dosing duration and frequency, and duration of washout between dosing periods.
- Planning, oversight, and analysis of Phase 2 through Phase IV clinical studies
- Planning, oversight, and conducting/analysis of efficacy and other more-complex clinical studies, including 1) Natural-history and historical-control studies; 2) Proof-of-concept and endpoint assessment studies; and 3) Critical late-stage ‘pivotal studies’ including adaptive and other complex study designs