Our projects include Phase I through Phase IV clinical trials.
Phase I Experience
Single ascending dose (SAD), multiple ascending dose (MAD), pharmacokinetic, bioequivalence, and multi-stage cross-over trials.
Phase II Experience
Providing a strategic balance between cost and sample size by helping our clients reduce error in order to increase the power of the study within a manageable budget. In many cases we can increase the impact of the sample size by 20-30%.
Phase III Experience
Large-scale Phase III trials confirm efficacy and monitor adverse reactions in a broader patient population. These pivotal studies compare the new drug to a placebo or existing treatment. Statistical rigor is crucial, as this data forms the basis for FDA approval. Our expertise helps design robust protocols, optimize recruitment, and ensure statistical power for clear results.
Phase IV Experience
After approval, Phase IV involves ongoing post-marketing surveillance. This detects rare or long-term adverse effects and gathers more information on optimal use. It can include long-term safety studies or specific patient populations. We assist with pharmacovigilance plans and real-world data analysis, continually monitoring safety and maximizing therapeutic potential.
Client Roster
Pentara serves a range of clients from pharmaceutical and biotech companies to academic groups.