One of the most important stages in advancing drug therapies to approval is the clinical trial process and no single solution will fit every situation. A concentrated and customized effort is needed for every phase of clinical trials. Not having the in-house capabilities to resource the Proof-of-Concept (POC) or Phase I/IIa studies, Modoc will see that your study is correctly resourced, that timelines are met, and that the quality of work you desire and deserve is delivered. We have the services, staff and expertise to carry out the most complex Phase I/IIa studies, including first-time-in human, dose-escalation, clinical pharmacology (e.g., food-effect, pharmacokinetic/pharmacodynamic, cardiotoxicity, ADME) from start to finish. Our dedicated study teams consult on the most efficient study strategy, study planning and execution of your studies, including medical writing and regulatory support.
Proof-of-Concept (POC) Clinical Trials
Proof of Concept (PoC) studies provide a faster, more economical approach to finding the signals of efficacy needed to determine the therapeutic potential and value of a new product. With the limited resources of most smaller groups/companies, taking the best approach to designing and implementing a PoC study plan enables key efficacy questions to be addressed quickly and confidently in order to achieve the “Go/No-Go” decision point.
Phase I/IIa Clinical Trials
The level of attention needed for the successful implementation of early phase studies is provided by a dedicated Modoc team. We become a virtual extension of your own team, ensuring consistency in work across your studies and alignment in our processes and yours to strive for trial success.