PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals for both brand name and generic drug products. Our experienced and professional staff of scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include, among others first in human, novel drug therapies, first-in-class, efficacy, safety, non-inferiority, pharmacokinetic and pivotal trials.
Designing Clinical trials involves a myriad of variables across a variety of disciplines and functional areas. PDG helps our clients address these variables with ease in a way that saves time and controls costs. Our CRO consulting and study placement is a critical early step. We select, validate, qualify and provide oversight such that study sites keep progress on time or ahead of schedule. When PDG writes or edits a protocol, all clinical and regulatory elements that shape the requirements for execution of the trial are addressed. Our designs include adaptive trials and our approaches are always confirmed with FDA. Our statisticians develop ad-hoc analyses and simulations and to investigate underlying assumptions or study results. Our efforts integrate IND support, IRB compliance, pending NDA submissions and anticipated regulator inquiries. We also provide critical review of Clinical Study Reports and publications describing the completed studies.