Understanding a regulatory agency’s expectations with regard to the safety and efficacy data necessary to support a later phase clinical study or marketing approval is essential to designing an effective clinical study. We work closely with medical professionals, key opinion leaders, and CROs to design clinical programs that maximize regulatory success.
The protocol and its supporting documents, such as the investigator brochure, informed consent, and case report form, are essential for initiation of a clinical study. Smart clinical study protocol development requires integration of scientific questions with business goals and an understanding of the regulatory arena. It is the clinical data, the clinical study report, and the integrated summaries of safety and efficacy that provide regulatory agencies with the information upon which to approve a product for marketing. We prepare targeted clinical trial materials and efficiently manage input from key opinion leaders, statisticians, and/or CROs to provide sponsors with cogent protocols and informed consent documents. We provide strategic medical writing at all stages of clinical development.
Under PREA, all applications for new active ingredients, new indications, new dosage forms, new dosage regiments, or new routes of administration are required to contain an assessment of the safety and efficacy of a drug product in pediatric patients unless this requirement is waived, deferred, or inapplicable. We work with sponsors to develop plans that balance FDA’s need for information on the safety of the drug in children with efforts to develop pediatric drug formulations and safely test the drug in patient populations.