Standards for the research itself
Pharmaceutical R&D compliance starts before any patient is enrolled. Nonclinical safety studies meant to support an FDA application are generally expected to follow good laboratory practice standards, and the agency may question data from studies that did not. Before a clinical trial begins in the United States, the sponsor usually needs an investigational new drug application in effect, along with review by an institutional review board for each study. During the trial, good clinical practice standards govern how the sponsor monitors sites, how investigators obtain informed consent, and how adverse events are reported. Contract research organizations often perform much of this work, but the sponsor remains responsible for overseeing it.
Data integrity and transparency
Regulators expect research data to be trustworthy from the moment it is recorded, and gaps in audit trails or unexplained changes can undermine an entire study. Many clinical trials must be registered on ClinicalTrials.gov and have results reported there, and failing to do so can lead to notices and penalties. Applications to the FDA generally have to address the financial interests of clinical investigators in the sponsor. If federal grant funding supported any of the research, allegations of research misconduct follow separate federal procedures. Keep protocols, amendments, monitoring reports, and correspondence with investigators and the agency organized from the start.
Reviewing a development program
We begin with the stage of development, the studies planned or underway, and the vendors involved. Then we look at contracts with research organizations and clinical sites to see whether responsibilities for monitoring, safety reporting, and data ownership are assigned clearly. We also review informed consent forms and site payment arrangements, which can raise both regulatory and fraud and abuse questions. Where research crosses borders, we consider how foreign data and foreign sites will be treated in a U.S. application. You leave with a list of gaps tied to the program's next milestone.
