To make it to market, new drugs and medical devices must first undergo clinical research and trials. PETLIC negotiates the often complicated contracts that frame these trials. We advise clients on drafting informed consents that meet all regulatory requirements, as well as on interactions with institutional review boards concerning protocols and study monitoring.
For trials supported by the National Institutes of Health or other government agencies or grants, we carefully craft the proper trial documentation to ensure regulatory compliance, protect intellectual property interests and minimize business liability exposure.
