Research has become a critical component of the strategic vision and goals of the health care industry. Robinson+Cole's lawyers work collaboratively with sponsors, clinical research organizations, sites, and investigators to ensure that our clients are protected without harm to either the speed to trial commencement or the overall relationship. We can assist with navigating ethical and regulatory complexities associated with research activities as well as with the heightened concerns raised by certain subject groups, such as children.
Our lawyers advise on all aspects of the clinical trial setting—from nondisclosure agreements to material transfer agreements to clinical trial agreements and related informed consent and HIPAA authorization forms. We have strong experience implementing multiparty collaborative research agreements as well as the intellectual property management arrangements and policies that go hand in hand with a strong research program.
We advise on establishing and operating institutional review boards, government regulation, and funding of clinical research, and on laws and guidance relating to sponsor interactions with providers.
Many of our clients also turn to us for assistance with the exploitation of results stemming from their research efforts. We implement commercialization arrangements including licenses and invention administration agreements. We also assist with implementation of consulting arrangements in which a consultant is engaged to assist with aspects of the research or exploitation of developments.