Clinical Research
Clinical Research
Bench research, animal research, and clinical trials have unique business, regulatory, operational, and ethical considerations that often require highly specialized advice. Our attorneys have been general counsels of major universities and research hospitals, senior lawyers in the federal government, IRB members, and an advisor to a foreign government on national research policy. Through these in-house experiences, our attorneys have had administrative responsibility for clinical trial regulatory affairs, technology transfer offices, and an IRB office. We advise hospitals, universities, life sciences companies, and foundations with the following:
- Regulatory aspects of clinical trials, including the Common Rule, Food and Drug Administration regulations, and clinical trial registration.
- Regulatory aspects of research with animals.
- Funding for research, including federal and private grants and Medicare billing.
- Human research protection program design and implementation.
- IRB operational improvement and reliance agreements, including to facilitate single IRB mandates.
- The creation and sharing of data and tissue repositories.
- Institutional compliance auditing.
- Investigations of alleged research misconduct or noncompliance with federal grant requirements.
- Conflict of interest policy development and implementation.
- All types of clinical trial, investigator-initiated research, and research collaboration agreements.
- Acquisitions, consolidations, or other corporate restructurings that involve the transfer of, or otherwise impact, clinical research operations
In addition, we have deep experience with the globalization of biomedical research. In addition to structuring research collaborations in "traditional" jurisdictions like the UK, EU, Canada, and China, we have on-the-ground experience establishing clinical trials and data and specimen collection projects throughout Africa, Asia, and the Middle East, as well as experience establishing research and medical partnerships on six continents.
Bench research, animal research, and clinical trials have unique business, regulatory, operational, and ethical considerations that often require highly specialized advice. Our attorneys have been general counsels of major universities and research hospitals, senior lawyers in the federal government, IRB members, and an advisor to a foreign government on national research policy. Through these in-house experiences, our attorneys have had administrative responsibility for clinical trial regulatory affairs, technology transfer offices, and an IRB office. We advise hospitals, universities, life sciences companies, and foundations with the following:
- Regulatory aspects of clinical trials, including the Common Rule, Food and Drug Administration regulations, and clinical trial registration.
- Regulatory aspects of research with animals.
- Funding for research, including federal and private grants and Medicare billing.
- Human research protection program design and implementation.
- IRB operational improvement and reliance agreements, including to facilitate single IRB mandates.
- The creation and sharing of data and tissue repositories.
- Institutional compliance auditing.
- Investigations of alleged research misconduct or noncompliance with federal grant requirements.
- Conflict of interest policy development and implementation.
- All types of clinical trial, investigator-initiated research, and research collaboration agreements.
- Acquisitions, consolidations, or other corporate restructurings that involve the transfer of, or otherwise impact, clinical research operations
In addition, we have deep experience with the globalization of biomedical research. In addition to structuring research collaborations in "traditional" jurisdictions like the UK, EU, Canada, and China, we have on-the-ground experience establishing clinical trials and data and specimen collection projects throughout Africa, Asia, and the Middle East, as well as experience establishing research and medical partnerships on six continents.
Experience
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We advised hospitals, research institutions, life sciences companies, and Institutional Review Boards on the collection, use, and sharing of data...
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We represent PathAI, an AI-powered pathology company, across a variety of matters, including advising on mergers and acquisitions, healthcare and...
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We advise a public university system on compliance with the rules associated with grants and contracts from NIH, NSF, and...
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We represented Boston Children's Hospital with intellectual property, business, and government contracting issues associated with VaccineFinder. We also assisted Boston...
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Our team assisted a prominent children’s hospital with a range of industry-sponsored and investigator-initiated research agreements.
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We counseled a major research university with all regulatory and contracting aspects of a multi-national investigator-initiated clinical trial.
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We counseled an academic medical center on international data protection regulations that apply to a global disease surveillance platform involving...
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We advised research institutions and laboratory companies on Medicare billing for clinical trials, observational studies and other research.
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We advised a national clinical trials network on identifying and managing conflicts of interest of senior leaders with multiple faculty,...
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We advised a pharmaceutical company on federal grant funding and clinical trials for oncology and antiviral compounds.
Experience
-
We advised hospitals, research institutions, life sciences companies, and Institutional Review Boards on the collection, use, and sharing of data...
-
We represent PathAI, an AI-powered pathology company, across a variety of matters, including advising on mergers and acquisitions, healthcare and...
-
We advise a public university system on compliance with the rules associated with grants and contracts from NIH, NSF, and...
-
We represented Boston Children's Hospital with intellectual property, business, and government contracting issues associated with VaccineFinder. We also assisted Boston...
-
Our team assisted a prominent children’s hospital with a range of industry-sponsored and investigator-initiated research agreements.
-
We counseled a major research university with all regulatory and contracting aspects of a multi-national investigator-initiated clinical trial.
-
We counseled an academic medical center on international data protection regulations that apply to a global disease surveillance platform involving...
-
We advised research institutions and laboratory companies on Medicare billing for clinical trials, observational studies and other research.
-
We advised a national clinical trials network on identifying and managing conflicts of interest of senior leaders with multiple faculty,...
-
We advised a pharmaceutical company on federal grant funding and clinical trials for oncology and antiviral compounds.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Professionals
Name | Phone | |
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Audrey J. Anderson Counsel |
(615) 742-6296 | audrey.anderson@bassberry.com |
Tabitha L. Green Associate |
(615) 742-7751 | tabitha.green@bassberry.com |
Clint D. Hermes Counsel |
(865) 521-2025 | clint.hermes@bassberry.com |
Whitney Mosey Associate |
(901) 543-5953 | whitney.mosey@bassberry.com |
Elaine C. Naughton Associate |
(615) 742-7920 | elaine.naughton@bassberry.com |
Todd R. Overman Member |
(202) 827-2975 | toverman@bassberry.com |
Dawn Perez-Slavinski Member |
(202) 827-7973 | dawn.perez-slavinski@bassberry.com |
Angelique M. Salib Associate |
(202) 827-7978 | angelique.salib@bassberry.com |
Danielle M. Sloane Member |
(615) 742-7763 | dsloane@bassberry.com |
Jacob B. Stansell Associate |
(615) 742-7898 | jacob.stansell@bassberry.com |
Nesrin Garan Tift Member |
(615) 742-7861 | ntift@bassberry.com |
Publications
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October 1, 2024 | Bloomberg Law
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July 16, 2024 | Firm Publication
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April 26, 2024 | Firm Publication
Past Events
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June 2-4, 2024 | Westlake Village, CaliforniaConsero Healthcare
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March 19, 2024 | WebinarStrafford Publications
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October 17, 2023 | WebinarStrafford
Media Mentions & Firm News
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October 9, 2024 | Law360 Healthcare Authority
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June 5, 2024 | Law360 Healthcare Authority
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April 24, 2024 | Law360
Publications
-
October 1, 2024 | Bloomberg Law
-
July 16, 2024 | Firm Publication
-
April 26, 2024 | Firm Publication
Past Events
-
June 2-4, 2024 | Westlake Village, CaliforniaConsero Healthcare
-
March 19, 2024 | WebinarStrafford Publications
-
October 17, 2023 | WebinarStrafford
Media Mentions & Firm News
-
October 9, 2024 | Law360 Healthcare Authority
-
June 5, 2024 | Law360 Healthcare Authority
-
April 24, 2024 | Law360
Contact
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.