Idea Exchange
Clinical Research Stage Contracting & Risk Management
Moving products toward market
When you need help with
- managing the complex legal contracting process for clinical studies
- negotiating agreements with various parties including clinical research sites, laboratories, sponsors, contract research organizations, and third-party vendors
- understanding the legal and regulatory framework of global clinical trials
- establishing clinical trial programs and negotiating aspects of contracting − including FDA and OHRP compliance counseling and management of IRB relations
our experienced team can assist
Parties engaging in clinical research are subject to a complicated set of regulatory, compliance, and practical considerations. We help pharmaceutical and life science companies, institutions, CROs, and SMOs navigate the myriad complexities involved in clinical trials to ultimately bring new and innovative products to the market.
Our nationally recognized healthcare team manages the legal contracting process for clinical studies, with clients ranging from startups to leading brands. Clinical trials involve a variety of lengthy and complex documents from master services and clinical trial agreements to informed consent forms and confidentiality agreements. We negotiate arrangements among biopharmaceutical companies, clinical research sites, principal investigators, central laboratories, contract research organizations, site management organizations, and third-party vendors, all of which are essential to a successful clinical trial.
We bring a pragmatic approach to keeping trials on schedule while ensuring our clients are properly protected from future liabilities. Our team provides risk management and compliance advice in the areas of insurance, indemnification, protection of confidential information, privacy, and intellectual property. We partner with in-house departments to implement processes that ensure drug development milestones and timelines remain on track.
Offering practical guidance to navigate an evolving global regulatory framework, we track new rules as they are issued to help clients to comply with national and global requirements while meeting their business objectives.
Our multidisciplinary team’s thorough understanding of U.S. and global clinical trials allows us to navigate clients through HIPAA, GDPR, and data privacy compliance issues around the world. We have successfully helped clients contract with clinical sites across Asia, Europe, and South America.
FEATURED ATTORNEY
Mike is a member of the firm’s Healthcare Team and leads its Clinical Trial Practice. He has more than two decades of experience providing pragmatic counsel and resolute advocacy to clients negotiating important agreements, managing risk, and making significant business decisions. Mike’s practice involves drafting and negotiating clinical trial agreements, master service agreements, letters of indemnification, nondisclosure agreements, informed consent forms, and other documents involved in clinical research. Mike’s 20+ years of litigation experience allows him the benefit of understanding how language is interpreted and applied when disputes arise. He advises clients involved in U.S.-based and global clinical trials on insurance, indemnity, intellectual property, and privacy, among other issues.
Experience
Following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.
Experience
- Negotiated arrangements among biopharmaceutical companies, clinical research sites, clinical research organizations, site management organizations, central laboratories, and third-party vendors
- Developed and reviewed master service agreements, clinical trial agreements, investigator-initiated trial agreements, informed consent forms, letters of indemnification, nondisclosure agreements, network participation agreements, site management agreements, and other vendor agreements
- Worked with pharmaceutical and life science companies with compounds, molecules, and biologics products in various stages of preclinical and clinical research
- Partnered with in-house legal departments and clinical operations to accelerate clinical site engagement and study subject enrollment to ensure drug development milestones and timelines remain on track
- Developed template agreements and “playbooks” for our clients to employ in negotiating clinical trial agreements
- Assumed the entire legal function of pharmaceutical company for various research studies and served as the primary contact between the CROs and clinical research sites in site enrollment process
- Navigated global privacy laws, including GDPR, to ensure clinical research data could be transferred to the U.S. for use in marketing applications
- Assisted with negotiation and revision to indemnification obligations of company with third-party vendor located in Ukraine based on the impact of the ongoing conflict
Parties engaging in clinical research are subject to a complicated set of regulatory, compliance, and practical considerations. We help pharmaceutical and life science companies, institutions, CROs, and SMOs navigate the myriad complexities involved in clinical trials to ultimately bring new and innovative products to the market.
Our nationally recognized healthcare team manages the legal contracting process for clinical studies, with clients ranging from startups to leading brands. Clinical trials involve a variety of lengthy and complex documents from master services and clinical trial agreements to informed consent forms and confidentiality agreements. We negotiate arrangements among biopharmaceutical companies, clinical research sites, principal investigators, central laboratories, contract research organizations, site management organizations, and third-party vendors, all of which are essential to a successful clinical trial.
We bring a pragmatic approach to keeping trials on schedule while ensuring our clients are properly protected from future liabilities. Our team provides risk management and compliance advice in the areas of insurance, indemnification, protection of confidential information, privacy, and intellectual property. We partner with in-house departments to implement processes that ensure drug development milestones and timelines remain on track.
Offering practical guidance to navigate an evolving global regulatory framework, we track new rules as they are issued to help clients to comply with national and global requirements while meeting their business objectives.
Our multidisciplinary team’s thorough understanding of U.S. and global clinical trials allows us to navigate clients through HIPAA, GDPR, and data privacy compliance issues around the world. We have successfully helped clients contract with clinical sites across Asia, Europe, and South America.
Following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.
Experience
- Negotiated arrangements among biopharmaceutical companies, clinical research sites, clinical research organizations, site management organizations, central laboratories, and third-party vendors
- Developed and reviewed master service agreements, clinical trial agreements, investigator-initiated trial agreements, informed consent forms, letters of indemnification, nondisclosure agreements, network participation agreements, site management agreements, and other vendor agreements
- Worked with pharmaceutical and life science companies with compounds, molecules, and biologics products in various stages of preclinical and clinical research
- Partnered with in-house legal departments and clinical operations to accelerate clinical site engagement and study subject enrollment to ensure drug development milestones and timelines remain on track
- Developed template agreements and “playbooks” for our clients to employ in negotiating clinical trial agreements
- Assumed the entire legal function of pharmaceutical company for various research studies and served as the primary contact between the CROs and clinical research sites in site enrollment process
- Navigated global privacy laws, including GDPR, to ensure clinical research data could be transferred to the U.S. for use in marketing applications
- Assisted with negotiation and revision to indemnification obligations of company with third-party vendor located in Ukraine based on the impact of the ongoing conflict
- Nationally recognized healthcare group; multidisciplinary team combines corporate, regulatory, and litigation experience
- Positioned at the forefront of clinical research
- Thorough understanding of U.S. and global clinical trials
- Seasoned healthcare and biosciences lawyers
- Trusted advisors to startups, leading pharmaceutical companies, and major U.S. academic institutions
