As a sponsor of clinical trials, your risk stems from three sources: trial subjects, government regulations, and your relationship with the research institution and investigators.
Register today for this fast-paced, information-packed, 90-minute webinar and learn how to protect your company. Expert Katherine Leibowitz will discuss indemnification, subject injury, informed consent, HIPAA authorizations, data access, trial budgets, publications, confidentiality, intellectual property and more. She will also delve into FDA financial disclosure regulation obligations.
This important presentation will emphasize negotiating a balanced agreement that leaves all parties reasonably satisfied and protected. Through realistic and practical guidance, you will master the skills to help you create terms sites will accept, that will also protect your interests. A Q & A session will follow the presentation to ensure a deeper knowledge of your concerns about Clinical Trial Agreements.
Learning Points and Questions to be Answered:
- Determining the risks of contracting with the wrong parties
- Which parties should sign the clinical trial agreement?
- What are the implications of the investigator leaving his/her practice?
- Financial ties sponsors should consider when selecting investigators and what types of financial arrangements may raise concerns at FDA
- Discussion of budgets exhibits
- What types of fees do trial sites typically expect the sponsor to pay?
- What is reasonable and what increases the parties’ risk for federal antikickback violations?
- How sponsors can avoid giving up valuable IP rights and confidentiality protection while granting the trial site the publication rights it needs
- The dangers of ignoring data access rights
- How do you ensure that you get the access you need?
- Developing strategies for negotiating risk-sharing and indemnification
Target Audience:
- Clinical/regulatory affairs
- Clinical project specialists
- Compliance officers
- Executive management
- General/corporate counsel
- Documentation managers and specialists
- Risk management specialists
- Consultants/service providers
Your Expert:
Katherine Leibowitz represents companies of all sizes that are developing and commercializing life sciences technology and electronic and information technology. She regularly counsels domestic and international companies on how to license, acquire, commercialize, and protect property subject to patent, copyright, trademark, trade secret, and privacy rights.
Katherine's practice in the life sciences field involves helping companies that are seeking to develop, test, and protect their technology both in the United States and internationally. She structures and negotiates agreements for multicenter clinical trials, contract research organization (CRO) services, core lab services, physician consulting, data safety monitoring board (DSMB) and clinical events committee (CEC) consulting, animal studies, supply, device sales and rental, and other documents for companies seeking regulatory approval for investigational devices. She regularly counsels companies on matters of general contract law, intellectual property ownership, and data access. Katherine provides companies with a cross-disciplinary approach to transactions by addressing general contract law, intellectual property, U.S. Food and Drug Administration (FDA) regulatory compliance, risk management, Health Insurance Portability and Accountability (HIPAA), fraud and abuse, and foreign legal and regulatory compliance, often working with members of the Hogan Lovells FDA regulatory practice, fraud and abuse group, HIPAA team, and the firm's foreign offices.
Katherine has extensive experience counseling startups and multinational corporations on domestic and international transactions relating to information technology and e-commerce, including drafting, review, and negotiation of agreements for content licensing; website development and hosting; co-branding; advertising; software development, licensing, and distribution; value-added reseller; referral and marketing; outsourcing; consulting; publishing; and strategic alliances. She has conducted numerous website audits. Katherine has drafted numerous website legal notices/disclaimers, privacy policies, and clickwrap agreements, and counseled companies on electronic contracting and European Union privacy matters. Additional past experience includes counseling purchasers and sellers regarding intellectual property transfers and audits in conjunction with mergers and other corporate reorganizations.
