The firm has experience representing biotechnology, medical device and pharmaceutical companies with regard to the entire spectrum of clinical trials counseling and contracting, including clinical trial site agreements, clinical trials management services and informed consent issues. The firm has provided in-house client training on clinical trials enforcement trends, and the legality of clinical trials study subject recruitment and retention methods. In addition, the firm has experience advising companies with regard to human subject protections. Whether you need help with a single clinical trials management agreement, or the review or development of a complete set of domestic and international clinical trial study site agreements, the firm can help you with the legal issues surrounding your trial.

HTLF provides biotechnology, medical device and pharmaceutical companies, universities, academic medical centers and hospitals with the following legal services:

  • Clinical trial site agreements for both single site and multi-center studies

  • Clinical trial management services agreements

  • Master services agreements

  • Laboratory and radiology services agreements

  • Investigator sponsored studies agreements

  • Data analysis and testing services agreements

  • Physician expert consulting agreements

  • Informed consent agreements

  • Counseling regarding domestic and foreign human subject protections requirements

  • Counseling and developing internal policies regarding the acquisition, use and storage of human biological samples

  • Counseling regarding study subject informed consent and drafting related informed consent agreements

  • Counseling regarding sponsor obligations and investigator relationships

  • Counseling regarding, and conducting internal client training programs, for clinical trials enforcement trends

  • Counseling regarding, and conducting internal client training programs for clinical trial naming

  • Reviewing clinical trial recruitment and retention materials for compliance concerns

  • Conducting internal client training programs for clinical trial subject recruitment and retention

What We've Achieved

  • Drafted multiple clinical trial study site agreements for both single site and multi-center studies for a global biotechnology company.

  • Advised and conducted stakeholder training for a global biotechnology company on data rights, patient consent, and Principal Investigator and Sponsor obligations for clinical.

  • Multi-year representation of an oncology drug company, including drafted and negotiating a variety of pre-trial initiation services, including agreements for Contract Research Organization services, Contract Manufacturing, Quality Control, and Patient Informed Consent.

  • Drafted suite of clinical trial study site agreements for trials pertaining to specialized medical devices for a national medical device company.

  • Consolidated and streamlined clinical study contracting activities world-wide for a biotechnology company, including  developing comprehensive contract negotiation guidelines, tools and model agreements; conducting related roll-out to, and training for, internal stakeholders and external contract research organizations. Achieving a 50% reduction of legal spend for clinical study contracting.