Health & Technology Law Firm

Providing Excellence in Legal Services to Established Businesses, Emerging Companies and Individual Entrepreneurs

Clinical Trials and Human Subject Protections Services
 
 

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

 

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