Life Sciences Contract Services

Saphan Pont's Life Sciences Contracts practice supports sponsors, CROs, hospitals, health systems, academic medical centers, and research institutions across the full lifecycle—Commercial, R&D, Clinical Trials, Manufacturing, and HCP engagements. We pair proven playbooks with skilled drafting and negotiation, collaborating with your teams to align business goals with FDA/EMEA, ICH-GCP, HIPAA, and GDPR. Leveraging international experience, we guide clients through the legal intricacies of ethical, groundbreaking studies, delivering faster study start-up and durable contracts that protect patients, data, and your science.

Bringing new drugs and devices to patients starts with clinical research and trials. Partnering with clients, Saphan Pont Law drafts and negotiates the complex agreements that power development and protect your programs.

Areas of Focus

Clinical Trials

  • Health Care Providers (HCPs) and Key Opinion Leader (KOLs) engagement
  • Billing Research-Related Clinical Services
  • Creating and negotiating individualized CTAs
  • Tailoring CRO-provided templates
  • Reviewing informed consent forms
  • Negotiating CRO service agreements
  • Negotiating clinical trial supply and distribution agreements
  • Protection of Data Privacy and Security
  • Enabling Secondary Use of Data and Specimens

Government Grants and Contracts

  • Federal grant agreements (e.g., NIH/NSF/CDC/DoD)
  • Federal cooperative agreements (e.g., NIH/DoD mechanisms with substantial agency involvement)
  • SBIR/STTR Phase I–III awards (grants and contracts)
  • VA Office of Research and Development awards (Merit Review, CSP, Career Development)
  • Cooperative Research and Development Agreements (CRADAs) with federal labs
  • Subawards and subcontracts under federal grants and contracts (with flow-downs and monitoring)
  • Grants management addenda and compliance documents (Bayh-Dole IP, data rights, public access/data sharing)

Academic Collaborations

  • Investigator initiated trials
  • Sponsored research
  • Academic consulting
  • Materials transfer arrangements
  • Research collaborations
  • Clinical development collaborations
  • Consortiums
  • IRB, IACUC (animal research) and IBC (biosafety)

Drug Development Agreements

  • Master Service Agreements
  • Manufacturing Agreements
  • Supply Chain Agreements
  • Quality Agreements