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

Vendor & CRO Agreements

  • Master Service Agreements (MSAs) and Work Orders for vendors including manufacturing, supply chain, KOLs, consultants, and CROs
  • Negotiating CRO service agreements
  • Negotiating clinical trial supply and distribution agreements
  • Quality Agreements
  • KOL and Consultant engagement and contracting

Investigator / Site Agreements

  • Creating and negotiating individualized Clinical Trial Agreements (CTAs)
  • Tailoring CRO-provided CTA templates (playbook-driven model)
  • Reviewing, drafting, and negotiating Informed Consent Forms — including HIPAA and legal language for compliance and sponsor/CRO protection
  • ICF & CTA alignment — ensuring the template contract is consistent with the ICF
  • Budget template construction and FMV-anchored negotiation parameters
  • Reviewing and advising on site payment terms and documentation for payments outside FMV parameters
  • Protection of Data Privacy and Security (HIPAA / GDPR)
  • 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

Study Closeout & Early Termination Support

Most contracts assume studies will close normally. When studies end early or sites are terminated, sponsors and CROs are often unprepared. Saphan Pont Law reviews your agreements upfront to surface closeout obligations, and provides advisory support when early termination requires managing contractual obligations by all parties — including final payment terms, data delivery, financial disclosure filing reminders, and site-specific wind-down requirements.