KairosCRO Services LLC · Austin, TexasLeadershipInstitutional partnershipsContactTeam Vault
CLINICAL RESEARCH. CONNECTED.
Pharmacovigilance & Drug Safety/Strategy & governance

SAFETY SERVICES / 01

PV Strategy & Governance

Build a safety operating model with clear decisions, responsibilities and oversight.

Discuss this service
Illustrative research and medical expertise
Specialist expertise. Clear accountability.
What this service covers
  • Operating models
  • PV organizational design
  • Safety governance frameworks
  • Safety management plans
  • PV policies and SOPs
  • Vendor strategy and oversight
Potential deliverables
  • A documented operating model
  • Governance and responsibility matrix
  • Safety management plan and SOP roadmap
What to bring to the discussion
  • Product stage, portfolio and target markets
  • Existing processes and organizational responsibilities
  • Vendor arrangements and governance priorities

Qualified specialists, delivery arrangements and responsibilities are agreed before contracting.

WHAT WE CAN SUPPORT

Expertise for your scope.

  • Operating models
  • PV organizational design
  • Safety governance frameworks
  • Safety management plans
  • PV policies and SOPs
  • Vendor strategy and oversight

Potential deliverables

  • A documented operating model
  • Governance and responsibility matrix
  • Safety management plan and SOP roadmap

Start with your context

  • Product stage, portfolio and target markets
  • Existing processes and organizational responsibilities
  • Vendor arrangements and governance priorities