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Services
Every discipline. One accountable team.
Full-service or functional — K3 delivers the biometrics, operations, and safety work of clinical development with senior teams and quality by design. Every service below stands on classic delivery; where our technology can accelerate it, that's an option you choose.
Synergetic Scaling™
Change the level of support without changing the contract
Within a functional engagement, K3 operates at three levels of involvement — from guidance at the edges to fully integrated delivery. Programs move between levels as needs change, with no renegotiation and no change of team.
Lite Touch®
You retain control
Targeted expertise in specific functional areas, integrated with your existing processes.
Technical Oversight
Expert leadership at task level
Experienced professionals leading critical tasks, with quality assurance and knowledge transfer.
Full Outsource
End-to-end delivery
A dedicated cross-functional team running the process from start to finish.
Quality oversight and access to specialist expertise scale with the level — you pay for the involvement you need at the time, not for standing capacity you don't.
Disciplines
Our disciplines, in three families.
Each with its own senior practice — explore any in depth.
Biometrics
Biometrics
Biostatistics & Statistical Programming
Submission-grade biometrics, on the timeline you were promised.
Explore service →Biometrics
Clinical Data Management
Clean data. Locked on schedule. No surprises.
Explore service →Biometrics
Data Visualization & Dashboards
Your study, visible today — not last quarter.
Explore service →Biometrics
Preclinical Data Science & Bioinformatics
From assay data to development decision.
Explore service →Clinical Operations
Clinical Operations
Risk-Based Monitoring
Find site risk before it reaches your data.
Explore service →Clinical Operations
Site Monitoring & Management
Sites managed for compliance and data integrity.
Explore service →Clinical Operations
Clinical Resourcing & FSP
Senior specialists who arrive ready — and stay.
Explore service →Safety & Evidence
Safety & Evidence
Pharmacovigilance
Safety operations, run to the standard your label demands.
Explore service →Safety & Evidence
Medical & Technical Writing
Documents that read like the submission depends on them.
Explore service →Safety & Evidence
Real-World Evidence & HEOR
Evidence that supports value long after approval.
Explore service →The study lifecycle, covered end to end
Phase 01
Design
- Biostatistics
- Medical writing
- Preclinical data science
Phase 02
Start-up
- Site qualification
- EDC build
- Resourcing & FSP
Phase 03
Conduct
- Site monitoring
- Risk-based monitoring
- Data management
Phase 04
Lock & Analysis
- Database lock
- Statistical programming
- Dashboards
Phase 05
Submission
- Submission packages
- CSRs & narratives
- Pharmacovigilance
Phase 06
Post-approval
- RWE & HEOR
- Aggregate safety reports
- Registries
Enter at any phase — most sponsors start mid-lifecycle and expand from there.
Engagement models
Three ways to contract the same senior teams
The work does not change between these — the commercial shape and the governance around it do. Most sponsors run more than one at a time.
| FSP | Project-based | Resourcing | |
|---|---|---|---|
| Best when | Ongoing demand across a portfolio | A defined deliverable or study | A specific capability gap on your team |
| Scope | A standing function with agreed service levels | Fixed scope, named deliverables | Named individuals, your direction |
| Accountability | K3 owns the function and its governance | One accountable K3 lead | You direct; K3 maintains compliance |
| Scales by | Adding capacity without re-contracting | Adding the next project | Adding people |
| Governance | Recurring governance cycle with metrics | Milestone reviews to delivery | Your existing team cadence |
Compliance and training records are maintained by K3 in every model — including resourcing, where the people work under your direction.
Not sure which model fits?
Describe the work and we'll propose the shape — FSP, project, or placement — with named people and a timeline. A scoped response from a real person.
Contact K3