Pharmaceutical
Portfolio-scale Biometrics and Clinical Operations for sponsors running Phase I–IV programs across multiple therapeutic areas.
Where to start
Eight sponsor types, one adaptable model
Pick the profile that matches your organization to see how the engagement is scoped — or talk to us if you sit across more than one.
Biotechnology
A lean internal team's de facto Biometrics and Clinical Operations department, without adding another vendor to manage.
Medical Device
Analysis plans and site coordination built around device-specific endpoints, IDE studies, and mid-study design iterations.
Emerging Startups
Full biostatistics, data management, and clinical operations capability for a first trial, without standing up the function in-house.
Academic Research
Biostatistics, data management, and clinical operations scoped to grant-funded budgets and IRB compliance requirements.
Government Research
CDISC-aligned programming and regulatory discipline for publicly funded, multi-stakeholder research programs.
Digital Health
Data structures and TrialKit EDC configuration built for wearables, apps, and remote data capture alongside site-entered data.
CROs
Subcontracted Biometrics and Clinical Operations depth for CROs that need niche expertise or overflow capacity, delivered inside your own SOPs.
What doesn't change
Whatever the sponsor, the same standard applies
The engagement model flexes to fit the sponsor. The team, the data quality, and the accountability don't.
One accountable team
Biometrics and Clinical Operations report through the same team regardless of sponsor type, so nothing drifts between handoffs.
Engagement that flexes
Full-service delivery or embedded FSP staffing, scoped to the program's size, phase, and funding structure.
The same standard everywhere
Documented SOPs, CDISC-aligned data, and Pinnacle 21 validation apply the same whether the sponsor is commercial, academic, or government-funded.
What sponsors say
Feedback from across industries
Common questions
Before you pick a profile
What sponsors ask most before scoping an engagement across industries.
Not sure which model fits your program?
Tell us your sponsor type, study phase, and where your internal team stands — we'll map it to an engagement model.