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A development partner, not just a vendor

Colttas was built by people who have lived clinical research from the inside — across CRO and sponsor environments — and who know what it takes to keep a trial moving.

Clinical care environment Built by people who have lived clinical research
Our story

Colttas Inc was founded on a simple conviction: clinical trials succeed or stall on the strength of their people and the discipline of their operations. We've seen first-hand how the right CRA, the right data manager, or the right functional team can be the difference between a program that drifts and one that delivers.

Our team brings deep roots across the clinical research landscape — sponsor-side rigor and CRO-side delivery — spanning monitoring, trial management, data management, safety, regulatory, and biostatistics. That dual perspective means we understand both sides of every engagement: the pressure on sponsors to advance a pipeline, and the operational reality of getting the work done to standard.

We started Colttas to give sponsors, biotechs, and CROs a single partner for both needs — the talent to staff a study and the functional capability to run it. Whether you bring us in for one specialist or to own an entire function, we hold ourselves to the same standard: do work you'd be proud to put in front of an inspector.

Our mission is to accelerate clinical development by giving research teams the expert talent and operational depth they need — and to be the partner clients trust with the work that matters most.

— The Colttas Inc team
By the numbers

Depth you can measure

48h
Average time to first qualified shortlist
Phase I–IV
Full development lifecycle coverage
100%
ICH-GCP aligned delivery
9+
Therapeutic areas supported
Our values

How we show up on every engagement

The principles that govern how we hire, how we place, and how we deliver.

Operational Excellence

We sweat the details that protect data integrity, timelines, and inspection readiness — because in clinical research, the details are the work.

Regulatory Knowledge

ICH-GCP and the evolving regulatory landscape aren't an afterthought — they're built into how we screen talent and deliver functional work.

Long-Term Partnership

We invest in relationships over transactions — with clients whose programs we support for years, and professionals whose careers we help build.

Our team

The expertise behind the partnership

A senior team with deep operational roots across sponsor and CRO environments — organized around the functions that move your trial forward.

Clinical Operations

Monitoring · Trial Management · Startup

Led by professionals with sponsor- and CRO-side operations experience across Phase I–IV programs and complex therapeutic areas.

Functional Services

Data Management · Biostatistics · Safety

Builds and scales end-to-end functional teams — from CRF design and edit checks through database lock, analysis, and submission.

Quality & Regulatory

GCP · QA · Regulatory Operations

Owns inspection-ready delivery, TMF oversight, and regulatory submission support aligned to FDA, EMA, and MHRA expectations.

Why teams choose Colttas

Trusted with the work that matters

Sponsors, biotechs, and CROs partner with us because we behave like part of their team — accountable for outcomes, fluent in their world.

We speak clinical development

No translation layer. We understand your protocol, your endpoints, and your constraints.

Talent and functions under one roof

Scale from a single hire to a fully outsourced function without changing partners.

Quality you can defend

We work to your SOPs and GCP standards, with documentation built for audit.

Flexibility that protects timelines

We flex capacity up or down as your program shifts, so delivery never stalls.

Work with us

Let's build the team your trial deserves

Talk to us about staffing your study, outsourcing a function, or both — and see what a real development partner feels like.