Research infrastructure for sites.
Study execution for sponsors.
We build research departments for hospitals and clinics that want to run studies. We design and run studies for sponsors, either as their research function or as an extension of the one they already have. It is the same team on both sides of the trial.
Research is expected. The infrastructure usually isn't there.
Hospitals are being asked to offer trials to their patients. Sponsors are being asked for clinical evidence, usually sooner than their teams can produce it. Both have to do it under regulatory scrutiny, on a deadline, with people who already have other jobs. The problems tend to look the same on either side.
- No written procedures that a sponsor or an auditor would accept
- No clear IRB pathway, or one that takes months
- Study opportunities that stall in legal, compliance, or feasibility
- Protocols that read well on paper and fall apart at a real site
- Data that was collected without much thought about the analysis it has to support
- Nobody whose full-time job is to make the study happen
Who we work with
We serve two kinds of clients. Pick the one that describes you.
We build your research department.
Standard operating procedures, HRPP and IRB setup and policy, regulatory readiness, study intake and feasibility, and help securing and onboarding sponsored studies. The result is a program your own staff can run and that sponsors will place studies with.
Research infrastructure for sites → SponsorsWe operate as your research function.
Protocol development, regulatory strategy and submissions, instrument and data capture design, and study operations through closeout. We work as an extension of your team and size the engagement to the program.
Study design and execution for sponsors →Why clients work with us
Both sides of the study
We build site infrastructure and we run sponsor studies, and each informs the other. The procedures we write for a hospital reflect what sponsors look for before they place a study there. The protocols we write for a sponsor reflect what a coordinator can realistically do in clinic.
Finished work, not recommendations
What you get at the end of an engagement is the infrastructure: the SOP set, the IRB policy manual, the feasibility process, the protocol, the case report forms, the submission package. These are documents a regulator, an IRB, or a sponsor can pick up and use as they are.
Continuity from start to close
The people you meet in the first conversation are the people who do the work, and they stay with the engagement through activation or closeout. You will not be handed off to a team you have never met.
How an engagement runs
The details depend on which track you are on, but the shape is the same.
Assess
We review what already exists, whether that is policies, past research activity, staffing, IRB arrangements, or the product and the question you need answered, and we put in writing what it will take to get where you want to be.
Build
We write the procedures, stand up the IRB pathway, develop the protocol and data systems, and train the people who will use them, working alongside your leadership, compliance, and clinical staff.
Run
For a site, we help secure and activate the first studies. For a sponsor, we operate the study day to day through closeout. Either way, we hand off with the documentation your team needs to keep going.
Built to the standards reviewers hold you to
Every procedure, policy, protocol, and submission we produce is written against the regulations and guidance that IRBs, sponsors, and inspectors actually apply.
- 45 CFR 46 (Common Rule)
- 21 CFR Parts 50, 56, 312, 812
- ICH E6(R3) Good Clinical Practice
- AAHRPP accreditation standards
- HIPAA Privacy Rule for research
- 21 CFR Part 11
Tell us about your project.
A short conversation is usually enough for us to tell you whether we are the right team and what a first scope would look like.