For hospitals & clinics

Build a research program your staff can run and sponsors will trust.

We set up the research department from the ground up: the procedures, the human research protection program, the regulatory footing, the process for evaluating and accepting studies, and the first sponsored studies through activation. The program belongs to you. We do the building and the training.

Tell us about your site → What we build

Sponsors want sites that are ready. Most hospitals are not there yet.

Interest is rarely the problem. Investigators want to offer trials to their patients, and leadership wants the program. What is usually missing is the infrastructure that lets a site take on a study and run it properly. In practice that looks like this:

  • No SOP set, or one inherited from somewhere else and never followed
  • No HRPP, no IRB pathway, or a reliance arrangement nobody has set up
  • Feasibility questionnaires answered ad hoc, or not at all
  • Study opportunities that stall in legal, in compliance, or in the CMO's inbox
  • Training, delegation, and essential document control that would not survive a qualification visit
  • A research coordinator who is also doing three other jobs

Who this is for

  • Community hospitals with no research office yet
  • Specialty clinics and physician groups being asked to join trials
  • Health systems reviving a dormant or under-resourced program
  • Sites that need to pass a sponsor qualification visit or an inspection

What we build

Each of these is a finished deliverable, written and reviewed and ready to use. None of it is a recommendation for someone else to carry out.

Standard operating procedures

The SOP set a research office runs on, covering study start-up, informed consent, source documentation, investigational product, adverse event and deviation reporting, monitoring visits, quality assurance, and records retention. We write them to ICH E6(R3) and to FDA and OHRP requirements, and we adapt them to how your hospital actually operates.

HRPP and IRB setup and policy

The human research protection program itself. That means the policies and procedures, the IRB structure and operating procedures where a local board makes sense, reliance arrangements with a central or external IRB where it does not, and the documentation that shows the program works as written.

Regulatory readiness

Getting the site to a point where it can be inspected, monitored, or qualified by a sponsor without surprises. We handle registrations, training records, delegation and credentialing, and essential document control, and we make sure you know what a reviewer is going to ask for before they ask.

Study intake and feasibility

A repeatable process for deciding whether a study fits your site, weighing investigator interest, patient population, staffing, budget, timelines, and risk. The point is for the site to say yes to the right studies and no to the wrong ones, quickly and with a paper trail.

Securing and onboarding studies

Positioning the site with sponsors and CROs, responding to feasibility questionnaires, supporting qualification visits, and running start-up through activation. This is where the infrastructure turns into an active, revenue-generating research program.

Training and hand-off

Role-based training for coordinators, investigators, and leadership on the procedures we have written, and a hand-off designed so that your team runs the program without us.

How an engagement runs

Scope depends on where your site is starting from, but the general shape is the same.

  1. Assess

    We review what exists, including policies, past research activity, staffing, IRB arrangements, and institutional constraints. We interview the stakeholders. Then we deliver a written gap assessment with a prioritized plan.

  2. Build

    We write the SOPs, stand up the HRPP and IRB framework, and put the intake and feasibility process in place, working with your leadership, compliance, and clinical staff throughout.

  3. Activate

    We help the site secure its first studies and take them through start-up, so the new infrastructure gets used on real work instead of sitting in a binder.

  4. Sustain

    We hand off to your team with the documentation and training they need to run the program, and we stay available as it grows.

What you walk away with

The exact list depends on scope. Everything on it is yours to keep and change.

  • Complete SOP manual, indexed and version-controlled
  • HRPP policy set
  • IRB charter, forms, and operating procedures, or executed reliance agreements
  • Regulatory binder and essential document templates
  • Training curriculum and completed training records
  • Delegation of authority and credentialing templates
  • Study intake workflow and feasibility scorecard
  • Sponsor-facing site capabilities profile
  • Budget and coverage analysis templates
  • Written gap assessment and prioritized plan

Common questions

Do we need our own IRB?
Not necessarily. Many sites are better served by relying on a central or external IRB than by standing up their own board. The right answer depends on your study mix, your volume, and your institution's requirements. We settle it during the assessment and build whichever pathway fits.
Can our existing compliance office run the program afterward?
Yes, and that is how we design it. Everything we write is meant to be run by your staff, and the hand-off includes the training and documentation to do that. We stay available afterward, but the program does not depend on us.
What does "research-ready" mean to a sponsor?
It means a qualification visit finds what it expects to find: written procedures that are actually followed, a working IRB pathway, trained and delegated staff, controlled essential documents, and a site that can answer feasibility questions accurately and quickly. That is the bar we build to.
Can you take on just one piece, like SOPs only or IRB setup only?
Yes. Some sites want the full build and some want one component. Either way the assessment comes first, so whatever we build fits the rest of the program.
What do you need from us to start?
A conversation to start, then access to whatever already exists: current policies, past study records if there are any, org charts, and some time with the people who will own the program. We take it from there.

Find out how far your site is from research-active.

Tell us where the site is today and what you want it to become. We will tell you what it would take.

Tell us about your site →