Regulatory & compliance infrastructure
SOP library, essential-document binders, IRB selection and submission, FWA and OHRP registration, Form FDA 1572, delegation of authority logs, and a documentation system that survives inspection.
Clinical research site development
Your clinic is already the hard part.
You have the patients, the clinicians and the trust of your community. What you don't have is the regulatory infrastructure, the trained coordinators and the sponsor relationships that turn a practice into a clinical research site. We build all three — and stay until your first study reads out.
Built to ICH-GCP E6(R3) and FDA regulation from day one — not retrofitted after your first audit.
We build to
ICH-GCP E6(R3)
FDA 21 CFR Parts 11, 50, 54, 56 & 312
IRB & OHRP registration
HIPAA & Medicare billing compliance
The gap we close
Sponsors don't reject clinics for lack of patients. They reject them for lack of proof.
A sponsor evaluating a new site is asking four questions before they ever look at your enrolment potential: can you document, can you comply, can you deliver on timelines, and can you survive an inspection?
Most practices answer "not yet" to all four — not because they lack capability, but because nobody has ever built the operational spine that research runs on. That spine is a discipline of its own: written procedures, delegation logs, temperature-controlled storage, source documentation that stands up to a monitor, a coordinator who has run a screening visit before. It takes months to assemble and is nearly impossible to learn during your first study.
We assemble it before your first study — so your first sponsor sees a site, not an experiment.
<5%
of eligible U.S. patients ever take part in a clinical trial — most are never offered one close to home.
Industry estimate, National Cancer Institute / NIH
80%
of trials fail to meet their original enrolment timeline, and sponsors keep paying for the delay.
Widely cited industry figure, Tufts CSDD
75%
of participants in FDA-approved drug trials in 2020 were white — a diversity gap sponsors are now required to close.
FDA Drug Trials Snapshots, 2020
What we do
End-to-end site development, under one engagement
Every piece a sponsor, CRO or FDA inspector will look for — designed together so nothing contradicts anything else.
Staff training & credentialing
GCP and human-subjects certification, protocol and source-documentation training, IATA shipping, and complete training files for every investigator and coordinator on your delegation log.
Sponsor & CRO business development
A site capabilities profile that gets read, registration on the databases sponsors actually search, feasibility questionnaire responses, and budget and contract negotiation that protects your margin.
Study startup & execution
Site initiation readiness, recruitment and retention planning, visit workflow design, drug accountability, monitoring-visit preparation and query resolution — with us in the room, not on a slide.
Diversity & community enrolment
Enrolment strategy for the populations sponsors are now required to reach, community and faith partnership design, language access, and support for sponsors' FDA Diversity Action Plan commitments.
Quality, audit & inspection readiness
Internal audits, mock FDA BIMO inspections, CAPA development, protocol deviation management, and the quality system that keeps a sponsor coming back with study number two.
The roadmap
From first conversation to first patient enrolled
A structured programme with defined deliverables at every stage. You always know what is being built, who owns it, and what happens next.
Most clinics reach study-ready in three to six months, depending on staffing, space and therapeutic area. We tell you which of those is your constraint in the first two weeks.
-
01
Assess
Site feasibility assessment, patient population and EHR analysis, therapeutic-area fit, gap analysis against GCP, and a written business case with realistic revenue modelling.
Feasibility reportGap analysisRevenue model -
02
Build
SOPs and quality system, regulatory registrations, equipment and storage validation, eRegulatory and CTMS selection, and a fully trained, credentialed research team.
SOP libraryIRB & FWATeam training -
03
Launch
Capabilities profile and site registrations, targeted sponsor and CRO outreach, feasibility responses, budget and CTA negotiation, and support through your first site initiation visit.
Site profileSponsor outreachBudget & CTA -
04
Grow
Enrolment performance management, monitoring and audit readiness, protocol deviation and CAPA support, and a pipeline strategy that turns one study into a standing portfolio.
Enrolment KPIsAudit readinessStudy pipeline
Health equity
The trials that need your community most are the ones least likely to reach it.
Clinical trials have historically clustered around a small number of academic centres, which means the patients enrolled rarely look like the patients who will eventually take the drug. Regulators have stopped treating that as acceptable, and sponsors are now accountable for who they enrol.
That shift makes community clinics — particularly those serving rural, immigrant, Black, Hispanic and low-income populations — genuinely valuable to sponsors for the first time. If your practice sits in an underserved area, your patient panel is not a limitation. It is the reason a sponsor should choose you.
We help you make that case in the language sponsors use, and then build the trust, access and language infrastructure that makes the enrolment real rather than aspirational.
Where representation is built
- Community, faith and patient-advocacy partnerships that precede the first protocol
- Translated materials and consent processes with qualified interpretation
- Visit design around real lives — transport, childcare, working hours, stipend structure
- Trial-literacy education that addresses well-founded historical mistrust honestly
- Enrolment reporting that evidences your contribution to a sponsor's Diversity Action Plan
Who we work with
Built for the site that hasn't started yet
Our work is designed for organisations with clinical strength and no research history — and for sites that started, stalled, and need the foundation rebuilt properly.
Independent & group practices
Primary care, internal medicine, cardiology, endocrinology, psychiatry, dermatology, rheumatology, OB-GYN and beyond.
Community & safety-net clinics
FQHCs and community health centres serving the populations that clinical research has consistently missed.
Hospitals & health systems
Regional systems standing up a research department, or unifying scattered investigator-led activity under one quality system.
Stalled & one-and-done sites
Sites that ran a study, struggled with enrolment or findings, and need the operation rebuilt before sponsors return.
Nearly a thousand years ago, Avicenna wrote down the rules for testing a treatment before believing in it.
Ibn Sīnā (Avicenna), The Canon of Medicine, c. 1025 — an early articulation of the principles behind the controlled clinical trial. We took the name because that is still the whole job.
Common questions
What clinics ask us first
Three to six months is typical for a clinic starting from zero, and the constraint is almost never paperwork — it is staffing and space. Building the quality system, registrations and training runs in parallel with sponsor outreach, so you are being evaluated for studies while the infrastructure is still being finished. We give you a candid timeline after the feasibility assessment, including the case where the honest answer is "not yet."
No. Most sites begin with one principal investigator and one coordinator — often an existing nurse or medical assistant we train and credential — with regulatory and quality functions supported by us until study volume justifies a dedicated hire. We help you sequence hiring against actual contracted revenue rather than hope.
Sponsors pay a negotiated per-patient budget covering procedures, staff time and overhead, plus startup fees, screen-failure payments and pass-through costs. Margin lives almost entirely in the budget negotiation and in enrolling the patients you committed to. We build the financial model with your real cost basis during the assessment phase, and we negotiate the budget and clinical trial agreement with you — including the Medicare billing compliance and coverage analysis questions that create risk if handled loosely.
It changes workflow, and pretending otherwise is how sites fail. Research visits are longer, more procedural and documented to a different standard than clinical care. We design the visit workflow, space allocation and scheduling around your existing clinic rather than on top of it, and we are deliberate about which studies to accept in year one so the operational load matches your capacity.
You should expect sponsor monitoring visits from the start, and an FDA BIMO inspection is a real possibility once you have enrolled meaningfully. Everything we build is designed backwards from that day: contemporaneous source documentation, a maintained delegation log, complete training and regulatory files, and documented CAPA for deviations. We run internal audits and mock inspections before anyone else does, and we support you through the real thing.
Frequently the opposite. Sponsors are under regulatory and commercial pressure to enrol representative populations, and the large academic centres they have always used are saturated and competing for the same patients. A well-run community site with an engaged, under-recruited panel and genuinely faster startup is a compelling proposition — provided the compliance story is airtight, which is precisely what we build.
Start here
Find out whether your clinic is ready — before you spend a dollar on it.
A 30-minute readiness call covering your patient population, therapeutic areas, staffing and space, with a straight answer about what standing up research would actually take.