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Clinical research consulting that keeps your site ready for the FDA inspection, the monitoring visit, the sponsor audit and the IRB review.

Modeli Research Consultants works alongside clinical research sites from start-up to close-out. Audits, regulatory, quality control, budgets and training, so your team runs every study with confidence.

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  • Led by an RQAP-GCP and ACRP-CP certified consultant
  • Society of Quality Assurance member with IRB experience
  • On call for your site, built for long-term partnership

Every engagement is built around the regulations your site is inspected against, for drug, biologic and medical device trials.

ICH E6(R3)ISO 1415521 CFR Part 1121 CFR Part 5021 CFR Part 5421 CFR Part 5621 CFR Part 31221 CFR Part 81221 CFR Part 81445 CFR 46HIPAAALCOA+FDA BIMOOSHA

What MRC delivers for your site

  • Reduce findings.
  • Research with confidence.
  • Build lasting relationships with CROs and sponsors.

Sites that close findings fast, document cleanly and run studies consistently are the sites sponsors come back to. That is the site we help you become.

See how we help

Built by people who've worked at the site level.

MRC was built by people who have worked inside research sites. We've been audited by sponsors, broken down complex protocols into workable visit plans, prepped for monitoring visits, reconsented subjects and pushed back on budgets that didn't cover the work. When we step into your site, we already see it the way your team does.

Meet our leadership

A day at your site. We've worked every hour of it.

  1. Sponsor auditors arrive for a two-day site audit

  2. Subject reconsented on the new ICF version

  3. Complex protocol amendment broken down into visit checklists

  4. Sponsor counter-offer lands on the study budget

  5. Labs and AEs reviewed and signed by the investigator

  6. Binder reconciled before day two of the audit

Services

Bring us in for a single project or as an extension of your team. Every service can be scoped to one study or your whole site.

Audits and quality assuranceFind the issues before a sponsor or the FDA does, with risk-based internal audits, source QC and CAPA plans that close findings. Regulatory managementRegulatory files kept current on site or remotely, so coordinators can focus on screening and enrollment. Budgets and contractsBudgets and contracts negotiated to fair market value, so every visit and procedure is paid for. eSource and CTMSFull eSource implementation, source creation and site training, or ongoing builds for sites already on eSource. Training and SOPsSOP gap analysis or a complete new package, plus training tailored to your site, from GCP and ALCOA+ to inspection readiness. Site start-up and consultingStart-up support, strategies for winning studies, and HIPAA, FDA and OSHA compliance.

The Modeli guarantee.

When the FDA notifies your site of an inspection, call us. We will make our best efforts to be at the inspection to support your team, starting as soon as we're notified.

We've done it before. When a client received notice just three days out, we cleared our schedules and were on site with their team.

Get inspection ready

  1. FDA inspection notice arrives

  2. You call MRC

  3. We clear our schedules

  4. We work to be on site with your team

How we start working together

  1. 1

    Consultation

    We learn about your site, your studies and what you need most right now.

  2. 2

    Site assessment

    We review your processes, documents and open findings, and show you where you stand.

  3. 3

    Proposal and agreement

    A clear proposal with scope and fees. Our master service agreement covers confidentiality from day one, and each project gets its own statement of work.

  4. 4

    Ongoing partnership

    We stay on call through monitoring visits, audits and inspections, for as long as you need us.

What site owners say

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Client resource library

MRC clients sign in to download templates, training materials, SOP guidance and every edition of our newsletter.

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  • Regulatory updates
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The MRC newsletter

Regulatory updates, conference takeaways and lessons from the field, written for research sites.

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Better together.

Tell us where your site needs support. We'll talk it through and show you how we can help.

Book a consultation
(786) 383-6661simon@modeliresearch.com