Skip to content
Emergent Healthcare

Site Management Organization (SMO) Services

The whole operational layer of a research site — staffed and run by us.

A research site carries everything a busy practice carries, and a protocol on top of it. We provide clinical trial site support services across that whole operational layer — clinical research site management from the first regulatory package through to the last query resolved. Our independence is deliberate: we hold no oversight role in any study, so the one thing we answer for is your site running well.

  • Site Support
  • Hourly to Full-Time
  • No Oversight Role

Meet the team · 1 min

Valeria Lazo

Clinical Research Team Lead

  • How we run the operational layer of your site
  • Why our independence protects your study
  • HIPAA compliance, audited and verified

The problem we solve

A site runs on people who are already at capacity

  • Coordinators stretched across protocols

    One CRC covering three studies is how queries pile up and visits slip.

  • Start-up that never starts

    Regulatory packages and IRB submissions waiting on someone with time to chase them.

  • Participants who drift away

    Retention is lost between visits, not during them.

What's included

One division, the whole operation

Clinical Research Coordinator Staffing

Coordinators and data managers, on site or remote, contracted by the hour, by the day or full time — trained for your protocol and supervised daily.

  • CRCs on site or remote
  • Hourly, daily or full-time contracting
  • Data managers and EDC data entry
  • Queries answered as they come in
Learn more

Outsourced Clinical Research Coordinators, On Your Terms

An outsourced CRC arrives trained for your protocol, supervised by us daily, and scaled to the study — a few hours a week for a follow-up study, full time for an enrolling one. When enrollment closes, the hours scale down with it, and you never carried the hire.

Replaces: hiring a full-time CRC for a part-time need. Ask about this

Study Start-Up Services & IRB Submissions

Site activation with the regulatory package tracked through to approval, and IRB submissions prepared, filed and followed until they clear.

  • Study start-up and site activation
  • IRB submissions prepared and followed
  • Investigator and coordinator training coordinated
  • Credentials tracked and current
Learn more

IRB Submission Support, Filed and Followed

Initial submissions, amendments, continuing reviews and safety reports prepared in the format your IRB expects — then tracked until the approval letter is in the regulatory binder. Nothing waits on someone finding time to chase it.

Replaces: activation timelines that slip by months. Ask about this

Budgets, Contracts & Research Billing Compliance

Budget development and clinical trial agreement negotiation with sponsors and CROs, plus coverage analysis reviewed protocol by protocol.

  • Budget development and CTA negotiation
  • Coverage analysis and research billing compliance
  • Invoicing, receivables and participant stipends
  • CTMS study build and day-to-day support
Learn more

Clinical Trial Budget Negotiation

Budgets built from your site’s real costs — coordinator time, procedures, overhead, invoiceables — and negotiated with sponsors and CROs line by line. Under-negotiated budgets are the quietest way a site loses money; ours come back covering what the work actually costs.

Research Billing Compliance Services

Coverage analysis reviewed protocol by protocol, so every item is billed to the right payer — sponsor, insurance or patient — and nothing lands twice. The audit trail is built as the study runs, not reconstructed when someone asks for it.

Replaces: revenue lost to under-negotiated budgets. Ask about this

Patient Recruitment Services for Clinical Trials

Participant identification, pre-screening and enrollment outreach — then retention across the full study calendar.

  • Participant identification and pre-screening
  • Enrollment outreach
  • Visit reminders, travel and adherence follow-up
  • Safety letter distribution, documented every time
Learn more

Retention Across the Full Study Calendar

Identification from your own patient population first, pre-screening against inclusion criteria, and outreach in the language each candidate actually speaks. Then retention — visit reminders, travel coordination and adherence follow-up — because a participant lost at month six costs more than one never enrolled.

Replaces: enrollment targets missed quarter after quarter. Ask about this

Site Operations, Documentation & Audit Readiness

The day-to-day operational layer that keeps a site inspection-ready — and the study pipeline that keeps it growing.

  • Source documentation kept complete and current
  • Monitoring visit coordination and follow-up
  • Continuous audit and inspection readiness
  • Study identification: your site matched to sponsor and CRO opportunities
Learn more

Replaces: the scramble before every monitoring visit. Ask about this

Who uses this division

  • Oncology
  • Cardiology
  • Neurology
  • Endocrinology
  • Rheumatology
  • Infectious Disease
  • Research sites · Sponsors · CROs

Guaranteed in the contract

The numbers this division answers for

  • FIRST-CONTACT RESOLUTION

    0%

    Industry 68%95% guaranteed

  • PATIENT SATISFACTION

    0/5

    Industry 3.8/54.9/5 guaranteed

  • PATIENT FOLLOW-THROUGH

    0%

    No industry benchmark100% guaranteed

FROM SIGNATURE TO RESULTS

How we go on call for your practice

  1. 01

    Free consultation

    We go through your call volume, your current numbers, your languages and your hours. No cost and no commitment.

  2. 02

    Transition

    We coordinate with your current team, your systems and your insurers. Someone calling on the day of the switch hears the same warm voice they always did.

  3. 03

    Reporting

    Daily oversight, and a monthly report showing exactly how many patients were reached.

FAQ

Before you ask — answered

What is a site management organization (SMO)?

An organization that provides the operational staff and processes a research site needs to run studies: coordinators, data management, regulatory submissions, budgets and participant follow-up — without taking any oversight role in the study itself.

What is the difference between an SMO and a CRO?

A CRO works for the sponsor and monitors the study. An SMO works for the site and runs its operation. We deliberately hold no oversight role in any study, so the one thing we answer for is your site running well — there is no conflict of interest.

Do you take any oversight role in our studies?

No, and that is deliberate. We hold no monitoring, CRO or sponsor role in any study we support, so there is never a conflict between overseeing your work and doing it. The one thing we answer for is your site running well.

How much do SMO services cost?

It depends on which layer you contract — a part-time coordinator costs very differently from full site management. The model is built to scale: hourly, daily or full time, per study or per site. The free consultation maps your studies and returns specific numbers.

Can we contract a coordinator by the hour?

Yes. Coordinators and data managers can be contracted by the hour, by the day or full time, on site or remote, so a part-time need does not require a full-time hire.

How quickly can a coordinator start?

Typically within weeks, including protocol training. For an enrolling study that cannot wait, we phase the start: the coordinator begins on the urgent workload while completing training on the rest.

Do you work with our existing CTMS and EDC?

Yes. We build and maintain CTMS studies and handle EDC data entry in the systems your sponsors require.

Can you help our site find new studies?

Yes. Study identification is part of the division: we match your site’s specialties, patient population and track record to the sponsor and CRO opportunities that fit it, and support the feasibility responses that win them.

NEXT STEP

Put this division on call for your practice.

Somewhere in your waiting room there is a patient who found you because the phone was answered. Let’s talk about how to make that every patient. Free, personalized, and no commitment.

A member of our team replies directly, usually the same business day.

Free · Personalized · A member of our team replies directly, usually the same business day.

Site Management Organization (SMO) Services | Emergent Healthcare