Inflammatory bowel disease · Crohn's & ulcerative colitisRecruitment methods · No. 01
For IBD research coordinators · Crohn's & ulcerative colitis

The fastest way to understand trial eligibility and organize screening.

One workflow, done properly: read a Crohn's or ulcerative colitis protocol, write its eligibility out so the whole team reads it the same way, and work through your screening list in a sensible order. It starts with the documents and lists your team already keeps.

Built for
IBD research coordinators
Scope
Eligibility and screening, done properly
Record access
None required to start
Worked exampleSynthetic data

Phase III Protocol — Moderate-to-Severe Crohn's Disease

84 pages · sample document

Age 18–75Endoscopically confirmed CDPrior biologic failure
iProtocol receivedCD-3021_crohns_protocol.pdf
iiCriteria extractedCDAI & SES-CD, with clause refs
iiiProfiles ranked18 candidate profiles supplied
ivEnrollment planned10-month projection

Fig. 1Worked example: a fictional Phase III Crohn's protocol resolved into eligibility criteria. Document, counts, and timeline are synthetic.

Abstract

Why a tool for one disease area rather than all of them.

Recruitment software that covers every therapeutic area tends to model eligibility as a flat list of inclusion and exclusion strings. IBD does not behave that way. Disease activity is composite and index-dependent, endoscopic scoring is centrally read and often the rate-limiting step, and prior-therapy language carries clinical meaning that a keyword match discards. A general tool loses precisely the details that decide whether a candidate is worth a screening visit.

TrialFlow is narrow on purpose. It encodes the vocabulary of Crohn's disease and ulcerative colitis — CDAI and its subscores, SES-CD, the Mayo score and its endoscopic component, disease extent and duration, biologic and immunomodulator exposure, corticosteroid dependence — and treats each as a structured, checkable field rather than text.

Nothing here runs on its own. Every reading is a draft until a person on your team accepts it, every score shows the reasoning behind it, and we hold no hospital records. The figures on this page are worked examples built from invented data.

Observations

Three things that make IBD recruitment behave differently.

Obs. 1

Eligibility in IBD is written for adjudication, not for screening

A single moderate-to-severe Crohn's protocol can carry a CDAI window, an SES-CD threshold, a stool-frequency and abdominal-pain subscore floor, a corticosteroid taper rule, and three separate prior-biologic clauses. They sit in different sections, written in different registers, and two coordinators reading the same document reach different shortlists.

Obs. 2

Screen failure in IBD arrives late and expensive

Because central read of endoscopy is the gating step, an ineligible candidate is often identified after the scope has been done and read. The cost is not only the procedure; it is the coordinator hours, the scheduling slot, and the participant's willingness to be approached again.

Obs. 3

Most screening time is spent restructuring information

Scope reports, biologic exposure histories, calprotectin and CRP panels, and taper records are reconciled by hand into a working note. The clinical judgement takes minutes. Assembling the material to support it takes hours.

Method

Three components, each one inspectable.

Reading the protocol, reviewing candidates, and watching enrollment — built so your team can check the working, not just the answer.

I

Protocol Reading

Someone has to sit down with a Crohn's or UC protocol and write out what it actually asks for: activity indices and their windows, endoscopic thresholds, prior-therapy rules, exclusions. We do that work with you, and every line points back to the clause it came from so you can check our reading before you trust it.

How it works
II

TrialFit

Candidate profiles your team puts in are compared against that reading. Each one comes back with what it met, what it did not, and the one thing a coordinator should check next. A number without the reasoning behind it is not much use to anyone.

How it works
III

Recruitment Analytics

Enrollment against plan, how each GI site is doing, and why screens are failing. The point is to notice the pattern early enough to do something about it, while the study is still open.

How it works
Component I

Protocol Reading

A protocol comes in as a document and comes out as a plain list of what it asks for: activity windows, endoscopic thresholds, prior-therapy rules, exclusions — each one traceable to the sentence it came from.

01Source documentCD-3021_crohns_protocol.pdf · 84 pp.
02Criteria written outCDAI, SES-CD and Mayo criteria in one format
03Draft for review31 criteria · clause references kept
04Study team sign-offDraft until a person accepts it
Fig. 2Sequence for a synthetic Crohn's protocol. Counts and file names are illustrative.
Component II

TrialFit

Candidate profiles are compared against the eligibility your team signed off on. The reasoning sits beside the score, along with the one thing a coordinator should check next.

Demo Data

Sarah M.

Site 004 — Northside GI

Demo Data
Match score96%

Basis for the score

  • Ileocolonic Crohn's disease, endoscopically confirmed
  • CDAI 312 — within moderate-to-severe window
  • Documented anti-TNF inadequate response
Verify next: Confirm fecal calprotectin and CRP are within the screening window

Emily R.

Site 002 — Lakeview IBD Center

Demo Data
Match score93%

Basis for the score

  • Ulcerative colitis, left-sided extent
  • Mayo endoscopic subscore of 2
  • No biologic exposure — meets naïve cohort
Verify next: Verify corticosteroid taper history before pre-screening call

David K.

Site 007 — Riverbend Gastroenterology

Demo Data
Match score91%

Basis for the score

  • Crohn's disease with steroid dependence
  • Disease duration over 6 months at screening
  • Stable follow-up record at the IBD clinic
Verify next: Review prior bowel resection date against exclusion criteria

Fig. 3Fictional candidate profiles. Names, sites, and scores are invented for demonstration — no real patient record is represented here.

Component III

Recruitment Analytics

Enrollment against plan, throughput by GI site, and the shape of screen failure — measured so recruitment strategy can change while the study is still running.

Enrollment against plan

Sample Crohn's study CD-3021

Demo Data

72%

of the planned enrollment target

10 mo

projected completion

Recruitment projection

Modelled on synthetic data

Demo Data

Notes on the data

Read from the synthetic series above

Demo Data
  • Two sites screen at volume without matching enrollment, which is consistent with the SES-CD threshold being read inconsistently between readers.
  • The exclusion count is high relative to comparable sample IBD protocols, driven mainly by the prior-biologic clauses.
  • On this synthetic series, outreach capacity moved toward Lakeview would recover roughly a month of timeline.

Fig. 4Synthetic enrollment series for a fictional multi-site Crohn's study.

Procedure

What a study team actually does, in order.

  1. Step 01

    Protocol is loaded

    The study team uploads the Crohn's or ulcerative colitis protocol into a private workspace. Nothing leaves it.

  2. Step 02

    Eligibility is written out plainly

    Activity indices, endoscopic thresholds, therapy history, and exclusions are laid out one by one, each with the clause it came from sitting next to it.

  3. Step 03

    The team reads it, corrects it, and signs off

    It stays a draft until someone on your team says it is right. Every edit is kept, and the version you accepted is the one candidates are compared against.

  4. Step 04

    Candidates and enrollment are reviewed together

    Ranked profiles and site-level enrollment metrics inform where outreach effort goes next. The decision stays with the investigator.

Worked example

The workspace, as a study team would see it.

A static walkthrough of the console using a fictional Phase III Crohn's disease study.

TrialFlow workspace

Worked example

Protocol Reading

Populated with a fictional IBD study for demonstration.

Study

IndicationCrohn's Disease
PopulationModerate-to-severe
PhasePhase III
DocumentCD-3021_crohns_protocol.pdf

Eligibility

Age 18–75 at screening

Endoscopically confirmed CD ≥ 3 months

CDAI 220–450 with SES-CD ≥ 6

Inadequate response to a biologic or immunomodulator

Exclusions

Bowel resection within 6 months

Ostomy or short bowel syndrome

Active abdominal abscess or C. difficile

Isolated perianal-only disease

Output status

Showing a pre-generated summary. Nothing is uploaded or processed here.

Worked example — a static preview of the workspace. It does not connect to hospital records and does not process real patient data.

Fig. 5Interface preview. Not a live system; no records are queried.

Correspondence

If you run IBD studies, we would rather hear what breaks than pitch you.

Tell us about the protocol you are screening against and where the screening effort actually goes. We will walk through the three components against your example.