The protocol is the backbone of every clinical trial. It should be digital.

Concordare turns your study design PDFs into a digital format and generates the full study ecosystem, including EDC builds, CTMS configurations, billing grids, source documents, and more.

Every clinical trial comes with a stack of documents.

What if you digitized them?

Generate source documents instantly.

Scroll through visits, each one generated from the same CTPM.

Different study? New protocol-specific CTPM generated. Same instant output.

But source documents are just the beginning.

Build your EDC automatically. Forms, fields, validation rules, all derived from the same model.

Still the same CTPM. Still more to generate.

Populate your CTMS from day one. Milestones, site setup, visit schedules are all structured and ready to load.

Extract once. Generate everything.

Your team reviews and validates the model. Nothing ships without human approval.

eCRF Completion Guidelines

Manuals

Clinical Trial Protocol Model

.CcTtPpMm

.ctpm

{{institution_name}}Harbor Health Medical CenterHarbor Health Medical Center

{{study_title}}Phase 2 Study of XYZ-101 in Metastatic Breast CancerSafety and Efficacy of CRD-485 in Heart Failure

{{protocol_no}}XYZ-101-002CRD-485-PH3

{{pi_name}}Dr. Sarah ChenDr. Marcus Patel

{{sponsor}}Concordare TherapeuticsConcordare Biosciences

{{visit_name}}ScreeningCycle 1 Day 1Screening

{{visit_window}}Day -28 to -1Day 1Day -21 to -1

Informed ConsentWitnessed signature requiredYesNo

Medical History ReviewPrior therapies, comorbiditiesYesNo

Physical ExaminationECOG performance statusYesNo

Tumor Imaging, CTBaseline lesion measurementYesNo

Blood Draw, HematologyCBC with differentialYesNo

Vital SignsPre-dose baselineYesNo

Blood Draw, ChemistryCMP, LFTs, electrolytesYesNo

Pregnancy TestUrine, women of childbearing potentialYesNo

Study Drug InfusionMonitor for infusion reactionsYesNo

Post-dose VitalsEvery 15 min for 1 hourYesNo

Informed ConsentCardiology specific risksYesNo

NYHA ClassificationClass II or III requiredYesNo

EchocardiogramBaseline ejection fractionYesNo

Blood Draw, BNPPro-BNP for inclusionYesNo

ECG, 12-leadRhythm and intervalsYesNo

Safety and Efficacy of CRD-485 in Heart Failure

Demographics

Vital Signs

Adverse Events

Medical History

Concomitant Meds

Lab Results

Study Drug

Subject IDText

Visit DateDate

Systolic BPNumeric

Diastolic BPNumeric

BNP LevelNumeric

InvestigatorText

Adverse EventsLog Form

Concomitant MedsLog Form

AE TermText

Onset DateDate

SeverityText

OutcomeText

Related to Study Drug?Text

Action TakenText

Resolution DateDate

Concomitant MedsLog Form

42 forms

186 fields

12 edit checks

Safety and Efficacy of CRD-485 in Heart Failure

Procedure	Scr	C1D1	C1D15	C2D1	EOT	Total
Informed Consent	$150					$150
Vital Signs	$45	$45	$45	$45	$45	$225
CBC w/ Diff	$85	$85		$85	$85	$340
CMP	$95	$95			$95	$285
CT Imaging	$1,200			$1,200	$1,200	$3,600
ECG 12-lead	$250				$250	$500
Study Drug		$0	$0	$0		$0
AE Assessment		$75	$75	$75	$75	$300
Total	$1,825	$300	$120	$1,405	$1,750	$5,400

Visit Procedure Worksheet

Study

Protocol No.

Sponsor

Visit

Visit Window

ProcedureNotesCompleted

CRC Initials: ________Date: ________Time Completed: ________

Your EDC

Forms7

Fields+ Add field

All validations passing

Your CTMS

Study /

Schedule of Events & Costs

Last sync: 2 min ago·

Healthy

Research staff juggle protocols, lab manuals, pharmacy manuals, imaging manuals, eCRF guidelines, all describing the same trial in different formats.

Conversion

Convert your study design documents into the CTPM (Clinical Trial Protocol Model) digital format using Apta, our AI-powered conversion engine.

Source documents

Every visit and procedure populated directly from your CTPM. Visit-by-visit worksheets, ready to print or push to your EDC.

Any visit

Same model for every visit. No manual rework. Screening, treatment, follow-up, all ready for your coordinator.

Any study

Any therapeutic area, any protocol design, any sponsor. One workflow.

More outputs

The CTPM doesn't stop at source document generation.

EDC build

The database is generated from the CTPM rather than built independently. Because the EDC and your source documents come from the same source, they stay aligned by default.

Same model

One CTPM. Two outputs. More to come.

CTMS populated

Site activation in hours, not days.

Human in the loop

Every CTPM is reviewed and validated by your team before a single output is generated. AI extracts. Humans approve.

Trial Documents

Protocol · eCRF Guidelines
Manuals

Source Documents

EDC Build

CTMS Config

The Clinical Trial Protocol Model is your single source of truth. Built by Apta, used by your entire operation.

The impact

Without Concordare

Lengthy average study startup

With Concordare

6-8 weeks saved

Without Concordare

Hours spent building each EDC by hand

With Concordare

Generated in minutes from the CTPM

Without Concordare

Manual source doc creation per visit

With Concordare

Instant. Every visit, every study

Without Concordare

Error-prone manual data entry

With Concordare

Significantly reduces mistakes

Are you a Site, CRO, or Sponsor?

Concordare can build and generate documents no matter which side of the study ecosystem you are on

I am a

Site Sponsor or CRO