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REDCap Database Build Services

REDCap Database Build

Pubrica designs and builds REDCap databases for academic trials, clinical research units, registries, multi-site studies and research groups. Our database builders and statisticians design each project around the analysis dataset from the first field, which is the stage at which design decisions cost least. Deliverables include a protocol-based data model, instruments with validation and branching logic, configured randomisation, surveys, e-Consent and Data Access Groups where required, user acceptance testing and a version-controlled data dictionary. A well-designed build avoids the common problems of free-text fields where coded fields were needed, missing validation and branching, inconsistent date formats and an undocumented data dictionary, all of which add to cleaning costs at analysis.

  • Database design based on the analysis, because field types, coding and structure determine how much data cleaning is needed later
  • Validation and branching logic built in, so that invalid data is rejected at entry rather than found at database lock
  • Data dictionary as a core deliverable, version-controlled so that the project can be rebuilt, audited or transferred
  • Randomisation, surveys, e-Consent and Data Access Groups configured where the study design requires them
  • Accurate guidance on 21 CFR Part 11: REDCap can be configured to support it, but compliance is the responsibility of the institution running the instance, not of the software
Get a free quote Deliverables
What a REDCap Build Covers What is included and what is excluded

Data dictionary designed and deliveredIncluded

Validation and branching logicIncluded

Randomisation and survey setupIncluded

Query and data quality workflowIncluded

Certifying your instance as Part 11 compliantOnly your institution can do this

Protocol → dictionary → built → tested → in production

Included in every build
  • Database designed from the analysis plan
  • Validation at data entry
  • Version-controlled data dictionary delivered
  • User acceptance testing before go-live
  • Clear guidance on Part 11 responsibilities
Quoted per projectBased on form count and study design
Dictionary deliveredVersion-controlled and portable
Exports testedTo R, SAS, SPSS and Stata
ISO 9001:2015Certified quality management system · cert. H3CR9TCU20251212INDQM10N

Service Scope

Four REDCap Database Build Service Areas, Available Individually

Pubrica offers each part of its REDCap database build service separately, because clients come to us at different stages, from initial study design to databases already collecting data.

Instrument design from the protocolWe build forms from the schedule of assessments rather than from an existing spreadsheet, so that the data collected matches what the protocol states will be analysed.
Validation, branching and calculated fieldsWe configure field types, ranges, required fields, branching logic and calculations so that invalid data is difficult to enter rather than discovered at database lock.
Longitudinal events, arms and randomisationWe configure and test event definitions, arm structure, repeating instruments and the randomisation module against the protocol’s schedule.
User roles, audit trail and exportWe set up Data Access Groups and role-based permissions, confirm the audit trail, and build export specifications that produce the analysis dataset in the format the statistician requires.

Who We Serve

Research Teams and Organisations We Support with REDCap Database Builds

We support academic investigators, clinical research units, registries, multi-site consortia, doctoral researchers and quality improvement teams.

Academic and investigator-led trialsA database built to the required standard without a commercial EDC budget, by builders experienced in REDCap.
Clinical research units and CTUsAdditional build capacity, or an independent review of a build before the first patient is enrolled.
Registries and cohort studiesLongitudinal structures, repeating events and export specifications designed to remain usable over many years of follow-up.
Multi-site and consortium studiesData Access Groups, site-level permissions and a structure that remains consistent when several teams work on it.
Doctoral scholars and research groupsA database that produces an analysable dataset, avoiding weeks of spreadsheet cleaning.
Quality improvement and audit teamsStructured data capture with an audit trail, replacing shared spreadsheets.

Deliverables

What Every REDCap Database Build Includes

A study database should be designed around the analysis it will support. Design errors are inexpensive to correct early and costly to correct after data collection.

Database design based on the analysis The statistical analysis plan, or at least the primary endpoint, determines field types, coding and structure, rather than the order of questions on the paper form.

Example from a design reviewBlood pressure: [ text field ]Systolic and diastolic as separate integer fields with range validation, plus position and cuff size as coded fields. A single text field would require hours of cleaning and leave entries such as “140/90 sitting” ambiguous.

Validation and branching at entry Field-level validation, range checks, required fields and branching logic prevent errors such as a date of birth after the visit date or a pregnancy field completed for a male participant.

Example from a buildEvery check not built into the database becomes a query raised later, with a cost per query and a coordinator trying to recall a visit from months earlier.

Data dictionary as a core deliverable Delivered as a versioned file, so that the project can be rebuilt on another instance, audited, passed to a statistician or restored if a live form is edited.

Example from a handoverA REDCap project that exists only on one institution’s server, without an exported dictionary, cannot be transferred, reproduced or defended.

Accurate description of Part 11 requirements REDCap supports the features a Part 11 environment needs, including audit trail, e-signature and user access control. Whether your instance is compliant depends on how your institution validated, configured and documented it.

Example from a scoping callA claim that REDCap “is Part 11 compliant” is inaccurate and may lead to audit findings. Software itself is not compliant; compliance applies to a validated system operated under documented procedures.

The samples shown are illustrative and anonymised. Hover over a sample to replay it.

Compliance and Standards

Regulatory and Data Standards for REDCap Databases

In a regulated study, the database forms part of the regulated system.

Part 11

Electronic records and signatures (FDA, with the Oct 2024 guidance)

Audit trail, access control, e-signature and system validation. These obligations apply to the organisation operating the system, so the institution’s validation documentation is more important than the software used.

E6(R3)

Good clinical practice (data governance)

The R3 revision places data governance and the reliability of electronic systems at the centre of GCP, and these are the standards against which a study database is assessed.

CDASH (collection standards)

Designing collection fields to CDASH from the start makes later SDTM mapping straightforward. Retrofitting CDASH after collection is more costly, although it is the common approach.

ISO9001:2015

Quality management (cert. H3CR9TCU20251212INDQM10N)

Our certified quality system governs how work is run, recorded and released.

Responsible Use of AI

Responsible Use of AI with Every Configuration Tested

AI-generated field definitions and branching logic can appear correct while failing without warning. An incorrect branch can result in a year of missing data that is only discovered at analysis.

How We Use AI ToolsWe use AI tools to draft a first-pass data dictionary from a protocol, which a specialist then checks field by field against the schedule of assessments, and to identify inconsistencies between the protocol, the CRF and the analysis plan.
Where We Do Not Use AINo configuration is accepted without testing, no validation rules or branching logic are released untested, and randomisation setup is always checked by a second person.
What Your AI Declaration Should IncludeYour declaration states the tool, the stage at which it was used and the human oversight applied. Journals, funders and the ICMJE January 2026 update now expect this, and an undeclared tool found later is treated as a research integrity matter.

Why We Do Not Publish AI Accuracy Figures

Accuracy figures for AI tools are usually reported by the companies that sell them.

Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.

Our Process

How Our REDCap Database Build Process Works

We start from the protocol and the analysis plan. A database built from the case report form alone often produces data that cannot be analysed as planned.

Step one

Design

We review the protocol and endpoints, design the data model, and decide field types and coding according to how each variable will be analysed.

Step two

Build

We build the instruments, validation, branching logic and calculated fields, together with the modules the design requires, such as randomisation, surveys, e-Consent and Data Access Groups.

Step three

Testing

User acceptance testing with the people who will use the database, including entering and exporting test records and checking the export in your analysis software.

Step four

Handover

We export and version the data dictionary, provide a short written guide for coordinators, and agree the query workflow before the first participant is entered.

Our Experts

Your REDCap Database Build Team

A named team of database builders, statisticians and subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.

Subject matter expertClinical or scientific expert matched to your topic

Reviews the scientific content for accuracy and confirms that each conclusion is supported by the evidence. Each expert is matched to your field of research.

Responsible forScientific accuracy and interpretation
Reviews againstThe study protocol and current literature
FieldMatched to your topic
BiostatisticianStatistical input where the work reports analysed data

Checks that statistical methods, tables and conclusions are consistent with the analysis plan and that the analysis can be reproduced.

Responsible forStatistical accuracy
Reviews againstICH E9 and the statistical analysis plan
ToolsR, SAS, Stata, Python
Data specialistData handling, cleaning and documentation

Prepares, cleans and documents the data so that every step from raw data to final output can be traced and reproduced.

Responsible forData handling and documentation
Reviews againstThe data management plan and applicable data standards
OutputDocumented, reproducible datasets
Second reviewerIndependent check of code and outputs

Independently checks code, tables and outputs against the analysis plan. Discrepancies are logged and resolved before delivery.

Responsible forIndependent quality control
Reviews againstThe analysis plan and outputs
Signed off byProject lead

Packages

REDCap Database Build Packages

The cost depends on the number of instruments, the complexity of the visit schedule and whether the study is regulated.

Build

Study database build

For a new project

Quoted per projectBased on instruments and visit schedule

Delivery Quoted by scope

  • ✓Data model designed from the analysis
  • ✓Instruments built with validation and branching
  • ✓Longitudinal events and arms configured
  • ✓User acceptance testing
  • ✓Dictionary exported and versioned
  • ✓Coordinator guide written

Please send the protocol and the analysis plan. We can build from a blank CRF, but this costs more.

Deliverables Request a quote
Trial

Interventional study setup

For studies with randomisation or consent in the system

Quoted per projectBased on design and regulatory context

Delivery Quoted by scope

  • ✓Everything in the study database build
  • ✓Randomisation module configured and tested
  • ✓e-Consent framework set up
  • ✓Data Access Groups for multi-site studies
  • ✓Query and data resolution workflow
  • ✓Documentation for your validation file

We produce documentation your institution can use in its validation file. We do not certify your instance, as only your institution can do so.

Deliverables Request a quote
Existing project

Existing project review and repair

For a database already collecting data

Quoted per projectBased on what can be changed mid-study

Delivery Quoted by scope

  • ✓Current structure and dictionary reviewed
  • ✓Analysis risks identified
  • ✓Changes that can be made safely mid-study separated from those that cannot
  • ✓Validation added where data already exists
  • ✓Cleaning plan for what is already collected

Some issues cannot be corrected once data collection has started. We will tell you which these are, rather than make a change that disconnects your existing records.

Deliverables Request a quote

Send us your protocol and we will review your data model or existing dictionary at no cost and identify where it is likely to cause problems at analysis.

Benefits

Benefits of a Pubrica REDCap Database Build

Four reasons research teams commission a REDCap build from us.

01Data validated at entryValidation, branching and calculated fields move data cleaning from the end of the study to the point of entry, where it costs least.
02Designed for the analysisThe export specification is designed around the planned analysis, so the statistician receives a dataset that does not need restructuring.
03Audit-ready configurationRoles, permissions and the audit trail are configured and documented, which is what monitors, sponsors and ethics committees ask to see.
04Full handover to your teamThe project, the data dictionary and the documentation belong to you, so your team can maintain the database independently.

Quality Assurance

Our Service Commitments and Limitations

Our service terms are set out in full below.

Our revision commitment

Revision Support Within the Agreed Scope

We continue working within the agreed scope until the work meets the requirements we agreed. Our commitment is to complete the work you commissioned rather than to end the engagement with the problem unresolved.

01

Unlimited revisions within the agreed scope

There is no limit on the number of revision rounds and no time limit. If the work does not meet what we agreed, we revise it. Any widening of scope is quoted separately, and we tell you which applies before work starts.

02

Corrections at Our Cost

If the work needs correction because of an error in our build or documentation, we correct it free of charge.

03

Delivery on the agreed date

We quote a date we can meet. If a milestone is at risk, we tell you early.

04

Mutual NDA on request

We sign a mutual NDA at no cost before you send any material, and we are happy to sign your NDA rather than ours.

05

Final decisions remain with you

We advise, give our view and tell you clearly when we disagree, but decisions about what is published in your name are always yours.

9.4/10

Average client rating

From 3,000 responses to Pubrica’s own post-delivery survey, sent to every client at handover between January 2024 and June 2026. This figure comes from our own records.

Service limitations. We cannot guarantee outcomes that depend on others, such as an editor’s decision, a funder’s panel or a regulator’s assessment. Within the agreed scope, we commit to the work itself: completed to the standard described on this page, delivered on the agreed date and corrected at our cost if we made an error.

FAQs

REDCap Database Build FAQs

If your question is not answered here, please ask an expert. No quote is required.

Software alone cannot be compliant or non-compliant. REDCap provides the features a Part 11 environment requires, including audit trail, user access control and electronic signature.

Compliance applies to a validated system operated under documented procedures, and it is the responsibility of the institution running the instance. We produce documentation for your validation file, but we do not state that the software makes you compliant.

In most cases you already have access. REDCap is licensed through the Vanderbilt-led consortium, and most universities and academic medical centres are partner institutions.

We build within your instance. If you do not have one, we will explain your options without selling you infrastructure.

Yes, by designing collection fields to CDASH from the start. This makes SDTM mapping a mechanical process rather than one that requires interpretation.

Please tell us at the design stage if a regulatory submission is possible. Retrofitting CDASH alignment after collection has started is more costly.

Yes, and this is the usual arrangement. We build within your institution’s instance, following your core team’s conventions, and hand the project over to them.

Academic core teams are often limited by capacity, and a build that follows their standards is easier for them to support afterwards.

Related Services

Related Research Services

A study database is one part of the data workflow, and the services before and after it affect its overall cost.

1BEFORE THE BUILDdesign stage

Statistical analysis planDefines what the database must support. Experimental designSample size and study structure.

2AFTER THE BUILDonce data collection begins

BiostatisticsAnalysis and reproducible code. CDISC SDTM and ADaMFor regulatory submissions.

3ALONGSIDE THE BUILDgovernance

Data management planData management plans required by funders. Medical data collectionProtocol-driven data collection.

Request a Free REDCap Data Model Review

We review your data model at no cost, because design errors are inexpensive to correct before data collection and costly at analysis.

Get a free quote Contact us
Get a free quote

Regulations

Check your project against this rule

  1. 1Your work
  2. 2Your details
  3. 3Send
What do you need?

Material you send is held under signed confidentiality, with access limited to the assigned team and encrypted transfer. It is not used to train anything and is not passed to third-party tools. Ask for the agreement before you send anything you would rather cover first.