01
Sponsors with in-house data management
A CDMS that matches their SOPs and standard forms library.
Healthcare / Clinical Trials CDMS
Clinical data management systems built to reach a clean lock
Studies slip at the end when queries pile up, lab data will not reconcile and the SDTM mapping starts too late. Agnotic Technologies builds CDMS and EDC software that designs the eCRF, the edit checks and the exports together, so the database can be locked on plan.
CDASH to SDTM
Mapping planned with the eCRF
Checks at entry
Edit checks fire before a query is needed
Lock-ready
Review, coding and reconciliation tracked
Trusted by global innovators
Industry Overview
What is a clinical data management system?
A clinical data management system (CDMS) is the software a sponsor or CRO uses to collect, clean and lock trial data: electronic case report forms (EDC), edit checks and queries, medical coding, external data loads and CDISC exports. Agnotic Technologies builds clinical trials CDMS platforms and EDC modules around your protocol and data management plan.
Industry Challenges
Why do studies slip at database lock?
Lock is where every earlier shortcut in data management comes due.
Checks added late: edit checks written after go-live, so months of data are queried in one batch.
Query ping-pong: queries worded vaguely, answered vaguely and reopened, with no aging report anyone acts on.
Spreadsheet reconciliation: central lab, eCOA and IRT data matched to the eCRF by hand at the end of the study.
Mapping left to the end: eCRF fields that do not map cleanly to SDTM, found when the datasets are built.
Coding outside the system: adverse events and medications coded in a separate file, with no audit trail of who coded what.
Our Approach
How should an eCRF be designed?
Most cleaning effort is decided when the forms are built. These are the design rules we apply.
Start from CDASH
Fields follow CDASH where a standard exists, so collection lines up with SDTM from the first form.
Forms follow the schedule
Forms and visits come from the protocol's schedule of assessments, with conditional fields instead of free text.
Mapping beside the field
Each field carries its intended SDTM domain and variable, reviewed with your programmers before go-live.
Checks with the form
Edit checks are specified and tested with each form, not added once data starts arriving.
Capabilities
What does a CDMS include?
Modules we build for a CDMS or EDC, alone or added to the systems you already run.
eCRF design and study build
Forms, visits and conditional logic built from the protocol, versioned for amendments.
Edit checks and query management
Checks at entry and in batch, queries with owners, due dates and aging.
Medical coding workflow
Verbatim terms coded against MedDRA and WHODrug dictionaries licensed by you, with coder review and audit.
External data loads
Central lab, eCOA and IRT data loaded on schedule and reconciled against the eCRF.
Review and freeze status
Source data verification, data manager review, investigator sign-off and form freezing tracked per form.
Lock and CDISC exports
Database lock under a controlled process, with SDTM datasets and ODM archives produced from the locked data.
Engineering Stack
Standards and technologies behind a CDMS
The data standards, dictionaries and platforms behind the CDMS and EDC software we build.
CDISC standards
CDASHSDTMODMDefine-XML
Coding dictionaries
MedDRAWHODrugLicensed and versioned by the sponsor
Data feeds
Central lab transferseCOA and IRT feedsHL7 FHIR R4 from site EHRs where agreed
Backend and infra
PythonNode.jsPostgreSQLAWSAzure
Edit checks
Which edit checks catch which errors?
The check types we specify with your data managers. The aim is to catch an error while the site still has the source in front of them.
| Check type | Example | When it runs | Who resolves it |
|---|---|---|---|
| Required field | Visit date left blank on a completed form | On save | Site staff |
| Range | A vital sign outside the range in the data management plan | On save | Site staff, confirming or correcting |
| Cross-form consistency | An adverse event start date before the consent date | On save or nightly | Site staff, after the data manager's query |
| Visit window | A visit date outside the protocol's window | On save | Site staff, or recorded as a deviation |
| External reconciliation | A lab sample date with no matching visit in the eCRF | After each data load | Data manager with the lab or site |
| Coding | A verbatim term too vague to code | During coding | Coder query to the site |
Measured Impact
What does a data management dashboard show?
Measures we build reporting around, agreed with your data management lead before go-live.
Query aging
Open queries by age
By site and form, so old queries are chased first.
Entry lag
Visit date to data entry
Shows sites falling behind on entry.
Review status
Forms awaiting review or sign-off
Verification, data manager review and investigator signature.
Reconciliation
External records unmatched
Lab, eCOA and IRT records with no eCRF match.
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A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.
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A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.
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Use Cases
Who builds a CDMS with us?
Teams that need data management software shaped to their own studies.
02
CROs
Multi-sponsor EDC with study builds reused across clients.
03
Device and diagnostics sponsors
eCRFs for device studies, with performance data from instruments.
04
Academic coordinating centres
Investigator-initiated studies across several hospitals.
05
Registries
Long-running observational data collection with periodic exports.
06
CDMS for startups
Clinical trials CDMS for startups building a data management product or service.
Integrations
Systems a CDMS exchanges data with
The systems that send data into the CDMS or take data out of it.
Participant data
eCOA and ePRO
Randomization and dispensing
IRT
Lab data
Central laboratories
Reads
Imaging core labs
Serious adverse events
Safety database
Analysis
Statistical computing environment
Self-assessment
Is the database ready to lock?
The lock readiness checklist we build into the data manager's dashboard, so each item shows as done or open at any time. Your SOPs decide the final list.
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
General Data Protection Regulation
Implement lawful consent flows, data minimization, and secure processing for global data privacy.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How do we build a CDMS?
How to build clinical trials CDMS software around one study first. Timing depends on scope, and we agree a fixed first release on the scoping call.
01
Scoping call
We agree the study, the forms library, the external data and the exports you need.
02
Data management plan walkthrough
We go through your data management plan and edit check specification with your data managers.
03
Fixed-scope first release
eCRFs, edit checks and queries for one study, with audit trail and role-based access.
04
Add coding, loads and exports
Medical coding, external data loads and CDISC exports added and tested against real study data.
05
Validation and support
Specifications and test evidence for your validation team, then support through lock under agreed terms.
Facts and sources
Which rules and standards shape a CDMS?
Short facts behind clinical data management software, each linked to its primary source.
Under 21 CFR 312.62(b), an investigator must prepare and maintain adequate and accurate case histories for each individual in the investigation, and case histories include the case report forms and supporting data.
Source: 21 CFR 312.62(b) (eCFR)CDISC describes CDASH as a standard way to collect data consistently across studies and sponsors, so that data collection formats give clear traceability of submission data into SDTM.
Source: CDISC, CDASHCDISC states that SDTM is one of the required standards for data submission to FDA in the United States and PMDA in Japan, with FDA's requirements set out in its Data Standards Catalog.
Source: CDISC, SDTMCDISC describes ODM as a vendor-neutral, platform-independent format for exchanging and archiving clinical research data with their metadata and audit information, widely used to represent case report form content in EDC tools.
Source: CDISC, ODMICH E6(R3) says that before data are provided for final analysis and, where applicable, before the trial is unblinded, edit access to the data acquisition tools should be restricted.
Source: ICH E6(R3), section 3.16.1(r) (ICH)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related services
Related clinical trial and data services
Pages for the systems that feed a CDMS or use its data.
Life sciences and clinical trial software development
The wider view of study software: recruitment, eConsent, participant apps and Part 11 controls.
Clinical trial management software (CTMS)
The operational layer: sites, subjects, visit schedules, enrollment and monitoring.
Laboratory information system development
Lab systems that produce the results a CDMS loads and reconciles.
FHIR integration
EHR data read over HL7 FHIR R4, for studies that pull values from site records.
HIPAA requirements for software teams
The safeguards we build into every system that holds patient data.
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Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
EDC is the part sites use to enter data into electronic case report forms. A CDMS is the wider system data managers use to clean and lock that data: queries, coding, external data loads, review status and exports. We build either, or both together.
No. Those dictionaries are licensed from their owners by the sponsor or CRO. We build the coding workflow so it loads the dictionary versions you license and records which version coded each term.
It can produce them from the locked data when the eCRF was designed with SDTM mapping in mind. We record the target domain and variable beside each field, and your programmers review the mapping and the Define-XML before submission.
Yes. We load central lab, eCOA and IRT data on agreed schedules, and exchange study data with other EDC systems through CDISC ODM or agreed transfer specifications.
With HIPAA-ready engineering: coded participant identifiers, encryption, role-based access and full audit trails. Agnotic signs a business associate agreement or data processing agreement where the data requires it, and can work inside your cloud account.
The number of forms and edit checks, the external data feeds, coding, the export standards you need, migration of studies already in progress, and the validation evidence your quality team asks for. We describe these drivers on the scoping call rather than quote a price before it.
Yes. A common first release is the eCRF, edit checks and query workflow for one study, with coding and exports added next. It depends on scope, and we agree the first release on the scoping call.
AI tools help our engineers draft code and tests. An engineer reviews every change, and every release is tested against the requirements and test scripts your validation team signs off.
Industries