Datacapt EDC eCRF Clinical Trial Software

Electronic Data Capture for Modern Clinical Studies

Datacapt EDC eCRF makes it easy to build studies, collect, validate, and manage clinical trial data from any source. Designed for all types of protocols, build studies in days, ensure cleaner data, and save significant time and effort.

Electronic Case Report Form
Data Collection
Intuitive and Flexible
Secure and Compliant
Trusted worldwide
Our user-friendly platform is trusted worldwide for clinical study data management

Tired of Clinical Data Management Headaches?
Discover What a Modern EDC/eCRF Can Do.

Modern clinical trials demand more than legacy tools patched for the future.
Datacapt EDC eCRF is a cloud-native, intuitive, and AI-assisted solution designed from day one to empower data-driven research.
From first visit to last patient out, your teams move faster, with fewer clicks, cleaner data and no tech headaches.
Study Design

Build without limits

Datacapt empowers every team with a visual builder, enabling them to design and launch studies quickly, without requiring technical expertise.

Build and deploy studies faster

Preview and test in real-time with zero code

Create complex forms with +25 question types

Advanced field logic for conditional visibility and validation rules (edit checks)

Everything you need to design, and more (visual builder, real-time preview, form library, CDISC compliance, API)

Collect Clinical Data

Stay Ahead with Study Insights

Simplify data entry with the most intuitive eCRF interface. Experience the power of our user-friendly interface, revolutionizing your data collection process like never before.

Sites enter data quickly with smart autofill and skip logic

Any Role, One Interface

Integrate with all sources (EHR, ePRO/eCOA, Wearables and much more) by leveraging the role of APIs in clinical data capture.

Export standardized data anytime in various formats, including CSV, XLSX, PDF, and SAS.

EDC data insights in Datacapt
Monitoring & Real-Time Overview

Get cleaner data with less effort

Gain a comprehensive view of your study’s progress with real-time monitoring tools. Monitoring is a critical mission in clinical trials, ensuring data quality, regulatory compliance, and successful study execution.

Get an overview of Data Entry Progress and Study Statistics

Track and resolve queries efficiently with integrated workflows

Access +15 Comprehensive Reports

Review, Source Data Verification (SDV), Lock, and Sign your Clinical Data with Ease.

Clean clinical data in Datacapt EDC

Experience how Datacapt redefines clinical data collection.

Datacapt isn’t a legacy system, it’s the next generation.

Everything you need and more

Packed with powerful features, 100% cloud and secure.

Mid-study changes

no downtime
Push protocol amendments, form updates or logic revisions during the study. No redeployment, no data loss.
Version 1.0
closed
Version 2.0
live
142 forms carried over
Amend the protocol, keep the data.

Independent study management

From form building to data export, your team configures, runs and updates studies without waiting on a vendor.
Build the eCRF
your team
Run the study
your team
Export the data
your team
No change request, no queue.

Role-based access

per field
Define who can view, edit or lock data, down to the field, with roles you set yourself.
Investigator
view · edit
Monitor
view · query
Data manager
lock
Each user sees only their part of the study.

85 languages

85
Run global studies so your sites and your patients work in their own language.
English
Français
Español
Deutsch
Italiano
Português
日本語
+78 more
One study, every site in its own language.

Easy to learn, fast to deploy

days
Get up and running in days, not weeks, from the first login to the first patient in.
Study build
4 days
First patient in during week one
A short setup, not a training project.

CDISC industry standard

ODM
Our eCRF is built natively on the CDISC ODM format, so your data stays interoperable from day one.
study_2026.odm.xml
SDTM ready
native
Your data. Your rules.

Audit trail and e-signatures

21 CFR 11
Datacapt stamps every entry, change and signature with a user, a date and a reason.
Weight · 72 kg
entry
Corrected · typo
change
Signed by the PI
e-signature
Export the full trail whenever an inspector asks.

Query management built in

2 open
Raise, answer and close queries inside the form, on one thread instead of an email chain.
Monitor: please confirm
open
Site: corrected to 38.2
closed
Average close time, 1.4 days
Your monitors and your sites work from one thread.

Data export on demand

Pull clean datasets when you need them, without filing a request or waiting on a data manager.
CSV
Excel
PDF
CDISC ODM
SDTM
Last export
today, 09:14
No request, no queue.

Randomization built in

stratified
Assign subjects from the screen your sites already use, with no second system to reconcile.
Arm A
24
Arm B
23
Stratified by site and age group
One system, one subject list.

Medical coding in place

MedDRA
Code adverse events and medications inside the study database, without exporting a line.
Verbatim · bad headache
10019211 · Headache
WHODrug for medications
Coders and monitors share one database.

eConsent in the same study

signed
Patients sign on site or at home, and the signed form lands in their subject record.
Consent v2.0
sent
Signed 12 Mar, 10:41
in record
Version tracked per patient
No paper to chase.

Live edit checks

1 error
Ranges, cross-form rules and mandatory fields fire while site staff type.
Systolic BP · 128
Temperature · 48.2
Out of range: 35.0 to 42.0
The site fixes it before it leaves the screen.

Reports your monitors ask for

Query, SDV, review and visit reports, filtered per site and exported in two clicks.
Query
SDV
Review
Visit
Inclusion list
Filter by site
12 sites
Ready before the visit, not after it.

Open REST API

REST
Push and pull subjects, items and files from your own systems with an API key.
POST /v1/subjects
Response
200 OK
api.datacapt.com
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Frequently asked questions

Everything you need to know about Datacapt EDC and eCRF.

What is Datacapt EDC?

Datacapt EDC is an electronic data capture application that allows CROs, Sponsors and Academic Research to design and build data collection forms and enables patient data collection from sites efficiently and securely.

Do I need technical skills to build or manage an eCRF?

Designing eCRFs is intuitive and guided through a visual builder. No technical skills are needed, and you can use pre-built templates or customize forms effortlessly to suit your study.

Is Datacapt 21 CFR Part 11 compliant?

Yes. Datacapt is fully compliant with 21 CFR Part 11 and other data privacy regulations. The platform is validated, traceable, and audit-ready at all times. Validation documentation is available on request.

Are audit trails and electronic signatures part of the system?

Yes. Every data entry, change, and user action is audit-trailed in real time. Electronic signatures are Part 11-compliant, timestamped, and fully traceable—meeting all regulatory expectations.

How secure is the data in your EDC/eCRF system?

Your data is protected using end-to-end encryption—both at rest and in transit. We use AES-256 encryption, secure HTTPS protocols, and enforce strict data access policies across the platform. Data is hosted on ISO 27001-certified cloud infrastructure with geographic redundancy.

How does role-based access work in your eCRF?

You can assign roles and permissions at a granular level, from data entry and monitoring to database lock and export. Each user only sees the data and features they need, ensuring security and clarity.

What export formats are supported?

We support exports in CSV, Excel, PDF, and SDTM formats. You can export data on-demand at any point. Exports are secure, audit-logged.

How long does it take to launch a study with Datacapt?

Most studies can be built and deployed in less than one week using our form builder and template libraries.

What do customers say about Datacapt ?

Find out why 200+ companies place their trust in the Datacapt Platform to manage their clinical trials.

CRO
Thanks to Datacapt, we cut our site training time by four, reduced setup timelines by 40%, and boosted both our processes and responsiveness.
Chloé Arnous
Clinical Project Manager
Patient research
I was able to configure, test, and launch the survey in just four days, making real-time adjustments and validating the solution without relying on technical intermediaries.
Eva Menard
Founder
Biotech
Datacapt surpassed our expectations thanks to its user-friendly interface and the availability of its team. It made form design and data collection remarkably intuitive, resulting in significant time savings and enhanced accuracy.
Axel Boulet
Data Steward
Medical devices
By trusting Datacapt, we quickly achieved a level of regulatory compliance we couldn’t have reached on our own, while gaining autonomy in our clinical studies.
Samuel Lerman
Co-founder
CRO
When I first opened Datacapt, I instantly got the feeling this was the next generation of eClinical platform.
Jakub Poplawski
Global Dir. Business
Academic research
Datacapt is a reliable and educational tool, designed to support researchers at every stage of their clinical study.
Prof. Laurent Clavel
Head of the Palliative Care Dpt
CRO
Beyond the tool, we found a reliable partner capable of evolving with us and understanding our specific needs.
Véronique Saunier
Clinical Investigations Coordinator
Digital health
The Datacapt solution allows you to optimize your studies management, with quality and safety assurance.
Louis Létinier
Co-founder
CRO
Thanks to Datacapt, we cut our site training time by four, reduced setup timelines by 40%, and boosted both our processes and responsiveness.
Chloé Arnous
Clinical Project Manager
Patient research
I was able to configure, test, and launch the survey in just four days, making real-time adjustments and validating the solution without relying on technical intermediaries.
Eva Menard
Founder
Biotech
Datacapt surpassed our expectations thanks to its user-friendly interface and the availability of its team. It made form design and data collection remarkably intuitive, resulting in significant time savings and enhanced accuracy.
Axel Boulet
Data Steward
Medical devices
By trusting Datacapt, we quickly achieved a level of regulatory compliance we couldn’t have reached on our own, while gaining autonomy in our clinical studies.
Samuel Lerman
Co-founder
CRO
When I first opened Datacapt, I instantly got the feeling this was the next generation of eClinical platform.
Jakub Poplawski
Global Dir. Business
Academic research
Datacapt is a reliable and educational tool, designed to support researchers at every stage of their clinical study.
Prof. Laurent Clavel
Head of the Palliative Care Dpt
CRO
Beyond the tool, we found a reliable partner capable of evolving with us and understanding our specific needs.
Véronique Saunier
Clinical Investigations Coordinator
Digital health
The Datacapt solution allows you to optimize your studies management, with quality and safety assurance.
Louis Létinier
Co-founder
How working with us starts
Three steps from this page to a study open for inclusion.
1
Book the discovery call
Thirty minutes with a clinical data specialist, your protocol on screen.
2
Take the product tour
One hour in the platform. We run your study through the modules you would use.
3
Go live
We set up your team, then your study opens for inclusion.

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News, Articles, Resources et Tutorials.

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