Todo lo que su estudio necesita, en un solo EDC.
Recorra las 41 funcionalidades de abajo y marque lo que su protocolo exige, desde el primer campo que coloca en un formulario hasta la exportación SAS al cierre de la base.
01
Build the eCRF
Design the forms, the visits and the rules, then start entering the same week.
Form builder
drag
Drag fields onto the page, set the visits and forms, and the eCRF takes shape as you build it.
Text
Date
Scale
Subject ID
Visit date
Drop a field here
Visual builder
Question types
30
Dates, scales, units, coded lists, file uploads: 30 field types to pick from.
Text
Number
Date
Time
Scale
Radio
Checkbox
Dropdown
File
Signature
+15 more
Every field type your protocol asks for.
Visibility conditions
A field appears when an earlier answer calls for it, and stays hidden the rest of the time.
IF adverse_event = "Yes"
AE start date
3 fields stay hidden
Sites see only what applies to them.
Edit checks
1 error
Set ranges and consistency rules, and the form flags an out-of-range value as the site types it.
Systolic BP · 128
Temperature · 48.2
Out of range: 35.0 to 42.0
The site fixes it before it leaves the screen.
Formulas
Derive BMI, scores and intervals from fields the site already filled in.
weight / ((height / 100) ^ 2)
BMI
24.6
auto
Write the expression, read the result.
Mid-study change
Add a field or change a rule during the study; earlier entries keep their version.
Version 1.0
closed
Version 2.0
live
142 forms carried over
Amend the protocol, keep the data.
Real-time preview
live
Move a field on the builder side and the form beside it redraws while you work.
Weight
Height
BMI
Height
172 cm
BMI
24.1
Both sides move together
Role-based visibility
3 levels
Hide an event, a form or a single item from a role, and it stays off their screen.
Level
Site
Monitor
Event
on
on
Form
on
off
Item
off
on
Per event, per form, per item
Edit check actions
3
A failed check raises a query, shows the site a message, or keeps the value out of the export.
If the rule fails
Raise a query
query
Show a message
info
Exclude the value
exclude
You pick the action per rule
Build validation
1 to fix
Run the build check and read what a change would break before it reaches your sites.
Validation
12 checks
Forms and visits
✓
Code lists in use
✓
BMI formula: SEX removed
break
Nothing ships until it passes
Item dictionary
Every variable in one list: name, type, code list, and the forms that use it.
Variable
Type
WEIGHT
Number
SEX
Code list
VISDAT
Date
The reference your data manager works from
Code lists
6 forms
Build a coded list once, reuse it across forms, and change it in one place.
SEX01
Code
Male
1
Female
2
Not reported
3
One list, every form that calls it
Templates
import
Import a study you have run before and start from its forms instead of a blank page.
Start from
Phase II oncology
import
Tolerance study
import
Registry follow-up
import
Your last study, as a starting point
Annotated blank PDF
PDF
Export the empty eCRF with the variable name printed beside each field, ready for your trial master file.
Blank eCRF
Annotation
Weight
WEIGHT
Visit date
VISDAT
Sex
SEX
Every field carries its variable name
Role-based editing
Decide who enters a value, who reviews it, and who only reads it.
Role
Rights
Site nurse
enter
Monitor
read
Data manager
review
Per role, per site
Related module
Medical coding
Map verbatim terms to MedDRA and WHODrug on the same items your sites enter.
02
Collect from your sites
What sites and patients fill in, and what you chase when a form runs late.
Open queries
12
Raise a query on any value, send it to the site, and follow it through to closure.
Site 03
5
Site 07
4
Site 12
3
Oldest: 6 days
Source verification
SDV
Flag the fields that need SDV, and monitors see what is left to check before a visit.
62%
1,204 of 1,943 data points
Data review
Filter to the pages that changed, check them, and mark them reviewed.
Vitals
approved
Labs
approved
AE log
in review
Your data manager signs off page by page.
Missing data report
Pull the forms each site still owes you, by site and by visit, before your next cleaning round.
14
-9 since Monday
Forms awaiting entry
Participant status
Follow each participant across visits on one line, from consent to study exit.
P-0142
randomised
P-0143
screening
P-0144
completed
Screening through to the last visit
ePRO completion
92%
Send questionnaires to patients between visits and track who answered.
Last 7 days
Patients answer on their phone, you read it here.
Languages
85+
Translate the form once and each site reads it in its own language, 85+ supported.
English
en
Français
fr
Español
es
Português
pt
One build serves every site.
Related module
eConsent
Collect investigator and patient signatures, and keep every consent version on the same database.
Data entry
site
The site opens the visit, fills the form and moves to the next one without leaving the page.
Systolic
128 mmHg
Diastolic
82 mmHg
Visit 2 of 6
Real-time saving
saved
The answer reaches the database as the site types it, so a dropped connection costs no work.
Field
State
Systolic 128
✓
Diastolic 82
✓
Heart rate 64
No save button to forget
Live edit checks
1 error
The rule fires while the site is still on the field, not the night after the visit.
Weight 71.4 kg
Height 17 cm
Outside 120 to 210 cm. Check the source.
Caught before the page is left
Signature
Part 11
The investigator signs the casebook with their own credentials, and the signature keeps its meaning and its timestamp.
Casebook 0142
State
Investigator
✓
Meaning: I approve this data
Signed 14:22, 2 Sep
Credentials, meaning, timestamp
Query report
12 open
Every open and closed query with its site, its age and the person it waits on.
Site
Open
Site 01
6
Site 04
4
Site 07
2
Oldest open: 6 days
SDV report
SDV
What each monitor verified, what is left, and the fields still waiting on a source check.
Site
Verified
Site 01
92%
Site 04
61%
Site 07
38%
By site, by visit, by field
Review report
review
Which pages your data manager signed off, which they reopened, and what still waits.
Pages
State
Reviewed
418
Reopened
12
Waiting
64
Page by page, with who signed it off
Visit report
visits
Each participant's visits: done, planned, out of window, missed.
Participant
Visit 3
0142
done
0143
window
0144
missed
Out-of-window visits show as you go
Per-visit reports
6 visits
The same figures cut per visit, so you compare screening against week 12 instead of one total.
Screening
Week 12
Completion, queries and SDV, per visit
Inclusion list
324
Who was included, with their screening number, their site and their inclusion date.
Participant
Included
0142 · Site 01
12 Aug
0143 · Site 01
14 Aug
0144 · Site 04
18 Aug
Export it for your sponsor file
Related module
ePRO
Send questionnaires between visits, chase reminders and track completion.
Related module
Patient database
Screen candidates and check eligibility before you build the inclusion list.
Related module
Calendar and scheduling
Set the visit windows and patient reminders your visit report reads.
See it on your own protocol
Thirty minutes: we go through what you need to collect, then show the parts of Datacapt that cover it.
03
Watch the study run
Enrolment, data quality and site behaviour, on figures that move as data arrives.
Enrolment
Watch recruitment against target across your sites, without building a report.
81%
324 of 400 patients
Monitoring
Compare queries, missing data and entry delay to pick where to visit next.
S01
S07
S12
Risk signals, site by site
Site progress
Read completion site by site and spot the ones that fall behind.
Site 01
92%
Site 05
78%
Site 09
45%
Forms completed per site
Live progress
now
Figures move as sites enter data, so your weekly meeting runs on today's numbers.
1,842
forms submitted today
+37 in the last hour
No overnight refresh
Related module
Randomization
Assign participants to an arm and hold the blind.
04
Close and deliver
Lock the database, account for every change, and hand your statistician a clean export.
Lock
Freeze the data once it is final: entry stops, and the audit trail keeps who locked it.
Form lock
Visit lock
Database lock
Lock a page, a visit, or the study.
Permissions
Give each user entry, review, monitoring or read-only rights on the sites they work on.
Investigator
Monitor
Data manager
Role by role, site by site
Audit trail
Part 11
Each change keeps its user, timestamp and reason, ready for an inspector.
14:02 · Weight 72 → 74 · MD
13:48 · Query opened · CRA
11:20 · Page approved · DM
Who changed a value, when, and why
Export
Download the dataset as CSV, XLSX, PDF or SAS when your statistician asks.
CSV
raw data
XLSX
listings
PDF
casebooks
SAS
analysis
Four formats, one click
CDASH
native
Items carry their CDASH name from the build, and your team exports the study as CDISC ODM.
CDASH
item names
ODM 1.3.2
study design
ODM XML
data export
No mapping pass before delivery.
Related module
API
Move studies, participants, forms and exports on a schedule instead of by hand.
Compliance
Security and privacy
Hosting, certifications, data residency and the validation package an inspector asks for.
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.
Explore the rest of the platform
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