EDC - Prelude

Clinical Trial Data Collection

Prelude’s EDC is a web-based software application designed for clinical trial data collection while maintaining regulatory compliance. It replaces the traditional method of recording data on paper with electronic case report forms (eCRFs) designed and built per your study protocol.

Man sitting at laptop consolidating data

Build User-Friendly Workflows

Allow users to access your study from anywhere in the world at any time
Control access to every aspect of your study, including masked and blinded data points
Follow your sites’ progress by tracking study participation and performance

Collect Higher Quality Data

Lower the learning curve – eCRFs look just like paper forms
Collect relevant data as robust edit checks clean data in real-time
Sites have data too! We offer comprehensive data collection and reporting for subjects, sites, users, and the study itself

A female doctor and male nurse inputting data.

Elderly man sitting at laptop sorting data.

Accelerate Study Submissions

Help monitors ensure trial integrity with error and warning indicators, queries, and summaries
Organize eCRFs for quick and easy access – no paper or binders needed
Quickly track and report results back to regulators

30%

Reduction in Average
New User Training

50%

Time Saved
Collecting Data

40%

Time Saved
Performing QA

50%

Fewer Transcription
Errors

75%

Reduction in Average
Database Build Time

Explore Prelude EDC’s core features…

Data Collection

Audit Trail

Complete record of who did what when – eliminating questions and satisfying regulators

Compliance

21 CFR Part 11, Annex 11, ICH GCP, HIPAA, and GDPR Compliant

Electronic Signatures

Strengthen responsibility when every eCRF is signed

Study Conduct

Indicators & Visual Aids

Enable monitors to identify the state of forms and queries quickly so that they can take action as needed

Queries

Enable monitors and site personnel to communicate remotely on a data point of interest

Data Uploads

Upload data contained in delimiter-separator files (e.g., comma-separated value files – .CSV) to save time and avoid transcription errors

Filters & Search

Find the data (e.g., by assigned treatment) you want in just a couple of clicks

Summaries

Review built-in summaries (e.g., enrollment) to get a real-time view of the study’s state

Reports, Graphs & Statistics

Retrieve & share reports and visually review aggregated data across multiple forms for easy comprehension

Study Configuration

Auto-Cleaned Data

Ensure the quality of study data with edit checks to reduce monitor workload

Automation

Get real-time output (e.g., dosage) with automated calculations

Masking & Permissions

Control who can view, edit, sign, and review down to the field level

End of Study

Database Locking

Lock and unlock data at any time, at any level – the form, subject, site, or study

Exports

Archive your data in any format, including XML, HTML, and SAS XPT

Extended Capabilities with Modules

Randomization

Configure randomization – with blocks, strata, and blinding – to conform with any protocol and save statisticians’ time

Medical Coding

Quickly translate adverse events and concomitant medications into predefined codes, terms, and definitions

Invoicing

Get sites paid quickly by setting up a fee schedule based on the study schedule of events

Inventory

Track product availability by recording inventory receipts, dispensing and returns, and reconcile with ease

Document Management

Store study e-binders online – not in filing cabinets – for easy sharing and quick access

Learn more about how Prelude can help you

Build Your Study Without Code

Harness all the capabilities of Prelude and reduce your study build time by 75% with our do-it-yourself tool. No coding experience required.

Female doctor building study with drag and drop feature.

Cut build time in half with an easy drag & drop interface for any data entry field type
Reduce errors and add automation with edit checks & calculations on or across forms
Eliminate bias and improve site experience when entering data with skip logic
Utilize pre-built forms & summaries available for every study
Build forms at the subject and site levels because we know sites have data too
Building multiple studies? Stay with Prelude and reuse your previously built forms stored in your Form Library
Make sure forms are seen by the correct eyes only by defining roles and configuring permissions
Streamline User Acceptance Testing (UAT) with our built-in feedback tool – and leave unmanageable spreadsheets and long email threads behind

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