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.
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Complete record of who did what when on every form – eliminating questions and satisfying regulators
21 CFR Part 11, Annex 11, ICH GCP, HIPAA, and GDPR Compliant
Strengthen responsibility when every eCRF is signed
Enable monitors to identify the state of forms and queries quickly so that they can take action as needed
Enable monitors and site personnel to communicate remotely on a data point of interest
Upload data contained in delimiter-separator files (e.g., comma-separated value files – .CSV) to save time and avoid transcription errors
Find the data (e.g., by assigned treatment) you want in just a couple of clicks
Review built-in summaries (e.g., enrollment) to get a real-time view of the study’s state
Retrieve & share reports and visually review aggregated data across multiple forms for easy comprehension
Ensure the quality of study data with edit checks to reduce monitor workload
Get real-time output (e.g., dosage) with automated calculations
Control who can view, edit, sign, and review down to the field level
Lock and unlock data at any time, at any level – the form, subject, site, or study
Archive your data in any format, including XML, HTML, and SAS XPT, and extract files uploaded throughout the duration of the study
Configure randomization – with blocks, strata, and blinding – to conform with any protocol and save statisticians’ time
Quickly translate adverse events and concomitant medications into predefined codes, terms, and definitions
Obtain electronic informed consent from study participants
Get sites paid quickly by setting up a fee schedule based on the study schedule of events
Track product availability by recording inventory receipts, dispensing and returns, and reconcile with ease
Store study e-binders online – not in filing cabinets – for easy sharing and quick access
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Harness all the capabilities of Prelude and reduce your study build time by 75% with our do-it-yourself tool. No coding experience required.
