Electronic Data Capture (EDC)

An Electronic Data Capture (EDC), also known as Direct Data Capture (DDC), is a system designed to allow collection of clinical data through computerized system. It helps accelerate and streamline data collection methodology by replacing the traditional paper based CRF with an organized and standardized process.

Clinical Data is the mirror of the clinical trial activity from which it will help to describe the how the activity was done. Now a day data should be capture by the Electronically called as the (EDC) Electronic data capture means the collection of the clinical data by the computerised system.

EDC/DDC allows accurate, clean and fast access to collected clinical data. It also collects data through electronic interfaces and captures the same into the eCRF.

BizNET provides an EDC/DDC solution to get the error free data from the beginning of the clinical trial to report submission of the project in which all the activity of the trial should be recorded in the one roof like Registration of the Volunteer/Patient, Screening, check in, Randomization, Dispensing, Dosing, Blood Collection as per the schedule time Vitals, Adverse Event Recording, SAE Recording, checkout, Edit Check, QC review, Discrepancies Management QA Review, Edit Checks Creation and Execution, Report Preparation in CDSIC, SDTM or As Per Requirement of the Regulatory Authorities all the EDC done in BizNET.

BizNET provides an EDC/DDC solution especially designed to support BA-BE projects where the data collection is required timely (fixed time points and intervals as decided for the project) and periodically – using user-friendly data entry and review. In turn, would save in time and paper costs.

BizNET also allows data collection for IP administration (dosing) and Sample collection activities through barcode.

Features:

Capture Accurate, Legible, error free and complete data into eCRF according to protocol

Electronically capture data into eCRF

Allow to design eCRF as per the EDC requirement to capture the key data from the protocol and source document

Multi-Site user Access easily

Reduce error, Improved data quality with speed up and reduce the cost of the research

Generate barcode for IP dosing and Sample collection to avoid the sample mix-up

Project-wise subject management

Randomization or Treatment assignment

Real time data capture

Visit-wise scheduling

Capture/Identify data using barcode gun reader

Online review process

Custom defined alerts during data entry for clean data capture and helping to avoid the surprises at the end of the study

Meet all the criteria of Regulatory guideline and compliance of 21 CFR part 11 and ICH -GCP

Regulatory compliant, multi-functional Clinical trials management software solution for CROs

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