Smart R; IWRS (Interactive Web Responsive System)

One of the most important design techniques for avoiding bias in clinical trials are blinding and randomization.

Randomization is a key element in the success of a trial. An effective randomization plan built into an Interactive Response Technology (IRT) system forms the basis of an adequate and well-controlled trial that is free of bias, maintains the study blind and ensures that the desired balance and treatment allocation ratios are preserved throughout the trial.

Modern systems and simulation techniques are in place that have also greatly reduced the timelines to implement an IRT system while also providing high quality, reusable algorithms with a greatly reduced validation effort.

Sarjen’s Smart R is customized to provide the exact level of IWRS functionality required for studies including real-time Subject status/visit tracking, Drug supply/shipment management to the different sites of operation, randomization, email notification, edit checks and is capable to generate various combination of reports.

Smart R, IWRS customized service

Study Set-up/Site Set-up

Map Subject Schedules & Activities

Blinded Kit Creation

Kit QA Release

Manual Re-Supply/ Automatic Re-Supply to trial Sites

Shipment Receipts

Randomization of Subjects based on Stratification Factors

Stock Level Reports

Dispensing

Features:

Role and Rights driven with audit trails (part 11 compliant for electronic records and electronic signatures)

Setup – Study

Investigational Product (Study Drug) like Storage, Storage Location, storage area, Product Type, Reason, Transporter

About the different stages of product Verification

Receipt, Quality movement, Site Resupply, Dispatch, Shipment Confirmation

Barcoded to avoid bias

For IMP (Investigational Medicinal Product) and Non-Imp (Non -Investigational Investigational Medicinal Product) Mapping

MIS Reports and Tracking

Stock report, Accountability Report, Retention Report, Unblinded Depot Stock Details, Kit Report, Logistic Report, Stock Report, etc.

Status and Notifications

Email and tracking of every activity

Complete Solution for Screening activities, patient details information, visit schedular, Patient status change and End of Study.

Sarjen can help in synchronizing the study/s – right from setup, programming, validation, and Installation at the site of operation.

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

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