niAnalytics EDC/CTMS

niAnalytics EDC/CTMS

The niAnalytics EDC/CTMS is a unique integrated SaaS solution that, due to its built-in flexibility, is designed for all clinical trial types and organizations regardless of their size.

The niAnalytics EDC/CTMS integrates EDC, double data entry, eTMF, WebPRO, Source Data Verification, integrated advanced Query Module and metrics, automatic trigger and query generation as well as assignment, automatic AE reporting and categorization and much more. The niAnalytics EDC/CTMS has been built for the ground up with the latest clinical data standards in mind including CDISC and Good Clinical Data Management Practice.

The niAnalytics EDC/CTMS is accessible from any browser, supports any language including right-to-left languages. It is built to support multiple trials in a single instance of the system, meaning that all your studies and associated documents will be on a single system with one simple log-in. A user can have different roles with different permissions and have access to system modules, documents and reports across multiple trials simultaneously, all with one log-in.

Key features:

Every device, every browser
Multiple simultaneous trials on a single system
Simultaneous multiple language support (user level adjustability)
eTMF for simultaneous multiple studies
Unlimited EDC form creation
Custom granular user security and permission control
WebPRO
Per variable for
Detailed usage metrics and comparison by:
User
Site
Organization
Document
Query
Time on system
Number of log-ins

niAnalytics System Features Overview

eCRF – Turnkey Solutions

eCRFs are the core EDC functionality of any clinical trial data management system. The niAnalytics system has been built on CDISC standards with SDTM tabulations, making end-of-trial data analytics compatible with all applicable regulations.

We know that you are busy performing your core business activities, those activities that you are best at. Therefore, why would you have to be bothered with being trained to create eCRFs in a foreign system? We take eCRF creation out of your hands and offer a turnkey solution. Our data management experts work with you personally to create your eCRF, validate it, and stand behind our work with our industry leading support.

eCRF

Key features:

User specific multi-language support
Granular custom user permission settings
Multiple simultaneous trial-specific user permission settings
Rapid eCRF creation
In-trial eCRF changes (minutes to hours)
Insertion of running record chapters for AEs, SAEs, CMs
Automatic eCRF Form export (single page or entire form)
Rule and formula editor
Custom calculate fields
Automatic triggers, query generation and assignment
Automatic (S)AE reporting and categorization
Documentation of concomitant medications
Double data entry (DDE)
Upload of any type of data file
Notes, comments, queries on any document field (with history)
Detailed granular access control for each document type
Full audit trail and history of changes
SDTM Tabulation

The entire niAnalytics EDC/CTMS system has been constructed so that any and all EDC forms created have the same functionalities as eCRFs by default.

niAnalytics Clinical Trial Management and eTMF

The niAnalytics EDC/CTMS enables complete collaborative study management by having the electronic Trial Master File as well as administrative forms such as visit reports and study logs in a single cloud based system. The niAnalytics team can create any type of EDC form including visit report forms, logs, or any other form that your trial may require. The flexibility of the niAnalytics EDC/CTMS means that you do not use predefined forms, rather our expert staff works with you to create exactly the tools that you need for your organization-specific workflows. Data in any form created in the niAnalytics system is handled in the same manner as eCRFs, thus providing the same level of security, accountability, data review, communication and analysis as an actual eCRF.

Clinical Trial

Key features:

User, site, organization, and trial administration
Granular document, site, and trial-specific user permissions
Staff management
Reports - site initiation, visit, close-out, audit
Logs - temperature, transport, etc.
Upload of any read-only document
.pdf, .doc, .xls, etc.
Contracts, letters, regulatory filings, insurance

The ability to upload and control the access permissions for any read-only document, enables the niAnalytics EDC/CTMS to be the place for all your clinical study data, from eCRFs, to reports, to the entire eTMF. Why use and learn multiple systems when with the niAnalytics EDC/CTMS your team has the access to all the documents they will ever need in one convenient location.

SDTM Tabulation

The niAnalytics EDC/CTMS is built with SDTM tabulation at its heart, allowing for each variable and field to be individually designated for SDTM tabulation upon creation of any EDC form. Thus, enabling us to create CDISC-SDTM-compliant datasets which are ready for reporting, analysis and submission directly inside of our database. Mapping instructions include rules for data derivations and data conversions.

SDTM Tabulation

Key features:

Per variable SDTM mapping
Creation of define.xml
Mapping of EDC datasets and SDTM datasets
Setup of SUPPQUAL domains
Creation and export of SDTM-annotated eCRFs
Our data team and statisticians review and if necessary clean any data (if required)
Ready to export into any statistical software

niAnalytics Double Data Entry

In the niAnalytics EDC/CTMS system any EDC document can be designated for double data entry, not only eCRFs. Upon the creation of a document instance (or patient in the case of an eCRF) the system automatically creates two independent versions of the document. EDC documents are filled out as any standard EDC document with all automatic data checks, triggers, queries etc. Upon the completion of data entry into both versions of the document, the user enters the Data Comparison module where the double data check is performed. In one form only data discrepancies are presented, and the user is prompted to choose from only the data discrepant data in either of the tow entered forms. Once the data is selected, the system combines the two forms into one finalized dataset and enters it into the database. The two previous forms are still available for review.

niAnalytics Double Data Entry

Key features:

Double data entry for any EDC document type, not only eCRF
Blind double data entry into two independent, but connected forms
Automatic discrepancy detection
Presentation only of discrepant data during the data comparison process
Full audit trail and data export of one, both or merged document data

WebPRO

Patient Reported Outcomes (PRO) are increasingly important for all types of studies. Whether they are questionnaires, patient diaries, or data from wearable devices, the niAnalytics system can handle it all. For the niAnalytics EDC/CTMS, WebPRO is not a special system module rather a natural inherent extension of the EDC system. As such, it runs on any web browser, on any device and in any language. All that is required is an internet connection, and no special software. Our system can be adapted to integrate data from most any wearable device.

WebPRO

Key features:

Use on any device including computer, tablet, or smartphone
Simple user interface
Subject account management
Reminders and notification emails
Reports
Role-based permissions for the visibility of patient data
Simple question
Integration of data from wearables

Query Manager

The niAnalytics EDC/CTMS has a dedicated Query Manager Module which gives a detailed overview of all queries that a user has the right and permissions to either view, ask, respond to or close. The Query Manager lists all queries and their details including query type, trial, investigational center, instance (patient) ID, query location and creator as well as the date of the last change and full query history. Clicking on the query location directly opens the exact eCRF and document field (query location). Additionally, the niAnalytics system automatically tracks time to answer, resolve and close a query.

Query Manager

Key features:

Automatic query generation based on predefined field rules and triggers
Automatic query addressing
Full query history
Addition of notes to a query
The ability to comment on a query and address the comment to a user
Conversational comment thread
Detailed query management
Query metrics