BEYOND ELECTRONIC DATA CAPTURE

niAnalytics EDC/CTMS - niServices

The niAnalytics ecosystem is comprised of two parts, our custom niAnalytics EDC/CTMS and our niServices. Collectively they enable us to provide our customers with a full data management solution that is truly Beyond Electronic Data Capture. We enable our customers to focus on what they do best: efficiently, effectively, and successfully run their clinical trials.

electronic data capture – clinical trial management system – clinical data management – statistical services

assistance
with trial set-up

advanced
eCRF

almost unlimited
EDC capabilities

electronic
Trial Master File

collaborative document
management tools

back-end
statistical services

niAnalytics GmbH offers a unique and comprehensive set of software and services solutions for pharmaceutical and medical device companies, sponsors, contract research organizations, as well as academic institutions and hospitals.

Our data management approach supports all types of clinical trials and post-marketing studies. Whether you are a pharmaceutical or medical device company, academic or clinical institution, the niAnalyitcs ecosystem will help you succeed.

The niAnalytics EDC/CTMS system was created to facilitate minimum lead time for eCRF and database creation and validation. At niAnalytics we can create your eCRF and database in a matter of days, not weeks or months, resulting in dramatic savings. We can perform your in-trial changes in a manner of minutes to hours instead of days or weeks.

niAnalytics EDC/CTMS

Our niAnalytics EDC/CTMS system modules include:

Document Management

Document
Management

Data Capture

Data Capture
(eCRF, forms, eTMF,
reports, WebPRO)

Double Data Entry

Double
Data Entry

Centralized Query Manager

Centralized
Query Manager

Patient Dashboard

Patient
Dashboard

Patient Calendar

Patient
Calendar

Study Metrics

Study
Metrics

The niAnalytics EDC/CTMS is a robust system which provides intuitive easy to use resources and facilitates the performance of any clinical trial no matter how small or large.

We make the entire process easy, smooth and cost effective. The niAnalytics EDC/CTMS is simple to use, flexible and can be fully customized to the customer's business processes. Any type of EDC document can be created, not only eCRFs. Your imagination is our limit!

Every device, every browser
Multiple trials on a single system
Simultaneous multiple language support (user level adjustability)
eTMF for simultaneous multiple studies
Rapid eCRF creation and in-trial eCRF changes (minutes to hours)
Automatic eCRF export (single page or entire eCRF)
Unlimited data capture forms including cloud-based visit reporting
Double Data Entry
Remote monitoring
Automatic (S)AE reporting and categorization
Automatic query generation and assignment
Query metrics
WebPRO
Granular control of SDTM tabulation
Custom granular user security and permission control
Detailed user activity metrics
Full audit trails and histories, including queries

Do you need such a system?

Please contact us and we will be happy to serve you!

CDISC

GAMP 5

GCDMP

21 CRF Part 11

HIPAA

niAnalytics EDC/CTMS adds value and help our customers save money

Flow Chart

PARTNERS

Appletree CI Group

Charite

InselSpital