Our systems keep YOU AHEAD

For us the software is only a tool.
We focus on delivering solutions to our clients' needs.

Czech technology company, privately owned, based in Prague

Specializing in pharmaceutical industry

Products for pharmaceutical companies and CRO's

15

Years of development

10

Countries

700+

Teams supported

5000+

Users worldwide

Major partners

PRODUCTS

Our sw products support the whole process of pharmaceutical development and subsequent portfolio care, thus providing support for both - pharmaceutical development and clinical trial processes and their mutual integration.

PHARMA

CRO

PHARMA / CRO

PRODUCT
MANAGEMENT

gRIS
Development

version 4.0

gRIS
Registration/Launch

version 4.0

gRIS
Portfolio care

version 4.0

CLINICAL TRIAL

ISKO

REMOTE MONITORING

e-TMF

SUPPORTING
SYSTEMS

Global Generic Database

Health, Safety & Environment

Whitebook

Document Management System

Capacity of Equipments

Samples Diary

Products for PHARMA companies

Product Management System (gRIS 4.0)

gRIS is a specific system for pharmaceutical industry allowing fast access andintuitive interpretation of data
It covers all the phases of pharmaceutical development from the management of initial ideas, project execution, clinical testing to registration, launch and manufacturing
gRIS keeps a record of all changes and enables to save all historical versions
Helps to continuously improve processes, improves teamwork, awareness and leads to cost and risk reduction. Therefore increases the competitiveness of the company

CORE MODULES

gRIS
Development

version 4.0

gRIS
Registration/Launch

version 4.0

gRIS
Portfolio care

version 4.0

OTHER MODULES

to be selected according your needs

Timesheet
Portfolio management
Patent analysis
Tasks
Timeline

Launch module
Project diary
Controlling & Reports
Audits
Global Generic Database

Documents
Emails
Trademark module
Initial Target Agreed
Market

Budget
Capacity
Sandboxing
Country scopes
Subprojects

Products for CRO's: Clinical Trial Management - ISKO

System covers 4 sections:

STUDIES PLANNING

Detailed plans of the study, including volunteers, division into groups, randomization, capacity planning for each workplace, materials for the regulator and sponsor

SPONSOR'S MODULE

Collecting online data for the sponsor, remote study monitoring, information about the volunteers, information about the course of study
‍

STUDIES AND VOLUNTEERS
ADMINISTRATION

Project management, input and output examination, study preparation, materials for the regulator and sponsor

STUDIES MONITORING

Clinique operation management, tasks monitoring, reporting the course of the study, AE, making eCRF
‍
‍

Other systems for CRO's:

CDISC - Export Utility

CRS - Clinical Registration System

qRIS - Export Utility

Products for both PHARMA & CRO's:
Clinical Trial Management

REMOTE MONITORING

A system for remote monitoring of the actual progress of the trial, specifically developed for bio-equivalence studies.
In addition to online running studies, the system allows Queries to be added and further responded to, and greatly supports the
integrity of study data and helps to audit it.

e-TMF

Cloudsystem based on the DMS (document management system) allows document managementof clinical trials. This solution provides a remote access and supervised cooperation of all involved subjects - sponsor, CRO, PI.
Access rights and document workflow settings included.
Allactions with documents and their metadata are recorded in the audit trail for audit purposes, and the system guarantees data integrity and proves theirorigin and lifecycle.

Products for both PHARMA & CRO's:
Supporting systems

GGD - Global Generic Database

The GGD system integrates all development centers in one global overview intended for HQ reports and decision making. It provides data (as defined by a user) on the status and cost of all projects with an aim to decideon appropriate project prioritization.

Capacity of Equipment

System for capacity planning of the defined equipment and operators.It enables automation of the resource planning process and monitors its actual use.

DMS - Document Management System

Validated system for document management used in pharmaceutical environment. Integrated with other nDAta systems, but also with SAP and mail.

HSE - Health, Safety & Environment

HSE allows the management of data regarding the substances used in terms of occupational safety and environmental protection. Every time you are going to work with a hazardous substance, you shall be automatically alerted how to hande it.

Samples Diary

Planning, analysing and evaluating of laboratory tests considering the specifics of pharmaceutical development.
‍

Whitebook

A system for displaying the data structure of projects from other systems in the form of dynamic maps.

IT INFRASTRUCTURE

basic system parameters

Used technologies

All nData system are based on latest .NET architecture from Microsoft, offering sufficient flexibility in development work while guaranteeing the highest level of security.

Following technologies are used by nData:

Application server:

DB Server:

Data Analytics:

UI:

Integrations:

Windows Server, IIS Server

MS SQL Server

MS OLAP Server

HTML, WPF

SQA, WCF, Web services

ON -PREMISE

CLOUD

Instaled on customer's servers

Security managed internally

Infrastructure-related costs

Work without external connection

External access depends on infrastructure

Slower deployment

Software as a Service (SaaS)

Security managed by a cloud provider

No initial costs

Internet connection necessary

Easy access from anywhere

Immediate deployment

BUSINESS MODEL

nData offer:

existing ready-to-use products
customization of existing products
tailored made solutions

License fee reflecting:

Type and number of nData products / modules utilized
Amount of client's data supported (e.g. # of projects)

Additional features:

Unlimited number of users
Dedicated team for demonstration, implementation and testing phases
Service level agreement
Software assurance agreement
On-premise software or cloud computing options

WHY TO PARTNER
WITH nData?

REFERENCES

Easy-to-usemodular system enables to define appropriate access rights and efficient datamanagement across modules and gives me considerableadvantage in managing my team‘s activities and capacity in comparison withother tools.

Anna Hanzlikova
Head of RA at PROMED

I just love gRIS!

Özde Ütkür, Ph.D., PMP
Head of Project Management andLaunch Preparation at SANOFI

The nData gRIS system allows us to manage the overall course of development projects more effectively, to do the right things at the right time. Using gRIS leads to continuous improvement of the proces and thus improving the competitiveness of the company.

Bc. Šárka Procházková
Development systems & process support manager at ZENTIVA

All our requests either for customization or updates are dealt with by nData very professionally with high speed and accuracy. They invest sufficient time into the analysis of our needs and they are very experienced in offering solutions which serve our business needs.

Robert Khaddour
IT-Manager at QUINTA ANALYTICA

CONTACTS