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
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.
Health, Safety & Environment
Document Management System
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
to be selected according your needs
Controlling & Reports
Global Generic Database
Initial Target Agreed
Products for CRO's: Clinical Trial Management - ISKO
System covers 4 sections:
Detailed plans of the study, including volunteers, division into groups, randomization, capacity planning for each workplace, materials for the regulator and sponsor
Collecting online data for the sponsor, remote study monitoring, information about the volunteers, information about the course of study
STUDIES AND VOLUNTEERS
Project management, input and output examination, study preparation, materials for the regulator and sponsor
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
- 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.
- 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:
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.
Planning, analysing and evaluating of laboratory tests considering the specifics of pharmaceutical development.
A system for displaying the data structure of projects from other systems in the form of dynamic maps.
basic system parameters
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:
Windows Server, IIS Server
MS SQL Server
MS OLAP Server
SQA, WCF, Web services
Instaled on customer's servers
Security managed internally
Work without external connection
External access depends on infrastructure
Software as a Service (SaaS)
Security managed by a cloud provider
Internet connection necessary
Easy access from anywhere
- 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)
- 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
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.
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.
IT-Manager at QUINTA ANALYTICA