About niAnalytics

About Us

niAnalytics was founded in Zurich, Switzerland, in 2012 by a group of clinical trial professionals who were frustrated with the costly and time-consuming rigid tools available. We decided to develop the necessary approach and system capabilities to conduct studies more efficiently while allowing for more flexibility and customization.

The result is our niAnalytics EDC/CTMS system that minimizes clinical trial data management setup time, including eCRF, data collection, verification and statistical analysis.

Vision and Mission

Our vision is to increase the variety and the quality of available medical treatments by reducing the overall pharmaceutical lifecycle and related cost by constant improvement of clinical trial processes.

niAnalytics strives to become the premier EDC solution provider by adding unmatched value to customers through expertise, dedication, innovation, and care.

Values

Adherence to professional standards is a necessary requirement but it represents only a first step towards what we believe in. We demand honesty and absolute confidentiality from all our employees in everything they do, no matter if they interact with customers or colleagues.

Ownership & Reward

We strongly believe that ownership for all responsibilities, be it client related or internal, is key in order to realize the desired results and therefore to any valuable relationship. We expect leadership from each employee, resulting in a responsible use of all our stakeholders’ resources. We expect consistent professionalism and excellence of performance from our employee and reward it accordingly.

Compliance

niAnalytics™ was built for conducting clinical studies and it therefore complies with all relevant regulatory requirements as:

CDISC - clinical data interchange standards consortium
21 CRF Part 11 - an FDA guideline on electronic records and electronic signatures
HIPAA - the Health Insurance Portability and Accountability Act by the US Congress
GAMP 5 - guidance for the validation of automated systems in the pharmaceutical industry
GCDMP - Good Clinical Data Management Practice

niAnalytics™ fulfills all necessary requirements for use in clinical trials. Additionally, it can easily be validated as a productive system in a clinical setting.

We will gladly assist you in carrying out a vendor audit. Our preferred third-party auditors are also readily available to accompany the process if required.

CDISC

GAMP 5

GCDMP

21 CRF Part 11

HIPAA