niAnalytics Clinical Trial EDC / CTMS with Data Management and Biostatistical Services
niAnalytics GmbH provides a unique combination of software and services that facilitate efficient and effective electronic data capture and data management for clinical trials. The niAnalytics system is composed of two parts, our custom niAnalytics EDC / CTMS software and our specialised niServices.
The niAnalytics EDC / CTMS is a unique integrated software-as-a-service (SaaS) solution designed for all clinical trial types and organisations. It was created to expedite the composition, storage and retrieval of eCRFs, databases, as well as any and all clinical trial documents.
The system integrates EDC (of which eCRFs are only a special case), Double Data Entry, WebPRO, Source Data Verification, integrated advanced Query Module and metrics, automatic trigger, query and assignment generation, as well as adverse and serious adverse event (AE and SAE) reporting and categorisation. The system has been built to adhere to the latest clinical data standards, including CDISC and Good Clinical Data Management Practice.
Accessible from any browser, the niAnalytics EDC / CTMS supports all languages while supporting multiple trials in a single instance, so all studies and associated documents are accessible from one login. Users can have various roles with different permissions for different trials, with access to system modules and reports across those trials simultaneously.
We also provide our complete suite of niServices which have been developed to complement the niAnalytics EDC / CTMS and to further expedite clinical trial completion and market authorisation.
Data management and EDC deployment services for clinical trials
Our data management services begin at trial setup and finish with the final trial database. Services include eCRF, user and site creation, as well as the creation, deployment and control of any type of read-only or EDC document.
niAnalytics services also include data management setup, eCRF validation and validation report writing, clinical data management plan writing, creation of granular user roles and permissions for trials, organisations and document types and versions. We create custom trial and role dependent user manuals, custom reports and data exports, Study Data Tabulation Model (SDTM) tabulation and database export, data preparation and cleaning.
As customers can simultaneously run multiple trials on a single instance of the system, we provide a dedicated niAnalytics service agent for each customer.
Biostatistical services for clinical trials
At niAnalytics we provide our clients with a comprehensive set of biostatistical services. Our team includes PhD-level researchers specialised in medical statistics, pharmacokinetics and pharmacodynamics, as such we can fulfil any biostatistical service or request.
We routinely provide sample size and power calculations, randomisation, Statistical Analysis Plan and Report writing, and full trial statistical analysis, pharmacokinetic and pharmacodynamic analyses, and population pharmacokinetics, and more.
Sample size, power and randomisation in clinical trials
Our niAnalytics EDC / CTMS includes a Sample Size and Power calculator for all to use.
Additionally, our system is pre-programmed with the most common randomisation types used in clinical trials, including simple randomisation, random sorting and random sorting using maximal allowable percent deviation, as well as Efron’s Biased Coin and Smiths’ and Wei Urns randomisations. Additional randomisation methods can be programmed upon request.
Our expert medical writers work efficiently and professionally to write essential data management related trial documents using data generated in the niAnalytics EDC / CTMS, and analysed by our biostatisticians.
The seamless information flow results in an unprecedented level of efficiency and fidelity when writing Statistical Analysis Plans, interim statistical analysis reports or final Statistical Analysis Reports for inclusion into clinical study reports.
Despite best efforts, it is sometimes not possible to create a solution to every requirement, thus certain trials or customers may require custom solutions. Our team can develop custom solutions for individual institutions, organisations or trials.
Specific requests include clinical or hospital information system integration, wearables and laboratory data integration, as well as stock and inventory management, logistics and shipping management and custom reports.
About our services
We strive to be the premier clinical trial EDC and data management solution provider by reducing clinical trial lifecycles and costs.
Our complete vertically integrated data management strategy follows our customers from clinical trial protocol design, creation and implementation of the eCRF and EDC documents to statistical analysis planning and report writing.
Contact us to see how we can help your clinical trial succeed.