niServices

niServices

At niAnalytics we pride ourselves on helping our customers succeed. What better way to do so than by taking care of them from study inception all the way to the final Clinical Study Report (CSR)? To this end, niAnalytics provides full data management and statistical services which free you to concentrate on what you do best, running an efficient and successful clinical trial. As data management is what we do best, our niServices are designed to leverage our expertise.

Our niServices include:

Data Management and
EDC Deployment Services

Statistical
Services

Custom
Solutions

Training
Services

Next Level
Customer Support

Data Management and EDC Deployment Services

Our niAnalytics Data Management services follow you from trial and site set-up, through to the creation of the finished trial database.

Data Management

Key features of our data management and EDC deployment services include:

In-system trial setup
eCRF creation and validation
Validation Report writing
Clinical Data Management Report writing
EDC document creation, including:
Site Initiation Visit Reports
Monitoring Visit Reports
Close-Out Reports
Study Logs
WebPRO
and much more...
Creation of in-system organization structure
Creation of granular roles and permissions for:
Trials
Organizations
Documents
Document types
Document versions
Queries
System Modules
Creation of custom trial and role dependent user manuals
Custom reports and data exports
SDTM Tabulation
Database export
Data preparation and cleaning

When performing trials with us, you will have access to a niAnalytics service specialist dedicated to your organization. We say dedicated to your organization, not trial, as the niAnalytics CTMS allows your organization and trial sites to run multiple trials on a single instance of our system. This makes our service specialists truly your specialists.

Statistical Services

Statistical Services

Combined with our statistical services, you never need worry whether your statisticians will need to adapt data gathered in, and reports generated from, our niAnalytics CTMS.

Our statistical services include:

Sample size and power calculation
Randomization
Statistical analysis plan writing
Statistical analysis
Pharmacodynamic and pharmacokinetic analyses
Population pharmacokinetics
Statistical report writing

Custom Solutions

At niAnalytics we understand that try as we may, it is impossible to create a one size fits all solution, and that you will still need custom solutions. Our team is ready to help develop custom solutions for your specific trial, organization, or institution.

Custom Solutions

Some custom solution requests include:

Clinical or hospital information system integration
Wearable integration
Laboratory data integration
Stock and inventory management
Logistics and shipping management
Shipping based on on-site stock
Custom reports
…and much more

Please do not hesitate to ask if we can integrate your idea with the niAnalytics EDC/CTMS system.

Training Services

Depending on the complexity of the trial, trainings can be held-on site, at a common third site, or via teleconference.

For each trial we create training copies of the required EDC documents so that staff will be trained on the exact tools which they will be using.

If necessary, we can provide in-depth training for your staff if they will be providing training for site staff and/or vendors (train-the-trainer).

Do you need such a system?

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

Next Level Customer Support

We at niAnalytics are responsible for our database back-ups and security, while guaranteeing 99.99% server uptime. Using fully a fully encrypted internet connection you will have access to a secure web domain dedicated not just to your particular trial, rather to your organization. Our niAnalytics support structure provides a specialist or if necessary, specialists dedicated to your organization.

We firmly believe that niAnalytics will become an integral part of your organization. As such, we will work with you to define a communications and escalation plan to ensure all your organization's needs are met at all times.

Of course, you do not need to use all the functionalities or services we provide. Please do not hesitate to contact us and we will work with you to provide a package customized to the needs of your organization and clinical trial.

Next Level Customer Support