ObserNIS

OBSERNIS is your electronic Trial Master File

Simple Guide For Observational/Non-Interventional Studies.

OBSERNIS is a unique and innovative approach to setting up a non-interventional or observational study. We have carried out a detailed research of the definition of the type of study and we have found that there is no simple unification.

As a result, we have developed a special algorithm that can help you define a study type according to EU and US legislative regulations with a simple wizard.

Define a Study Type

  • Unique algorithm which can help you define a study type
  • Simple wizard
  • According to international guidelines

Calculate a sample size,

make a statistical plan

  • Make statistical plan
  • Calculate sample size
  • Organize your study

Generate a protocol

  • Change your chapters as you want
  • See protocol history
  • Personalize your protocol

Key Features

  • Study type definition

    A set of simple questions can help you define your study type.

  • Documents management

    Helps you create study documents on spot or upload your own documents.

  • Trial Master files on cloud

    You have tessential documents in one place. Anytime. Simply share with your colleagues.

  • Safe your budget

    You can buy any part of our services or order a specific consultation.

  • Collaboration with colleagues

    You can share easily project with your colleagues through specific rules or share with anybody for reading.

  • Generate Protocol

    Define your structure, language, chapters easily and generate your specific protocol for clinical study..

  • Calculate your Sample size

    No need to have special statistical software. You can generate Sample size automatically.

  • Legislation compliance

    No need to go through heavy legislation, we have done that for you.

Pricing

We support science and research, and we are bringing a solution that will help simplify the administrative burden at a unique price. We are pleased with each new healthcare project. Your Healthy Data.

Free

1 project
  • Study definition wizzard
  • Trial master file
  • Document upload
  • Protocol generation
Free
Recomended

Professional

Unlimited number of projects
  • Study definition wizzard
  • Trial master file
  • Document upload
  • Protocol generation
  • Team sharing
  • Own logo
  • Own chapters
  • SAP automated
13
Per user/month,
billed annually
pricing

About us

We are Institute of Biostatistics and Analyses Ltd, a spin-off company of the Masaryk University.

By the years of experience with managing clinical research projects and helping to set them up, we have noticed how the cumbersome procedures in the projects wrinkle up our client’s foreheads. As we also focus on computer automation, we have decided to iron them out by releasing ObserNIS as our brand new product, hence sharing some of our hardly-gained know-how with those seeking for help. If you want to know more about us, please refer to our website.

about-us
  • Real world evidence

    We breathe life into research based on real world data.

  • Over 10-year
    experience in the field

    For more than a decade we have been dealing with observational/non-interventional studies, EHRs, registries, etc.

  • Compliant

    ISO/IEC 20000-1:2006, EN ISO
    ČSN EN ISO 9001:2001/2009, ISO/IEC
    27001:2006.

References

Abbvie Amgen AstraZeneca Baxter Bayer Boehringer Ingelheim Brislot-Myers Squibb GlaxoSmithKline Lilly Merck Novartis Novo Nordisk Pfizer Roche Sanofi Takeda Teva

Contact Us

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Institute of Biostatistics and Analyses

info@biostatistika.cz+420 515 915 100

Define a study type

We created a unique and innovative approach to setting up a non-interventional or observational study. We have carried out a detailed research of the definition of the type of study and we have found that there is no simple unification.
As a result, we have developed a special algorithm that can help you define a study type according to EU and US legislative regulations with a simple wizard.

We have tested it on many types of studies and gone through the national legislation of European countries.

Define a study type

Sample size calculator

We have developed special tools to help you calculate the sample size of study easily. You only need to know a few basic information about the study.

You set the statistical significance and our calculator will calculate how many subjects you have to take into the study.

Generate protocol

If you fill in all the chapters needed to generate the log, you can generate a full version of the log to your pdf, including your logos, order of chapters, names, new chapters, attachments.

It's easier than that, it can not. You are given the individual versions you can view at any time. In Obsernis, you see the changes made by the previous user, the change management rules are applied.

Study type definition

A set of simple questions can help you define your study type.

Because it is not easy to accurately determine the type of clinical trial or registry, we have developed a unique algorithm that will guide you through the definition process easily and simply.

Defining the definition is affected by a number of questions such as the number of centers, the number of countries, the reason for the study, the primary goal...

The definition of the type of study affects the further documentation you need to prepare for each project. As well as administrative and regulatory authorities (eg Ethics Commission, Drug Commission ...).

Define a study type

Documents management

Helps you create study documents on spot or upload your own documents.

For each project you need a large number of documents that can be changed, refilled, created during the study. It often happens that the auditor will find that the investigator does not have all the documentation together.

In Obsernis, you have all the documents together, with the possibility of auditing a trial.

You will see all versions and changes. You can share projects, set permissions. Standardized by ISO 9001 methodology.

Try how simple it is!

Trial Master files on cloud

You have all essential documents in one place. Anytime. Simply share with your colleagues.

The protocol and related documents form the basis of the Trial Master File that you should have for each study. Today's web platforms provide accessibility from anywhere without regard to devices (PC, Mac, Phone).

Our application is responsive and easy to use. Your data is safe and protected according to ISO 27001. Easy and secure sharing of projects. You can set specific rights for a project within a team or with outsiders.

Safe your budget

Thanks to using this app you can share your budget.

Normally, the cost of drafting the protocol is in the order of thousands of euros. With Obsernis, you can create all the basic documents at a unique price. This will be appreciated especially by people from the academic area, where they will not prepare the project proposal and then ask for support.

If you want help from us, you can buy any part of the service or consultation. We will be glad to help you.

Try how simple it is!

Collaboration with colleagues

You can share easily project with your colleagues through specific rules or share with anybody for reading.

Are you a team and do you need to share individual projects with each other? Do you need to share a stand-alone project with someone just reading? For example, with a potential sponsor? Share a separate link or the whole project, it's up to you.

You have full control over individual projects.

The team leader or internal auditor has an overview of what is happening in the projects. You can filter projects, sort them.

Generate Protocol

Define your structure, language, chapters easily and generate your specific protocol for clinical study.

If you fill in all the chapters needed to generate the log, you can generate a full version of the log to your pdf, including your logos, order of chapters, names, new chapters, attachments.

It's easier than that, it can not. You are given the individual versions you can view at any time. In Obsernis, you see the changes made by the previous user, the change management rules are applied.

Calculate Sample size

No need to have special statistical software. You can generate Sample size automatically.

We have developed special tools to help you calculate the sample size of study easily. You only need to know a few basic information about the study. You set the statistical significance and our calculator will calculate how many subjects you have to take into the study.

Legislation compliance

No need to go through heavy legislation, we have done that for you.

Each study must meet local legislative requirements in that country.

We have prepared an overview of all the national authorities you can contact, including important contacts (email, phone, web, address). Obsernis also includes a number of templates and documents that should be included in the study.

You will find a pattern of Informed Consent and many others.

Try how simple it is!

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