F.A.I.R.

VERSATILE AND DATA DRIVEN PLATFORM

Connect the Dots in Life Science and Improve Excellence in Pharmaceutical Development Processes

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Faster Time to Market

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Smarter Decisions

quality

Better Quality Culture

The disruptive shift in Biopharmaceutical landscape due to even more decentralization, the trend towards biologicals and the expected shorter development times for medicinal products (after Covid-19) lead to a new demand in the life sciences industry: The need for modular, more versatile and data driven platforms.

Existing and legacy solutions lack connectivity, are partly redundant, and dispersed and handled separately and disjointly by often disconnected staff members. Important decisions are based on what local staff can oversee. Important data is still shared via email and stored redundantly in excel spreadsheets or SharePoint across the corporations or even only in local or regional departments.

This manner of storage often leads to hardships with regards to how the data was managed, updated, and shared; when data needs to be updated, all copies must be updated manually with great care so that out-of-date information is not kept and recirculated through defined processes.

With neuronOS and the integrated FAIR principles on platform level, customers may overcome problems or findings related to missing consistency and data integrity in a systemic fashion.

The neuronOS approach is the service-based or service-oriented architecture, at its essence. With this change in paradigm – away from tightly coupled applications that focus on the user interface – neuronOS as a platform rather exposes the underlying business functions as connected services which can leverage complexity in nearly every process landscape in the life science industry.

Users in their roles can start using the platform after role assignment and limited training-effort. The platform will set some access rules and security roles which users will need to follow. The platform has several modules, data models and add-ons that are interdependent, thus a careful implementation plan with process review is recommended.

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CAPTURE

Acquire your raw data through machines, interfacing APIs and manual form-based entries.

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REVIEW

Throughout the lifecycle of assets and data documents, value is increased by aggregating and reviewing information.

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MANAGE

Manage your data with neuronOS®. Each data element in the lifecycle has an expected and controlled lifetime. Regulations and processes determine storage and access at any time, from creation through numerous stages to long-term archiving and finally deletion.

Our applications span the entire lifecycle!

Through drug discovery, development towards market access and continuously leverage innovation.

 

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DO NOT LOSE THE THREAD AND PULL THE RIGHT STRINGS

The amount of raw-data has increased year by year in drug research and development. New technologies and simply the available storage have created mountains of unstructured data that cannot be assembled by a simple human interaction.
At the same time, regulatory requirements are forcing companies to keep track of the created data, ensure data integrity and to control the retention.
The value lies in the data, so you should be able to find your data, be able to access, to inter-operate and to finally re-use data at any time in your product life cycle.

Collecting data at the point of creation, enrichment with context and annotations, even supported by machine learning and artificial intelligence all in fully controlled process flows, subsequent quality-checks, evaluation, validation and later archiving.

Untangle your Data and follow the data in your decentralized universe.
Pull the right strings! Be ready for any inspection! Access data easily!

A CLOUD TO BE

All digital, decisive, compliant, and inspection-ready

Given immense pressure on Pharma-, Biotech- and Medical Device markets, Life Scientists must develop innovative new drugs without friction, each with a considerable advantage. Corporations and sponsors face an unprecedented need for speed, consistency, and compliance. 

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Bridging the Gap between Pharma and Science

Todays incredible scientific work based on new powerful tools and data. Images evolve faster than IT. Scientists have the motivation to test, measure, evaluate and not to waste their time with quality assurance like documenting, registering or countersigning.

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TOP 5 CHALLENGES FOR 2021

  1. Catch-up with Corona aftermath (faster) 
  2. Smarter decisions (data-driven)
  3. Better quality culture (inherent compliance)
  4. Identify the risk drivers (predictive analytics and models)
  5. Keep data integrity (consistent documentation)

WHAT IF A PLATFORM CAN BRIDGE THE ENTIRE PROCESS END-TO-END?

Sustainable success in the modern era lies beyond standalone streamlined processes. Everything is now interlinked. More than ever, all technical processes rely on imaging. Images are the heaviest data storage and computational burdens of the modern technology organization and hoard vast untapped information (at unmeasured costs).

neuronOS is based on a keen awareness of the drivers in pharmaceutical development; prudently disrupting or blending in. It is built specifically to support Advanced Analytics on Big Data and enable Artificial Intelligence on multiple levels to increase speed and enable the right data-driven decisions. Instead of being slammed by frequent regulatory waves, organizations neuronOS to ride on top of them.

Enabling a smart digitization from early stages onwards by utilizing metadata in all asset types, in big data volumes from screenings, 2D/3D imaging and annotation processes
Understanding success factors in Clinical Trials and Regulatory Submissions increase the probabilities and enable early attrition by predictive analysis.

Turning massive data into valuable information which can lead into earlier decision readiness. Making the right decisions early is paramount. Understanding fundamental functional patterns manifest in digital forms and workflows which are core principles of the biomedion approach - all with quick and data-driven decisions in mind.

Raw data in early research and later GxP requirements in Pharma

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Looking at something that has never been seen before firstly needs high flexibility. Secondly, producing the right data. And finally, developing real-world medicinal products. As images evolve faster and faster, scientists need high traceability, digital annotations and full integrity of all data along the way to a greater extent.

iRAW plus the various add-ons enables you to collect raw data at the point of creation, lets you enrich the data with context and annotations, and make the information and data available for GxP conform evaluation processes and archiving. 

 

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Why biomedion

biomedion has a successful track record in solutions for research and drug development, quality and regulatory solutions and also a native backend of partners for scaling. Agile software development principles for the neuronOS platform and imaging products using SCRUM and DevOps enable truly continuous development cycles. Customer and market-centric product management that uses subject matter experts as product owners to incorporate a diverse industry know-how.

Data-driven excellence

Life Science players in Pharma, Biotech and Devices, as well as CROs and drug manufacturers are more likely to achieve desired outcomes, if they make decisions early and based on research and data evaluation.

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Full explanation of Software Icons

5 DIMENSIONS OF SUCCESS

You will find these dimensions reflected in each of the predefined applications. The applications are focused on different processes and functions along the research and development life cycle and can handle a broad variety of digital assets, data, dossiers, documents and digital forms.

Building a successful platform is more about making the right trade-offs than it is about technology. To understand the trade-offs, and find the smart direction you have to make the right decisions on what kind of platform you are building. For neuronOS, we asked our customers and the subject matter experts involved in our projects to understand what makes a good platform for tomorrows life science organizations. 

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PROCESSES

  • Clinical Processes
  • Regulatory Information
  • Compliance Framework
  • Big Image Data
  • Raw Data

CORE

  • Learning
  • Forms
  • Reports
  • Workflows

ASSETS

  • Data
  • Documents
  • Dossiers
  • Digital Assets / Imaging
  • Digital Forms

PLATFORM

  • Secure Data Hub
  • Cloud / Big Data
  • Office 365 / Teams
  • Partners / OEM
  • Consultants

SERVICE

  • Professional Services
  • Validation
  • Training and Support

“Our applications span the entire life cycle through drug discovery, development towards market access and continuously leverage innovation”

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iRAW


intelligent raw data archiving watcher
Processes, Documents, RAW Data, GxP Lab, Controls, SEND, loT

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As well as all other Add-ons ...

iPQM


intelligent pharma quality management
Processes, Documents, QMS, qDMS, CAPA, Image QC, Issue Management

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As well as all other Add-ons ...

iTMF


intelligent trial master file
Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving

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As well as all other Add-ons ...

iRCS


intelligent regulated content services
Processes, Documents, rDMS, RIM robot, IDMP/SPOR, promo mats

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As well as all other Add-ons ...

iARQ


intelligent and quality conscious archiving solution
R&D, Clinical Data, Non-Clinical, Quality Docs, SDTM, SEND

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As well as all other Add-ons ...

COMPLETE FLEXIBILITY TO BRIDGE THE ENTIRE PROCESS END-TO-END

Various flexible Add-ons emphasize fully flexibility, collaboration and compliance to bridge the entire process end-to-end

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CONTACT US

For further information please contact us, we look forward to hearing from you.

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