arivis started with the first ever cloud-based eDMS system designed for life sciences in 2005. We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Now arivis Clireo provides the only Azure based Clinical eTMF and ISF with full eDMS capabilities.
And Clireo eMPM supports end-to-end Promotional Materials Management for Medical, Legal, and Regulatory review and approval. Combined with Clireo eCTD and the new Module 1 for the FDA eCTD, Clireo creates the industries only integrated Promotional Materials Management system with integrated eSubmissions capabilities.
arivis started with the first ever eDMS system that integrated Business Process Management (BPM). We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Later we introduced more regulatory submission management capabilities with support for 510k, PMA, and custom submission types.
HIGHLIGHTS
Regulatory documents
DIA EDM Reference Model
Submission signposting
Lifecycle & workflows
Dynamic permissions
Metadata
Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).
HIGHLIGHTS
Scheduling enable the organizations to manage inspections
Mapping and tracking of observations to issues and CAPA items
Track progress and effectiveness of corrective measures
A timely, transparent, and effective communication between sponsors and authorities are paramount during regulatory operations in drug development and can facilitate earlier availability of safe and effective drugs to patients. At the same time, it reduces frictions with later steps in the approval process.
intelligent raw data archiving watcher
Processes, Documents, RAW Data, GxP Lab, Controls, SEND, loT
As well as all other Add-ons ...
intelligent pharma quality management
Processes, Documents, QMS, qDMS, CAPA, Image QC, Issue Management
As well as all other Add-ons ...
intelligent trial master file
Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving
As well as all other Add-ons ...
intelligent regulated content services
Processes, Documents, rDMS, RIM robot, IDMP/SPOR, promo mats
As well as all other Add-ons ...
intelligent and quality conscious archiving solution
R&D, Clinical Data, Non-Clinical, Quality Docs, SDTM, SEND
As well as all other Add-ons ...
When there´s no room for error, you must be able to readily access TMF files ...
Read MoreWhy Data Quality and Integrity should be at the heart of your Quality System ...
Read MoreHow an OS in life sciences can drastically decrease inspection preparation time ...
Read MoreThe 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...
Read MoreCreate more value along the life science processes. neuronOS® offers several ready-to-go applications to increase quality, reduce regulatory and financial risks and to leverage innovation and speed.
Read MoreDo you have questions about how to manage your data since the release of the new OECD guidelines?
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For further information please contact us, we look forward to hearing from you.
