NON-CLINICAL

NON-CLINICAL

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Basic principles

From Probability to Success

The non-clinical (or pre-clinical) development phase primarily aims to identify which candidate therapy has the greatest probability of success, assess its safety, and build solid scientific foundations before it comes to testing humans. The non-clinical development process starts in parallel with research activities, and non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic and toxicokinetic characteristics of drug candidates. Optimized non-clinical development is an important success factor for later clinical development. Data analysts, project and vendor managers, and report writers need to stay on top of all documentation along the process and need to deliver in later phases and into the eTMF for further reference.

  • Non-clinical / Pre-clinical Project Management
  • Planning and Tracking along Drug Development Plans
  • Management, documentation and reporting of non-clinical programs, projects, studies (GLP) e.g. ADME, PK/TK & Tox, including CRO selection
  • Pharmacokinetics and Toxicokinetics (PK/TK) (GLP)
  • Preparation of Non-clinical Regulatory Documentation & Reports (IND, IMPD, IB)
  • Non-clinical (Preclinical) Process Consultancy

arivis-drug-discovery-cro-collaboration

CRO Management

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity. Properly designed CRO Collaboration opens capabilities in various functions like the following:

HIGHLIGHTS

  • Pharmacovigilance
  • Medical Writing
  • Statistical Programming
  • Site Management
  • Regulatory Affairs
  • Regulatory Operations
  • Biostatistics
  • Data Management
  • Translational Medicine
  • Medical Affairs
  • Clinical Monitoring
 

arivis-non-remote-image-analysis

Remote Image Analysis

When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections the bandwidth and computation power easily exceeds the capabilities in remote areas.

HIGHLIGHTS

  • 3D organotypic culture models
  • Microplates
  • Automation and liquid handling
  • 3D imaging
  • 3D image analysis
 

arivis-quality-SOP-management

SOP Change Control

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:

HIGHLIGHTS

  • Objective (Purpose)
  • Scope
  • Responsibilities
  • Accountability
  • References
  • Task Instructions (Procedure)
  • Documentation
 

arivis5D Platform

arivis5D-imaging

product-image-arivis5D-imaging

Comprehensive Imaging Science solution for research and production imaging processes.  Process support that covers the whole workflow from imaging to conclusions. Improve and integrate image production, data ingestion/archiving, storage, access, analysis strategy, QA/QC, computation at scale, review of results, and implementation of custom algorithms and AI.

Configurable by subject matter experts
Scripting interfaces
Workflows for optimization at every step
Accelerated computation for projects
Results in space and time on image volumes
Access any portion of image at any time
Connect datasets & results across projects

arivis5D Platform

arivis5D-compliance

product-image-arivis5D-compliance2

Quality Management System with features to secure and control data & documents. Collaborative platform for regulated content, processes and end-to-end compliance along the complete life sciences life cycle. Powerful and intuitive navigation, enhanced user experience, dynamic content management and search features. Connecting quality teams globally.

Controlled assets and documents
Collaborative platform for regulated content
Processes and end-to-end compliance
Workflows along the complete life sciences life cycle

arivis5D Platform

arivis5D-protocol

product-image-arivis5D-protocol

Trial Master File solution to securely review and audit TMF documentation. Digital process support with form-based workflow for the complete (pre-) clinical document processes. Visualize real-time completeness based on study, country and site indicators. Apply filters and different dimensions, view metadata to intuitively navigate through complex eTMF filings

Audit savvy Trial Master File solution 
Digital and process centric approach
Real-time indicators on all levels
Intuitive navigation in various dimensions based on metadata
Fully integrated with CTMS workflow events and triggers

arivis5D Platform

arivis5D-information

product-image-arivis5D-information

Document and project management solution for life science. Tools for operations and oversight teams to prepare and review documents and records for the completion and successful submissions and correspondence. User centric collaboration, automation and quality workflows featuring the life cycle of documents and dossiers from authoring to (re-) submission.

Document, asset- and project management
Operations and oversight
Collaborative review for submissions and correspondence
Automation and quality workflows from authoring to (re-) submission

arivis5D Platform

arivis5D-rawdata

product-image-arivis5D-raw-data

arivis BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry.  It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems. arivis BM-Watcher is an agent that is able to monitor the file storage of a laboratory device. 

Access control
Audit trails
File versions
Electronic signature Lifecycle
Automated indexing of all data
Integr. electr. long term archive
Instrument monitoring

On Premise

BM-Flow

product-image-BM-Flow

Complete document management, training management, CAPA, deviations, change control - all in one tool.

Inbox for all types of tasks: documents, QA processes, training
Configurable document workflows
Configurable forms, workflows and reports for CAPA, deviations, change control (and many more)
Digital signatures - certificate based. No third-party tools required.
Training plans, training organization, reports on trainings
Quiz module

On Premise

BM-Watcher

product-image-BM-Watcher

arivis BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry.  It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems.

Access control
Audit trails
File versions
Electronic signature Lifecycle
Automated indexing of all data
Integr. electr. long term archive
Instrument monitoring

arivis-Vision4D

teaser-Vision4D

Modular software toolkit for extracting results from scientific images. Adjusts to hardware for maximum power and smooth interactivity on image datasets of unlimited size. Brings diverse tools into one environment and enables users to connect them into productive workflows. Highly interactive for optimization and quality at every step. Extendible directly via Python and connectable to other applications via libraries.

Tile Stitching
Data Transformation
Image Preprocessing & Enhancement
Segmentation
4D Tracking & Lineage
Batch application of Analysis Pipelines
Custom Computed Features of Objects
Exploration of Results overlaid on raw data
Interactive rendering of volumes and time-series
Cinematic high-resolution rendering

arivis-VisionVR

teaser-VisionVR

Display real image data in Virtual Reality by utilizing patent pending direct volume rendering techniques with no need to convert data or make surface models. Directly use your hands to move, rotate, scale, and shape your digital image data. Interactively proofread, edit, track or segment multi-dimensional images from nearly any source instrument.

 

Smooth Rendering and Visualization
Collaboration via different VR Scenarios
Direct Volume Rendering
Export Snapshots, Movies and 360°
Seamless Exchange with Desktop Application
Sculpting Tools to Add, Delete and Proof-read
Magic Wand Tools

arivis-VisionHub

teaser-VisionHub

A nucleus of computational activity and collaboration at scale. VisionHub enables design and execution of large-scale experiments that produce results from images, whether datasets are already stored or are actively being produced. Mass quantities of Imagery are onboarded and processed by a virtual team of computational workers. Smartly utilize processing cores in servers or workstations with the maximum speeds possible.

Register and browse image and data
Manage access for users and groups
Import and archive datasets into the arivis framework
Create experiments that produce results at scale
Leverage computational resources onsite and offsite
Scalable pricing model to support bursts of throughput
Visualize massive image volumes via remote rendering servers
Implement quality checks for increased efficiency and validity
Smart optimization of parallelization

CUSTOMERS

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