eTMF & ARCHIVING

Navigate your entire eTMF in just one simple cloud interface from any desktop, laptop, tablet or mobile and be supported by the industry-standard eTMF Reference Model for document artifacts

 

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BEYOND JUST TRIAL MASTER FILE MANAGEMENT

Are you under a lot of pressure right now? Feeling overwhelmed with tedious paperwork or trying to figure out how to use complicated software? To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study. Thus, it guarantees adherence to GCP-ICH standards and regulatory compliance. However, trial master files can represent a significant challenge in a clinical trial environment, especially if it relies on paper-based systems. Due to the global nature of clinical trials and the large volume of documents generated, the collaboration between stakeholders seems almost impossible. 

Besides, it may be difficult to ensure regulatory compliance thought all the phases of the trial, to recover missing data, and to track the status of document submissions or follow up. All of this is a formula for disaster. When there´s no room for error, you must be able to readily access TMF files to make the best-informed clinical decisions. 

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TRIAL DOCUMENTATION
  • Combine documentation and data from compliance, regulatory and digital imaging in one ecosystem
  • Interactively modify document metadata during upload
  • Identify ‘living’ documents and where they are located
  • Customizable user roles enable easy access at the correct level for all users
QUALITY TRACKING
  • Improve the accuracy of documents with quality check workflows
  • Easy editing of documents with Office 365 integration
  • Single central location for all documents increases visibility and oversight
  • Filter and search for documents by Reference Model zones, sections and milestones
INSPECTION READINESS
  • Always manage documents in one system to stay Inspection Ready
  • Increase Inspection Readiness through quality, timeliness and completeness management
  • Easily navigate to the correct study, country, site, zone, section or document
  • Easy to use and simple structure for instant access and control
VALIDATED & CONTROLLED
  • Ensure GCP compliance with embedded workflows, dashboards and reports
  • Seamlessly integrate eTMF quality processes and workflows into your organizations’ business requirements
  • Standard placeholder templates enable fast access for document uploading

Benefits of arivis5D - Features Overview

arivis5D eTMF is an out-of-the-box, cloud-based solution that includes repositories defined in the Drug Information Association's best practices for Clinical Electronic Trial Master Files (DIA eTMF Reference Model).

Our solution helps you manage all eTMF artifacts more efficiently with a complete cloud-based document management system especially projected to facilitate any eTMF business process. 

 

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  • Simplify and accelerate trial execution. With arivis5D you can navigate your entire eTMF in just one simple, cloud interface from any desktop, laptop, tablet or mobile.
  • Easy interaction between Sponsors, CROs and Sites. arivis5D provides a secure and collaborative space for your team to share and exchange eTMF content by allowing users to manage document completeness in real-time. 
  • Be ready for inspection. You won´t have to worry about inspections anymore. arivis5D offers an easily accessible eTMF to facilitate audits & inspections with more confidence than ever. 
  • Identify missing documents and artifacts in minutes, not months. See where documents are Expected or Completed to gain more time to focus on your patients. 
  • Manage Study, Country and Site progress as it happens. arivis5D allows you to track trial progress efficiently.
  • Use bulk import processes to allow uploading of multiple documents to the correct artifact placeholders.
  • arivis5D supports the industry-standard eTMF Reference Model for artifacts, properties, relationships and hierarchies of all documents

Thats why arivis5D eTMF is the best solution for your company.

arivis5D eTMF includes inspector portal, quality check workflows, version control, document staging areas, FTP connectivity, and a full standards-based API. Easily add arivis5D eCTD for global regulatory e-submissions. arivis5D is easy to use and is supported by one of the most user-friendly and more cost-effective licensing models amongst eTMF software providers. This means, with arivis5D you can save time and money to focus on your research. 

Don’t worry about a thing. In addition to software, arivis provides comprehensive professional services encompassing everything related to your eTMF. You can feel secure in our hands. arivis focuses exclusively on Life Sciences and has deployed eTMF solutions for companies of all sizes. It’s time to consider the best solution for your eTMF, and that solution is arivis5D eTMF.
The Power of 5D

Data
Dossiers
Documents
Digital Forms
Digital Assets

Our applications span the entire lifecycle through drug discovery, development towards market access and continuously leverage innovation

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RESOURCES

Related Processes

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Audit Management

The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company.

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CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally. 

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Change Control

Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management rewards the company with improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture. 

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Deviations Management

The management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and Process Deviation Management.

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High Content Screening

High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in early development stages and drug discovery to typically identify substances such as small molecules, peptides, or relevant RNAi that can lead into development candidates for future medicines. 

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Image Annotation

With the development of diagnostic imaging devices, large amounts of digital high-res and 3D images are generated every day. The requirements of effective indexing and searching image are growing rapidly. Image annotation is an effective way for content-based image retrieval. 

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CRO Collaboration

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. 

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Remote Image Analysis

Imaging data in diagnostics and research is growing at an unprecedented rate, coming from all kinds of sources. The con-focal and high-resolution microscopy, artificial intelligence, and any other new computer-tomographic (CT) technologies create vast amount of data. 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. 

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Inspection Management

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).

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SOP Management

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.

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Raw Data Management

A clear understanding of how RAW DATA is defined, recorded, and retained in the laboratory record is essential when it comes to compliance with the Good Laboratory Practices regulations. RAW DATA in laboratories occur in various fluctuating formats and versions in a large amount of laboratory devices, LIMS and quality management systems. 

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Training Management

Post implementation training services relate often to process changes. With arivis training services implementations are ready for success. The arivis5D Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations. 

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eTMF and Archiving
To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.
Read More
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CONTACT US

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

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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.

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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.

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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

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Real-time indicators on all levels
Intuitive navigation in various dimensions based on metadata
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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

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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

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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

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Access control
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File versions
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Integr. electr. long term archive
Instrument monitoring

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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
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Exploration of Results overlaid on raw data
Interactive rendering of volumes and time-series
Cinematic high-resolution rendering

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Smooth Rendering and Visualization
Collaboration via different VR Scenarios
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Export Snapshots, Movies and 360°
Seamless Exchange with Desktop Application
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Magic Wand Tools

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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
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Visualize massive image volumes via remote rendering servers
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INDUSTRIES

Biotech

The broad concept of “biotechnology” or also known as "BioTech" encompasses a wide range of procedures. The global market for the biotechnology market is primarily driven by technologies like DNA sequencing, nano-biotechnology, tissue engineering and regeneration, cell-based assay, PCR technology, and others. Explore the flexible solutions for emerging BioTech

 

Pharma

The pharmaceutical industry develops drugs or devices to diagnose, cure, treat or prevent diseases. Pharmaceutical companies produce both generic and branded drugs. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Pharmaceutical drugs are intended for human or veterinary use presented in their finished dosage form. Learn more about the Process excellence of arivis in Big Pharma.

 

CRO

A contract research organization (CRO) is a company that offers services to the pharmaceutical and biotechnology industries. These companies partner with various companies and organize and conduct clinical trials to test the new molecule before obtaining approval. Contract manufacturing organizations (CMO) offer manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trial purposes and commercialization. See how arivis enables functional service provision with CROs.

 

CMO

A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overhead. Arivis offers solid solutions for contract manufacturing.

 

GLP Laboratory

Third-Party Laboratories for GLP Testing, contract testing laboratories. Pharmaceutical manufacturers contract out any quality control testing, will need a licensed laboratory, certified as a GMP or GLP. The GLP laboratories are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. With a arivis you are committed to integrity with contract testing laboratories.

 

Academic Institutions

Institutions in this industry offer academic and professional courses and confer baccalaureate or graduate degrees. In the US major institutions include public university systems in states such as California, New York, and Texas, and private universities such as New York University, Duke, Harvard, and Johns Hopkins. arivis cultivates long term partnerships in academic research.

 

Diagnostic Microscopy

Microscopes have enabled researchers to conduct in-depth academic and exploratory research. The biomedical research and engineering sector is driving innovation by microscopy techniques to produce better and more informative images of cellular functions, including internal images of cells.