Essential documents and the conduct of a clinical trial

A successful close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files. In order to be quick in the study close-out, these Trial Master Files should be established at the very beginning of each trial, both at the investigator/institution’s site and at the sponsor's office. Today, with an biomedion eTMF system, this critical task becomes easy to track and report. With that in mind, its priority to keep up with patient recruitment over distance, the adoption of technology, and regulations and eventually saving costs at the same time. Beside the common factors, COVID-19 draws a new class of challenges to clinical trials in 2020 (read more in Nature, as of 18 May 2020).

Typical challenges for running trials in 2020 are: 

  • Increasing complexity of trials
  • Changing regulations, also COVID-19 related Interims regulations
  • Cost of trials at all-time high
  • Patient recruitment and retention
  • Hiring and training of trial staff
  • Acceptance gain caused by technology
  • CROs, partnerships and oversight
  • New drugs, new ways of running trials



Trial Startup

Study startup remains in focus, because it has still such an impact on clinical trials — and can be considered as part of the critical path to the success of a medicinal product. Any problem with the study startup, more than any other aspect of a clinical trial, draw a substantial risk to increase timelines and budgets. 


  • Collaborative Authoring

  • Trial Design

  • Patient recruitment, screening, and enrollment

  • Workflow management of the entire protocol's life cycle


Trial Conduct

The highest priority in terms of compliance while conducting clinical trials is protection of human subjects and patients. Compliance issues like protocol deviations or violations in the clinical trials remain an issue. Current findings in regard to trials conduct show the need for tools to endure quality and data integrity not only to fulfill the Code of Federal Regulations (CFR). 


  • Study conduct and project management

  • Monitoring visit reports

  • Close-out and analytics

  • Validated Reports, Ad-hoc reports


Trial Site Management

Clinical trial sponsors face many challenges in clinical trials – including how to mitigate risks that could cause delays and increase trial costs. What are some of the challenges that sponsors and CROs currently face when managing trial performance? How can sponsors and CROs use technology to overcome these challenges?


  • Vendor Management

  • Investigator Management

  • Site Identification

  • Trial Planning and Startup

  • Site preparation


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.


  • eTMF integration

  • Archiving

  • Actual document statuses and updates,

  • Fully integrated with CTMS workflow events and triggers

neuronOS Platform



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

neuronOS Platform



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

neuronOS Platform



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

neuronOS Platform



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

neuronOS Platform



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. 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



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 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



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
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



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



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





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

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"Medicine is a science of uncertainty and an art of probability"