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.
HIGHLIGHTS
Collaborative Authoring
Trial Design
Patient recruitment, screening, and enrollment
Workflow management of the entire protocol's life cycle
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).
HIGHLIGHTS
Study conduct and project management
Monitoring visit reports
Close-out and analytics
Validated Reports, Ad-hoc reports
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?
HIGHLIGHTS
Vendor Management
Investigator Management
Site Identification
Trial Planning and Startup
Site preparation
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.
HIGHLIGHTS
eTMF integration
Archiving
Actual document statuses and updates,
Fully integrated with CTMS workflow events and triggers
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.
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.
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
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.
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.
Complete document management, training management, CAPA, deviations, change control - all in one tool.
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.
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.
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.
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.
For further information please contact us, we look forward to hearing from you.
