Clinical Research

Structured data collection and management ensuring compliance

Clinical research is an expanding area of study, as academia, government, and industry seek to improve the success rate of clinical trials and the overall efficacy of new medicines, devices, and diagnostic tests.

At the bench research stage, scientists need standard electronic laboratory notebook functionality for recording their chemistry and biology experiments. As compounds progress to the animal testing stage, recording workflows for the handling of animals and materials becomes important. In sample processing laboratories, analysts need a more structured platform to ensure compliance with properly following procedures, accurately documenting results, and accurately tracking samples. Clinical researchers need an ELN to record and manage more general clinical observations and to manage documentation associated with various processes.

These diverse information management needs require an ELN that is versatile and highly configurable to accommodate multiple and divergent workflows, yet robust and structured enough to maintain integrity and uniformity of processes. The ArxLab® Notebook has the flexibility to effectively manage recording of scientific and clinical information from its earliest stages at the bench all the way through to the clinical trials process.

Benefits For Clinical Research

Scientists have full ELN functionality to record discovery research and preclinical safety and metabolism data within ArxLab Notebook. Custom workflows can be deployed to manage sample, animal, and material workflows. Patient questionnaires and approvals, sample protocols, test results, and project plans can be attached to experiments or other workflows. ArxLab Notebook has the capacity to store large data files, such as next generation sequencing data. The ArxLab platform is 100% cloud-based, fostering information sharing throughout the clinical research ecosystem’s network of sites, pharmaceutical companies, and academic research institutions. Biorepositories can be established and groups of patient samples can be linked to experiments for research and testing purposes. ArxLab Notebook has decision support capability so that clinically relevant data can be sorted, speeding clinical decision making. The system is 21 CFR Part 11 qualified and offers full experimental audit trails, digital signing and witnessing capability, and optional support for SAFE BioPharma signatures.

ArxLab® Products

Electronic Laboratory Notebook (ELN)

The ArxLab ® Notebook product is a cloud-based Electronic Laboratory Notebook (ELN) and Workflow solution built to serve as an authoritative repository for Chemistry and Biology data, optimized for the collaborative research models ubiquitous in today’s commercial and academic research environments. It is highly effective at allowing organizations to collaborate and securely share research information with outside industrial partners, academic collaborators, and CROs. The system can deploy in one business day, includes experiment signing/witnessing capability and audit trails, is 21 CFR Part 11 compliant, and offers robust functionality to support chemistry and biology workflows.

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Registration for Chemistry and Biology

The ArxLab® ChemReg and BioReg modules are a cloud-based solution built to serve as an authoritative repository for unique chemical and biological entities. The system handles cases of uniqueness (identity) criteria, mixtures, and cross-referencing, all within a single system that offers unified search across all entities, including chemically intelligent searching when a structure is present. PerkinElmer ChemDraw® is integrated for chemical drawing, and ChemAxon chemical intelligence functionality enables chemical search, property calculations, and full support for salts, mixtures, formulations, tautomers, and all types of isomers.

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Assay

ArxLab® Assay is a cloud-based software tool set that can define, collect, manage, and store assay endpoint data – ideal for assay development functions as well as LTS and HTS screening programs. It provides study coordinators an integrated view of study activity and centrally manages data across multiple research groups and facilities. Users can specify required and optional parameters, data types, allowed ranges, and more. ArxLab Assay can perform automated calculation of raw data values, generate curves and heat maps, and allow for point knockouts for curves.

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Inventory

ArxLab® Inventory is a cloud-based inventory application providing a tool set to natively define and manage inventory items such as proprietary compounds, commercial reagents, samples, consumables, equipment, and other inventory items. Common operations include tracking of receiving, container history, usage levels by user, container location, material check-in/check-out, plate management, and audit trail. User-defined location hierarchy provides for exact locations of stored materials within a building, laboratory, bench-top, freezer, etc. Users can configure container type and storage locations and search by any field, or by chemical structure.

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Decision Support

ArxLab® Search is a decision support tool enabling querying, visualizing, and reporting of data from the ArxLab® Notebook, Registration, Assay, and Inventory modules. It allows users to perform real-time searching and sorting of compound, material, assay, and inventory data, and to customize the layout of these results. Users can save save search and filter parameters, perform basic mathematical calculations, visualize chemical structures, create customizable graphs, generate 2D plotting, perform structure-activity relationship analyses, export tables to Microsoft Excel, and more. ArxLab Search can also integrate with external data repositories, offering data visualization functionality for any client information.

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Workflow

Project and work request management: ArxLab Workflow is a comprehensive project and work request management system, allowing managers to make work requests and track the progress of these requests, as well as of other projects and activities. It allows users to create new work requests and to assign them to users and/or groups. Workflow allows for designation of which users or groups are allowed to: create new requests, view requests, edit requests, delete requests, and be assigned requests. Managers can submit multiple items or requirements for one request/workflow via manual entry or bulk file import.

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Related White Papers and Information

 

Cloud-Based Electronic Notebooks - The New Generation

Download our white paper to learn how Sunovion Pharmaceuticals adopted ArxLab Notebook to transition from paper notebooks internally, as well as to effectively manage incoming CRO data.

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Cloud-Based Electronic Notebooks - Migrating From Old to New

Download our white paper to learn how Constellation Pharmaceuticals replaced its existing client-server installation of its electronic laboratory notebook with ArxLab Notebook, increasing productivity while decreasing support requests.

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