Pharmaceuticals

Secure data management for collaboration and externalization

Life sciences is transforming and the drug discovery paradigm is changing. Many discovery programs are now conducted by external research partners. This rapid change in Pharma’s business model presents enormous data challenges in sharing and security. Secure and flexible data management systems enable collaboration, sharing and innovation across all aspects of the partner network.

Most research labs today process massive quantities of incoming data from collaborative research and, most often, from CRO partners. The geographically separated CRO facilities make hard copy data entry almost useless. If an electronic notebook application is already deployed, it can be difficult, time-consuming and error-prone to review and manually enter external data that is supplied from an alternative lab notebook application.

A primary use case for the ArxLab Notebook is to securely gather data from CROs and seamlessly approve and upload that data into electronic notebooks existing at Pharma. Arxspan provides standard integration to enable this type of workflow. Research managers can view, search and approve CRO experimental data prior to incorporating it into their existing notebook. Optionally, if desired for security, data delivered by ArxLab can be deleted once the data transfer is complete. This approach offers valuable benefits, including:

Benefits For Pharma

Security

CRO users have no visibility into Pharma’s IT infrastructure. This security arises by use of the ArxLab® system as the CRO notebook system and not by configuration or permission changes in existing corporate notebook systems that would jeopardize internal security.

Visibility

Monitor CRO research and collect output electronically, including electronic signatures and witnessing, if desired.

Efficiency

CRO data are electronically pushed to the internal electronic notebook platform, eliminating the time and process of manually entering relevant data.

Compliance

ArxLab Notebook is 21 CFR Part 11 compliant and offers optional SAFE-BioPharma support.

ArxLab® Products

Electronic Laboratory Notebook (ELN)

The ArxLab® Notebook product is a cloud-based Electronic Laboratory Notebook (ELN) 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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