Industries Overview

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 Arxspan 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 Arxspan can be deleted once the data transfer is complete.

This approach offers valuable benefits, including the following list.

Security

CRO users have no visibility into Pharma’s IT infrastructure. This security arises by use of the Arxspan 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

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

Fueling innovation productivity is a key to success in R&D. Intensive environments and effective data management is paramount in this age of collaboration.

Arxspan’s cloud-based Arxspan ELN, Arxspan Registration, Arxspan Inventory and Arxspan Assay system is a research-centric knowledge management platform that can help an organization realize the value of its data during this age of information explosion by ensuring quality, consistency and secure access. Its straight-forward turn-key web-browser solution eliminates IT pain for start-up Biotechs have suffered in the past.

Find some of the benefits of the Arxspan Laboratory Software Solutions listed here.

Security

An organization’s most valuable asset is the IP from its research, be it internal or out-sourced. Data standards, security and compliance with 21 CFR Part 11 are included in the software.

Data Integrity

Low cost data migration from legacy systems is performed by the Arxspan team of professionals.

Visibility

Secure uniform data storage eliminates problems caused by data locked away in disparate data sources including personal drives, paper lab notebooks, networks and data warehouses. Organizations can now realize the cumulative benefit gained over the research life cycle with instant searchable access, analysis and insight to IP.

Compliance

Arxspan ELN is 21 CFR Part 11 compliant and offers optional SAFE-BioPharma support.

Efficiency

Arxspan easy-to-use interface works the way scientists work and reduces time consuming manual processes and streamlines workflow and information exchange.

Cost

Cloud-based deployment lowers the set up costs to organizations as well as reduces IT support and maintenance costs.

Flexibility

Deployment of the Arxspan software is flexible with cloud-based or on-premise options. The web based user environment is accessible from any device or operating system. Arxspan’s Notebook, Registration, and Inventory can be purchased as a suite or as stand alone modules.

Avoids Data Silos

Eliminate the data silos and manual processes in your organization and seek a faster, more cost effective way to capitalize R&D spend.

Whether the business is novel organometallic catalysts, combi-chem libraries, chiral building blocks for biomolecules, monomers for use in the plastics industry, petroleum additives or other myriad chemicals, new molecules are only useful if they can be registered, tracked, searched and directed toward new uses.

A molecule-centric platform that interprets structures accurately and securely is essential for an organization to develop the full value of its compounds. Scientists from the bench top to the pilot plant, from the preparation of new molecules in one laboratory through development by the entire organization require ease of experimental and data entry as well as experimental searchability and scalability to track milligrams to kilogram quantities. Arxspan electronic notebook, registration and inventory systems work seamlessly from a convenient web-interface.

Visibility

Secure uniform data storage eliminates problems caused by data locked away in disparate data sources including personal drives, paper lab notebooks, networks and data warehouses. Organizations can now realize the cumulative benefit gained over the research life cycle with instant searchable access, analysis and insight to IP.

Full Chemical Structure

An organization’s most valuable asset is the IP from its research, be it internal or out-sourced. Data standards, security and compliance with 21 CFR Part 11 are included in the software.

Flexibility

Low cost data migration from legacy systems is performed by the Arxspan team of professionals.

Bring Your Own Structure Drawing Tool

Deployment of the Arxspan software is flexible with cloud-based or on-premise options. The web based user environment is accessible from any device or operating system. Arxspan’s Notebook, Registration, and Inventory can be purchased as a suite or as stand alone modules.

Efficiency

Arxspan easy-to-use interface works the way scientists work and reduces time consuming manual processes and streamlines workflow and information exchange.

The Arxspan Notebook platform allows companies to manage all incoming contract research organization (CRO) work in real time: placing experimental result data into experiments, registering small molecule or biological compounds, registering assay data, or placing materials into inventory locations.

 Arxspan accommodates view only, write-only, or view-write CRO access to any client information in the system, with clients variably controlling information sharing capability among scientists within a CRO as well as across CRO organizations. CROs can sign off on work completed and internal managers can review and witness this work, as well as generate custom reports of some or all of the relevant data. Should a project or relationship end, CRO scientists can be instantly removed from either the relevant project or the Arxspan system completely, with legacy experimental data remaining intact and accessible by the client.

While ramping up relationships with CROs, scientific companies find that they are struggling with having informatics architecture and process that allow for optimal management of incoming CRO data.

Research data curation and exchange are bottlenecks, data quickly becomes decentralized and unsearchable, and integration with in house systems for bulk import of information is cumbersome. Receiving CRO data quickly and with higher quality and efficiency, as well as being able to effectively search and share it, are important factors in the CRO/Client partnership.

Arxspan’s cloud-based suite of applications can facilitate data transfer and collaboration between organizations, allowing for efficient sharing of results and reducing bottlenecks of knowledge transfer. Arxspan’s straight-forward, turn-key web-browser informatics solutions eliminate the IT pain of managing external CRO data.

Security

An organization’s most valuable asset is the IP from its research, be it internal or out-sourced. Data standards, security and compliance with 21 CFR Part 11 are included in the software.

Compliance

Arxspan easy-to-use interface works the way scientists work and reduces time consuming manual processes and streamlines workflow and information exchange.

Visibility

Low cost data migration from legacy systems is performed by the Arxspan team of professionals.

Efficiency

Deployment of the Arxspan software is flexible with cloud-based or on-premise options. The web based user environment is accessible from any device or operating system. Arxspan’s Notebook, Registration, and Inventory can be purchased as a suite or as stand alone modules.

Advantageous

Demonstrate a clear and competitive advantage while moving to a paperless internal environment with the Arxspan Notebook suite.

The petrochemical industry produces petrochemical, chemical, and petroleum materials to make products as diverse as fuel, solvents, detergents, adhesives, polymers, oligomers, resins, fibers, elastomers, lubricants, and gels.

Global petrochemical providers face many current challenges associated with their operations, including meeting growing demand, managing costs, adhering to environmental/health/safety regulations, achieving productivity and technology improvements, linking global research and technology operations, collaborating with partner organizations, and leveraging operational synergies from merger and acquisition activity. Many of these challenges are being met by improving R&D productivity as well as production efficiency.

To accomplish these goals, scientists working to research, produce, and refine existing and new molecules require a sharable and searchable repository for entering reaction data, registering new chemicals or assays, and managing inventory from bench top research to large scale production processes.

The Arxspan Notebook platform provides an intuitive and scalable electronic laboratory notebook for conducting chemical research and sharing results across a globally distributed scientific workforce — from laboratory to pilot plant to refinery.

The Arxspan Platform is cloud-based, allowing for scientists around the globe to share their scientific and technical data securely and in real time. External partners at collaborating companies or CROs can be added or subtracted from the system with a click of a button. Chemistry, organic chemistry, and polymer chemistry structures are recognized for synthesis, registration, inventory, tracking, and IP searchability through ChemDraw®, Accelrys Draw®, JChem®, or Marvin®. Arxspan’s easy to use interface works the way scientists work; it reduces the time consuming manual processes and streamlines workflow and information exchange. Duplicate recognition in the system eliminates costly repetition of chemistry. Experiments within Arxspan allow scientists to manage, search, and share information globally, and decision support tools allow for advanced sorting and analysis of all research data.

Speed scientific innovation and productivity in your organization and allow for faster product development timelines.

Manufacturing functions across all industries continually face pressure to streamline operations, reduce costs, and adequately meet all technical, legal, and regulatory requirements.

In order to accomplish these goals, manufacturers must ensure tight control over all sequences of tasks in the laboratory. Data storage and retrieval must be simplified, and information must be easily shareable across multiple functions and locations within an organization. Experiments and processes must have adequate audit trails and traceability to ensure intellectual property protection and adherence to regulatory requirements associated with manufacturing and related processes. Furthermore, monitoring of personnel workflows and review capability of experiments is important.

Requiring data entry into electronic laboratory notebooks from the very beginning of all processes ensures that all of these requirements can be met. ELNs document work product in a central format, create secure and real-time data access, allow for collaboration, ensure full audit trail of all processes, and allow for management to conveniently review work product.

Arxspan Notebook handles the strictest manufacturing requirements by offering an ELN that securely manages all research and process data while at the same time being flexible enough to adapt to new or changed processes. The system provides different types of experiments to manage chemical, biological, or engineering-related manufacturing as well as analytical characterization of manufactured compounds or components. Templates for repetitive procedures can be setup, facilitating process automation and elimination of manual errors. For chemical and biological manufacturing, Arxspan offers useful functionalities such as reaction tracking, automated compound checking for regulatory compliance, and an affiliated database for tracking manufacturing-related degradants and impurities.

The cloud-based aspect of Arxspan Notebook ensures effective, duplication-free collaboration across all internal technical groups as well as external groups such as CROs. Experimental notebooks can be shared with complete or restricted access to any group or individual, protocols can be copied from one operator to another, and process/quality test requests can be established.

All experimental protocols can be signed by operators and approved or rejected by managers overseeing operations. Arxspan Notebook features the SAFE BioPharma signature service for identity authentication associated with digital signatures in the pharmaceutical industry. Arxspan is GLP certified and 21 CFR Part 11 qualified.

The optional Arxspan Inventory module integrates with Arxspan Notebook and allows users to decrement inventory for use in procedures or experiments. Users can keep separate inventory stock for research, process development, manufacturing, and quality operations. Attachments such as MSDS and hazard, safety, and flammability reports can be stored in the system.

The optional Arxspan Assay module enables registration of assays and procedures for manufacturing as well as for process and formulation development. Users can register manufacturing trial settings and results, develop and document intellectual property associated with processes, and search and sort data for decision making.

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 Arxspan 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.

Scientists have full ELN functionality to record discovery research and preclinical safety and metabolism data within Arxspan 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. Arxspan Notebook has the capacity to store large data files, such as next generation sequencing data. The Arxspan 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. Arxspan 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.

The pace of academic research is accelerating, and the speed with which collaborations are struck between universities and governmental and non-governmental laboratories, as well as industry, continues to grow.

Academic researchers increasingly share their data for the purposes of publication, clinical trial initiation, and procuring funding for their work. The need for a system to adequately register their scientific experimental data as well as selectively and securely share it is growing. Furthermore, the amount of information that is being generating in biological research is massive and growing, increasing the need for robust systems to manage this scientific information.

Academic researchers have specialized requirements for an electronic laboratory notebook. They need a comprehensive resource that is able to store large amounts of data and attach files of any format. Their information needs to be organized and searchable by particular experiment or subject matter, not just chronologically. Their ELN needs to do be able to safely archive data for years to come and to have the capability to share data with anyone at any time

Principal investigators must be able to review their lab member's experimental progress and be able to easily produce reports of experiments for communication and publication. Academic researchers also often need access to a central system for storage of reagents and freezer contents, while at the same time having their notebooks kept private and confidential. Finally, the ELN needs to be intuitive, easy to use, and cost effective.

The Arxspan Notebook system is entirely cloud-based, with no servers or databases to purchase and install. Users of the system can be added or subtracted with the click of a button at any time. Furthermore, scientists can be allowed access to any notebook on the system with the click of a button, allowing flexibility of the size and dynamic of research teams associated with any given project. Also, the cloud-based nature of the system allows for secure and efficient collaboration between academia, government, NGOs, and industry. The Arxspan Inventory module can create a central location to track materials throughout the institute, as well as materials produced within a core facility.

Specialized workflows including animal and cell line management make it easy to document processes at the in vitro as well as in vivo stage.

Multiple devices are supported by Arxspan Notebook, allowing for free movement between office and laboratory. Instrument files can be attached to experiments, and copying and pasting functions are easy to use. Arxspan has an intuitive, attractive, and easy to use interface. PIs can monitor the work product of their entire lab in real time and can quickly generate comprehensive PDF versions of an entire experiment for the purposes of sharing or using as a basis for drafting a research paper. Data is protected in Arxspan’s secure data center, and all information is stored in a centralized repository rather than on shared or personal drives.

Improve basic scientific research speed, effectiveness, and productivity in your organization.