实验室数据管理系统 - Arxspan

行业概览

作为一个由科学家执笔编写的严谨软件,Arxspan 非常了解其所服务的市场的调性

Arxspan 软件套装

跨越多个行业和学科进行科学研究的组织都是为了提高研究生产力、提高协作能力和交叉交流,以及激励创新的需要。Arxspan了解化学、生物学、材料科学和其他科学学科正在进行的科学研究,并构建了Arxspan系统以满足众多科研部门的独特工作流程需求。

Arxspan Notebook 是一个全面的解决方案,可以用于管理从概念到商业化的科研及开发工作。Arxspan 可以为一系列需求提供全面支持,包括化学和生物实验工作流程、通过自由格式的研究笔记和搭载的附件输入数据、分析数据加载、可视化、搜索和决策支持,以及项目和工作请求管理等。Arxspan允许科研团队有效地管理科学内容和工作流程,并确保所有内部和外部利益相关者可以实时共享信息并交流。

Arxspan支持符合要求的签名和见证工作流程,包括多重身份验证(MFA),实验审核跟踪,知识产权发展跟踪,单点登录,选择性数据访问和共享以及其他功能,从而确保数据安全和科学团队之间的便利沟通,让组织能够记录其科研创新和发展的过程。

安全的数据管理,促进协作和外部化

制药

生命科学正在转型,药物发现模式也在改变。现在,许多发现项目都是由外部研究伙伴进行的。医药商业模式的这种快速变化,给共享和安全带来了巨大的数据挑战。安全灵活的数据管理系统可以实现合作伙伴网络各方面的协作、共享和创新。

今天,大多数研究实验室都在处理来自合作研究的海量数据,而且最常见的是来自CRO合作伙伴的数据。由于CRO设施在地理位置上的分离,硬拷贝数据输入几乎毫无用处。如果已经部署了电子笔记本应用程序,那么审查和手动输入由其他实验室笔记本应用程序提供的外部数据可能会很困难、耗时且容易出错。

Arxspan Notebook 的主要用途是安全地从CRO收集数据,并将这些数据无缝地批准和上传到制药公司现有的电子笔记本中。Arxspan 提供标准的集成,以实现这种类型的工作流程。

研究经理可以在将CRO 实验数据纳入他们现有的笔记本之前,查看、搜索和批准这些数据。如果出于安全考虑,可以选择在数据传输完成后删除Arxspan 提供的数据。

安全性

CRO用户对制药公司的IT基础设施没有可见性。这种安全性是通过使用Arxspan系统作为CRO笔记本系统而产生的,而不是通过改变现有企业笔记本系统的配置或权限而产生的,因为这将危及内部安全。

可见性

监测CRO研究,并以电子方式收集成果,包括电子签名和见证(如果需要)。

效率

CRO数据以电子方式推送到内部电子笔记本平台,省去了人工输入相关数据的时间和过程。

合规性

Arxspan笔记本符合21 CFR第11部分的规定,并提供可选的SAFE-生物制药支持。

高效数据管理,提高科研生产力

生物技术

助推创新生产力是研发成功的关键。在这个协作的时代,密集的环境和有效的数据管理是最重要的。

Arxspan 基于云计算的Arxspan ELN、Arxspan Registration、Arxspan Inventory 和Arxspan Assay 系统是一个以科研为中心的知识管理平台,通过确保数据的质量、一致性和安全访问,可以帮助企业在这个信息爆炸的时代实现数据的价值。其直截了当的交钥匙网络浏览器解决方案,消除了初创生物技术公司过去所忍受的 IT 问题。

Arxspan 实验室软件解决方案的一些优点如下:

安全性

一个组织最宝贵的资产是其研究的知识产权,无论是内部还是外包。软件中包含了数据标准、安全和符合21 CFR第11部分的规定。

数据完整性

低成本的数据迁移是由Arxspan的专业团队完成的。

可见性

安全统一的数据存储消除了数据被锁在不同数据源(包括个人驱动器、纸质实验室笔记本、网络和数据仓库)中造成的问题。现在,组织可以通过对知识产权的即时搜索访问、分析和洞察,实现在研究生命周期中获得的累积效益。

合规性

Arxspan ELN符合21 CFR第11部分的规定,并提供可选的SAFE生物制药支持。

效益

Arxspan易于使用的界面能让科学家的工作方式,减少耗费时间的人工流程,简化工作流程和信息交流。

成本

基于云计算的部署降低了企业的设置成本,同时也降低了IT支持和维护成本。

灵活性

Arxspan软件的部署非常灵活,可以选择基于云端或内部部署。基于网络的用户环境可以从任何设备或操作系统访问。Arxspan的笔记本、注册和库存可以作为一个套件或独立的模块购买。

避免数据孤岛

消除组织中的数据孤岛和手工流程,寻求一种更快、更有效的方式来实现研发支出的资本化。

推动新化学发展的解决方案

化学

无论业务是新型有机金属催化剂、组合化学库、生物分子的手性构件、塑料工业中使用的单体、石油添加剂或其他无数化学品,新分子只有在能够被注册、跟踪、搜索并导向新用途的情况下才有用。

一个以分子为中心的平台,能够准确、安全地解释结构,对于组织开发其化合物的全部价值至关重要。科学家们从工作台到中试工厂,从一个实验室的新分子制备到整个组织的开发,都需要方便的实验和数据输入,以及实验搜索性和可扩展性,以跟踪毫克到公斤的数量。Arxspan ELN,Registration 和Inventory 系统可以通过一个方便的网络界面进行无缝工作。

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.

Faster Results via Real-Time Sharing of Experimental Data

Contract Research

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.

Data Management Driving Improved Processes

Energy Effective

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.

Benefits for energy

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.

Streamlined Workflow Management Enabling more Efficient Processes

Manufacturing

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.

Benefits For Manufacturing

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.

Structured Data Collection and Management ensuring Compliance

Clinical Research

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.

Benefits For Clinical Research

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.

Collaborative System for Maintaining Project Continuity Amid Complexity

Academia

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.

Benefits For Academia

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.