Ensuring Scientific Reproducibility with a Sustainable FAIR Data Platform

Authored by 20/15 Visioneers

Background

ZONTAL (zontal.io) is a scientific software company pioneering FAIR (Findable, Accessible, Interoperable, Reusable) data and seamless services to the life science industry, aiming to revolutionize software through innovative, efficient, and sustainable digital advancements. Their flexible product versatility to both biopharma and biotech serves as a FAIR scientific data management and collaboration platform, meticulously crafted to streamline, and automate organizational processes, fortify data integrity, and guarantee adherence to regulatory standards.

A FAIR scientific data management platform ensures that data is organized so that it is easily discovered, accessed, understood, and utilized for diverse purposes, employing ontology standardized metadata, facilitating seamless integration across systems, and providing tools for data curation and annotation.

Lastly, the newer or broader world of AI is solely dependent on this enhanced or model-quality data to drive insights and higher order efficiencies.

ZONTAL History

Founded in 2016 with headquarters in Provo Utah, ZONTAL was established by a group of forward thinking software engineers driven by a passion for utilizing technology to transform the life sciences sector. Initially, the company focused on crafting tailored, sustainable electronic software solutions for research institutions and biotech firms. Over time, they honed proficiency in scientific data management and collaboration, culminating in the introduction of their groundbreaking premium product, ZONTAL Space. This innovative platform was meticulously engineered to streamline operations and uphold data integrity within the life sciences industry.

Reasons for ZONTAL Growth

ZONTAL is primed for substantial growth due to its strategic planning and applicability in Life Sciences now and in the future. Firstly, the burgeoning demand for streamlined digital solutions (FAIR efficiency and AI) within the life sciences industry creates fertile ground for ZONTAL's expansion. Secondly, their unwavering commitment to innovation and sustainability positions them as a leader in an ever-evolving technological realm, attracting both clients and investors. Moreover, the company’s track record of delivering cutting-edge scientific data management and collaboration platforms to key Biopharma partners, exemplified by their versatile frameworks, reinforces their standing as a trusted ally for organizations aiming to enhance their operations. Lastly, ZONTAL's strategic emphasis on spearheading digital transformation in Research and Development (R&D) and quality management sectors perfectly aligns with prevailing industry trends, propelling their growth trajectory.

The Journey of ZONTAL Solutions

Common scientific and laboratory data management issues include siloed applications (ELN, LIMS, CDS, SDMS etc.), multiple data formats, manual data transfer, and a lack of overall visibility from data collection to final analysis. This can usually be attributed to poor data culture and the lack of a scientific data strategy. ZONTAL tackles data aggregation, transformation, analysis, and preservation challenges headon. By adopting the Allotrope data framework, a widely recognized and increasingly adopted framework in the pharmaceutical and analytical laboratory sectors, ZONTAL enhanced its user-friendly scientific data management platform. This integration simplifies data handling, ensures high standards of data integrity, and supports a diverse product lineup, including Digital Lab, Data Preservation, and Life Science Analytics. This product suite, is complemented by specialized modules such as Applications Hub, Data Hub, Image Hub, Methods Hub, and Operations Hub, providing an all-in-one system for managing lab data and automating workflows to meet various customer needs. They ensure efficient data handling, consistent and repeatable experiments, and optimized lab operations for top performance and compliance. Their platform supports a wide range of applications, including data produced from analytical laboratory Instruments such as DVS, Flow Cytometry, Mass Spectrometry, NMR Spectroscopy, Plate Reader, Thermal Analysis, and X-Ray Diffraction. It facilitates experiment planning and execution through ELN, LIMS, and other laboratory informatics tools. Additionally, the platform enables data automation, visualization for analysis, and comprehensive data archiving. ZONTAL is committed to delivering sustainable and reproducible solutions for Discovery Biology, Synthetic Chemistry, ELN, and LIMS. This holistic suite solidifies their pioneering position in innovation and industry progress. The Digital Lab facilitates virtual experimentation, workflow management, and online collaboration by integrating ELNs, LIMS, data analysis, and instrument control interfaces. Data Preservation optimizes lab operations, archives data, and ensures its safety and accessibility. Meanwhile, Life Science Analytics simplifies data handling, enabling a seamless transition from data to insights (see Figure 1).

Bringing Value to a Multitude of Personas

The company promotes digital sustainability in R&D scientific and laboratory informatics and data, catering to a diverse range of personas within the life sciences industry. Their solutions are meticulously designed to meet the specialized needs of professionals across various domains within biopharma, including supporting scientists in research, assisting lab technicians with data analysis, enabling administrators to streamline operations, empowering IT professionals with robust technological infrastructure, facilitating efficient management for lab managers, providing engineering solutions for specialized tasks, and aiding research associates in project execution. These tailored solutions contribute to overall operational excellence, fostering innovation and productivity in their respective fields. The company’s offerings address the needs of three primary customer segments encompassing the abovementioned personas:

• Biotech/Biopharmaceutical Research: Focuses on facilitating collaboration and scientific data management in research projects.

• Biopharmaceutical Development: Involves optimizing drug development (CMC), managing clinical trial data, and ensuring regulatory compliance.

• Quality Control (QC): Aims to enhance the efficiency and accuracy of manufacturing processes.

Pertinent Use Cases

Several companies, including AstraZeneca, Novartis, and many others, have integrated the platform to enhance efficiency and improve data curation. A typical lab experiment goes through planning, setup, execution, analysis, and archiving stages, involving systems like ERP for procurement, Maximo for equipment maintenance, inventory systems, result capture systems, and data analysis systems. Each step can use different data storage methods, metadata formats, and search tagging. A significant advantage of using ZONTAL in Discovery Biology is its ability to automate laboratory processes, ensure GxP (Good Manufacturing/Laboratory/Clinical Practice) compliance and employ FAIR scientific data management principles. It efficiently handles experimental planning and manages the vast datasets generated by next-generation sequencing (NGS), which pose challenges for storage, transfer, and analysis. ZONTAL integrates sequencing requests and triggers cloud-based analysis, streamlining the entire process.

Starting with experiment planning in an Electronic Lab Notebook (ELN), which includes comprehensive experiment metadata (such as Sample IDs/experiment/assay types/equipment IDs/Methods etc.), customers can reference entries in a materials/inventory library and initiate an experiment request in ZONTAL that covers multiple tests. Subsequently, requests for sample characterization and QC tests in LIMS (Sample IDs/Experiment IDs/assay types/equipment IDs/Method IDs/Results etc.), including cell counting and RNA purity analysis, are initiated, and the captured results and reports are automatically transitioned back into the ELN, consistently documenting even small measurements. Additionally, all data undergoes vendor-neutral processing during ingestion and is annotated according to a customer-defined ontology. The Allotrope Foundation ontologies (AFO) act as the default standard, which can be easily tailored for numerous biology applications according to customer needs.

After scientists decide the cells are ready for the next step, they initiate the sequencing requests which is triggering ZONTAL to collect all necessary information from the planning phase and compile a data package including sample information and library prep protocols making sure the sample to library step is captured in the platform and linked to the process. Upon completion of the sequencing run, ZONTAL retrieves all local sequencing output files, preserving them in Amazon S3 buckets, and automatically triggers a cloud-based conversion and analysis pipelines to utilize the files without requiring additional upload or storage. Subsequently, the relevant genes identified by the analysis pipeline are subsequently annotated using experiment identifiers or metadata to establish full lineage, after which the conclusions, including experiment identifier, sample name, and gene name details, are exported back into the ELN, and scientists are promptly notified in the channel of their choice ranging from Email to Teams to Slack.

Moreover, ELN archiving within ZONTAL securely ensures this entire process, ensuring all experiment data from planning to result, is preserved in a compliant and easily accessible manner (see Figure 2). This archiving process supports long-term data integrity and accessibility facilitating seamless retrieval of historical data for future research. By maintaining a consistent and traceable record of all laboratory activities and results, ZONTAL helps laboratories adhere to the regulatory requirements allowing researchers to easily access and review past experiments ensuring transparency and reproducibility. This capability can be easily integrated with other data management systems, enabling interoperability and data exchange across different platforms accelerating scientific discovery and innovation.

This multi-step workflow involves various file formats, requiring standardized input and output throughout the process, enabling smooth communication between on-premise and cloud to cloud systems, thereby minimizing manual data administration and ensuring an optimal, sustainable, and reproducible laboratory workflow for end-users.

CMC Use Case

A use case in Pharma development is the support of Chemistry, Manufacturing, and Controls (CMC) practices by ZONTAL since data analysis is integral to modern CMC. In CMC, data flows from raw material sample collection and preparation, through experimentation and analysis, to data interpretation, manufacturing, and quality control. However, this data is often siloed across departments like analytical lab, supply chain, manufacturing, Regulatory Affairs, and QA/QC. Data from transactional systems like ELN, LIMS and SAP could be connected automatically by ZONTAL forming a FAIR data layer on top of these transactional systems. The platform also links the data models directly to Ontologies, which are maintained outside of ZONTAL.

A key component in the manufacturing process is utilizing Stability Reports to ensure that batch records maintain their quality, safety, and efficacy throughout their shelf life. ZONTAL enables the creation of interactive Stability Reports in weeks instead of months. This allows users to query multiple batch records, analyze degradation data over time, and use machine learning for outlier detection and prediction.

Building a use case like these on top of an existing ZONTAL FAIR data platform is easily done by anyone not even familiar with the underlying data sources. At the beginning of such a project the business and the use case team would be using the Ontology and tools to link data from the harmonized data model across different data systems.

United States Pharmacopeia (USP): Another example of digitalization in the Life Sciences industry occurred when ZONTAL partnered with the United States Pharmacopeia (USP) to digitalize monographs using Natural Language Processing (NLP) technologies (see Figure 3). Monographs, which provide detailed descriptions of drug substances and products, are critical for ensuring quality and consistency in pharmaceuticals. However, their traditional manual management can be time-consuming and prone to errors. By leveraging NLP, ZONTAL and USP aimed to automate the extraction and structuring of information from these monographs, ensuring more consistent and reliable scientific data management. This initiative not only improved the accuracy of the monographs but also significantly streamlined the entire process.

The collaboration optimized digital workflows in several key areas. It facilitated the digitalization of monographs, converting them from paper or static digital formats into dynamic, searchable, and analyzable digital formats. It also enabled the transfer of analytical methods directly to Chromatography Data Systems (CDS), allowing laboratories to seamlessly adopt new methods and ensure they were applied correctly and consistently. Additionally, the integration with ZONTAL's platform allowed for the seamless execution of sample analyses, with data automatically captured and managed within the system. This resulted in more efficient data retrieval, review, and reporting, demonstrating how advanced digital technologies like NLP can enhance the accuracy, efficiency, and reliability of critical processes in the Life Sciences industry.

Value

ZONTAL provides value by offering cutting-edge, digitally sustainable solutions tailored to the unique needs of the life sciences industry. The company’s product suite streamlines processes, aiding customers in achieving their objectives:

• Enhanced Efficiency: Automation of routine tasks and reduction of manual data handling. • Improved Collaboration: Heightened communication and collaboration among teams.

• Regulatory Compliance: Assistance in meeting rigorous regulatory standards.

• Data Security: Protection of sensitive data through advanced security features.

• Data Preservation: All data in a vendor neutral format for long term FAIR storage.

Why ZONTAL

If you are looking for tailored, innovative automatic solutions that prioritize compliance and collaboration, empowering your organization to thrive in the dynamic landscape of the life sciences industry, then ZONTAL is the best choice. With a focus on digitized sustainability in research, the platform ensures data security and streamlines processes for maximum efficiency, driven by innovation and expertise. Some of the key features are:

• Scientific Data Management: Centralized repository for storing and managing scientific data and documents. Support for various data formats, including images, documents, and structured data.

• Collaboration: Custom tools to facilitate collaboration among researchers and teams. Secure sharing of data and insights within the organization.

• Compliance: Ensures compliance with industry regulations such as FDA, ISO, GxP. Comprehensive audit trials and electronic signatures.

• Integration: Integrates with existing laboratory systems and instruments. Supports seamless data exchange between different platforms.

• Data Integrity: Maintains data integrity through robust security measures. Version control and traceability of changes.

• Analytics: Advanced cloud-based analytics tools for data analysis and visualization. Helps in extracting actionable insights from complex datasets eliminating data wrangling.

ZONTAL has referenceable large biopharma clients today getting high value from their software and services. They have the deep experience you are looking for, so if you are seeking sustainable digital R&D solutions that can be integrated into a FAIR scientific data management platform, ZONTAL can meet your needs. Please contact them at support@zontal.io or call us at:

US: +1 (385) 375-2389

Germany: +49 (151) 1143-5327