Digital CMC Summit 2025
Zifo is a proud Sponsor of Digital CMC Summit 2025!
Join us on February 25-27, 2025 for QbDVision’s user conference, where you’ll have the opportunity to hear from industry leaders, connect with peers.
Link to Event Page
Zifo
Digital CMC Summit 2025
Zifo is a proud Sponsor of Digital CMC Summit 2025!
Join us on February 25-27, 2025 for QbDVision’s user conference, where you’ll have the opportunity to hear from industry leaders, connect with peers.
Link to Event Page
Comprehensive Clinical Trial Solutions
Zifo programs complex randomization and IP logistics, ensuring smooth site data entry across diverse therapeutic areas, including oncology, neurology, immunology, cardiology, and more. Our expertise extends to medical devices, dental implants, and vaccine studies.
We excel in drug supply management, IRT integrations, and detailed data mapping. With extensive regulatory experience (FDA, PMDA, EMA, HC), including BIMO and ARM/ARS packages, we support global submissions. Our statistical services cover the entire trial lifecycle, from CRF review and protocol development to DSMB/DSUR support and adaptive trial design. We automate summaries, perform QC with SeeWise, and manage deviations. De-identification expertise (Safe Harbor, expert determination) protects participant privacy.
Automation
Thousands of clinical trials occur across the globe every year, each with its own set of needs and specific data management requirements. Zifo provides risk-based data management, seamlessly integrating with various EDCs (Medidata Rave, Marvin, Viedoc4, and more), including rescue studies and post-go-live amendments. Our real-time safety reporting automates adverse event and protocol deviation reporting, ensuring regulatory compliance (ICH E2B).
With 15 years of SAS expertise, we create SDTM/ADaM datasets and TLGs, leveraging 100+ macros and an automapper tool. Zifo also pioneers R programming and JSON datasets for cutting-edge statistical analysis. We ensure data quality across multiple sources, eliminating duplicates and irrelevant information. Our expertise extends to decentralized trials, offering innovative approaches and solutions for this evolving landscape.
Artificial Intelligence (AI)
We are enhancing medical writing with generative AI to quickly create standard study report sections, including safety assessments. Our medical coding tools (eXt, mXt) automate processes for accuracy and efficiency, specializing in ATC coding for better drug classification. A cutting-edge bot automates SDTM package and annotated CRF (aCRF) creation, streamlining clinical data management and ensuring compliance. Our team creates high-quality submission packages (CRT, SDRG, ADRG) using in-house tools, ensuring compliance, accuracy, and timely delivery for successful regulatory submissions.
Change Management and User Adoption
Key components of Zifo’s change management service include assessing the impact of change, engaging stakeholders early, identifying change champions, designing user-friendly training programs, and ensuring proactive communication. This also encompasses user adoption and training, focusing on user-centric design, planning phased rollouts, motivating early adopters, providing comprehensive onboarding support, and using data, such as adoption rates, to refine the approach for maximum success.
Post Implementation Operations and Governance
Key components of Zifo’s Operations and Governance services include performance monitoring, continuously tracking the performance of implemented systems, platforms, or processes against defined KPIs; user support and issue resolution, providing ongoing technical support to R&D end-users, including troubleshooting and system updates; bug fixes and updates, identifying and resolving post-deployment issues and ensuring software remains current; data quality management, maintaining high standards of data quality, integrity, and accuracy; scaling and expansion, smoothly handling system expansions as R&D projects grow; and governance policies and procedures, establishing clear guidelines for post-implementation system management, including decision-making, issue escalation, and continuous operational monitoring and improvement.
Integrated Laboratory
Scientists often spend a significant amount of time navigating multiple systems (both hardware and software) to document their research data and derive meaningful insights. Life sciences leadership is increasingly focused on establishing integrated labs—connecting laboratory instruments, software systems, and data management platforms—to reduce this burden. Key components of an integrated lab include equipment integration, connecting instruments like spectrometers, chromatographs, and microscopes to centralized systems for data exchange, and informatics integration, linking lab management systems (e.g., LIMS) with these instruments to streamline data collection, analysis, and reporting.
Data Management and Migration
Zifo’s Data Management experts can help you assess the complexity of diverse data types, analyze data structures within legacy systems, and address challenges related to data volume and access control. We provide end-to-end support in developing and executing effective data migration and management strategies. Key elements of our solutions include retaining structure data models, centralized data repositories, automated migration, data backup and redundancy, and robust metadata management.
Scientific Workflow Design and Development
Zifo’s informatics consultants can help with the end-to-end design and development of various workflows. This includes creating predefined templates for different types of experiments, organizational protocols, and regulatory guidelines. Zifo can also configure informatics platforms to automate data entry, capturing data from connected lab instruments, sensors, or external databases, or even scanning barcodes or QR codes for sample tracking.
Furthermore, Zifo can set up review workflows that ensure data is reviewed and validated by the appropriate personnel, whether peer or lab manager. They can also implement alerts and notifications, setting up automatic reminders for key steps or incomplete data. Finally, Zifo can establish workflows that allow for visualization modules to generate insightful graphs and charts for reporting and data analysis.
Business Process Mapping
Key outcomes of Zifo’s BPM exercise include process optimization, identifying inefficiencies, reducing waste, and improving time management. Zifo also identifies repetitive manual tasks suitable for automation to enhance efficiency and streamline operations. Furthermore, the BPM exercise helps onboard new employees by providing clear visual representations of key processes.
Software and Application Development
We empower scientists to focus on what they do best — analysis and decision-making — by eliminating the need to navigate complex coding or engineering challenges. Our expertise lies in supporting scientific teams handling multimodal data (such as omics, assays, clinical, population studies, consortium, imaging, etc.). Whether it is creating tailored dashboards, deploying agile RShiny applications, or building organization-wide scientific platforms, we deliver intuitive solutions that enable impactful discoveries.
Data Solutions
Gaining insights from scientific data demands both domain expertise and technical proficiency. Our team bridges the gap by combining deep scientific knowledge with advanced engineering skills to deliver bespoke solutions. Whether it’s mining public datasets for actionable knowledge, building knowledge graphs for specific use cases, or structuring metadata for data lake initiatives or semantic integration, we provide the expertise to support your research and innovation goals, ensuring we follow the FAIR principles (Findable, Accessible, Interoperable, Reusable) and are conscious of data maturity and readiness.
Scientific Workflows and Omics Pipeline Engineering
Leveraging our bioinformatics engineering and research infrastructure expertise, clients engage with us to build custom omics workflows, transitioning pipelines from legacy systems to Nextflow for enhanced efficiency, and reducing costs by selecting optimal resources. Additionally, we can develop new pipelines and applications within your existing commercial or enterprise systems, ensuring seamless integration and improved performance.
Analysis and Insight Generation
When companies partner with us, our mission is to transform their diverse data — whether internal or sourced externally (CRO or public datasets) — into actionable insights. Collaborating closely with scientists, we address key research questions and contribute to strategic goals such as target evaluation, indication prioritization and expansion, understanding drug mechanisms of action, pathway analysis, and biomarker identification to enhance patient selection and enrichment.
