Latest news with #EDC
Edinburgh Reporter
11 hours ago
- Health
- Edinburgh Reporter
Turning Data into Decisions The Power of Clinical Data Management in Modern Trials
Every clinical trial, no matter how complex or straightforward, generates data. From laboratory results and electronic case report forms to adverse event reports and patient-reported outcomes, the flow of data is constant and massive. Yet, raw data alone is not useful — it must be structured, validated, and transformed into reliable evidence that supports regulatory approval and, ultimately, clinical decisions. This is where clinical research data management services play an indispensable role. Why Is Data Management So Critical in Clinical Trials? In today's clinical environment, the speed and success of a study are increasingly determined by how efficiently data is handled. Sponsors, regulators, and investigators depend on high-quality, timely information to make protocol adjustments, conduct safety reviews, and prepare submissions. Poor data management can delay a trial, increase costs, or even invalidate results. Good data management ensures: Integrity of the study database Compliance with global regulatory standards Real-time monitoring of trial progress Faster insights for interim and final analyses Improved collaboration across teams Modern clinical trials cannot afford to treat data handling as an afterthought. It must be embedded from day one. What Do Data Management Services Typically Include? Clinical research data management services encompass a wide range of responsibilities, technologies, and workflows — all aimed at ensuring clean, accurate, and compliant data throughout the trial lifecycle. Some of the core components include: Case Report Form (CRF) design : Structuring questions and data fields for clarity and completeness : Structuring questions and data fields for clarity and completeness Electronic Data Capture (EDC) systems : Platforms for collecting and storing data securely : Platforms for collecting and storing data securely Query management : Identifying and resolving discrepancies or missing data : Identifying and resolving discrepancies or missing data Database validation and cleaning : Regular checks for consistency, outliers, or protocol deviations : Regular checks for consistency, outliers, or protocol deviations Data coding : Standardizing medical terms (e.g., MedDRA, WHO-DD) for analysis : Standardizing medical terms (e.g., MedDRA, WHO-DD) for analysis Data transfer and locking: Secure sharing of final datasets with statisticians and regulatory teams A well-functioning data management team works quietly behind the scenes, but their impact is felt throughout the trial — especially when problems are avoided or quickly resolved. EDC platforms (e.g., Medidata, Veeva, REDCap) Clinical Trial Management Systems (CTMS) ePRO and eCOA tools for patient input Risk-based monitoring dashboards Validation scripts and automated edit checks Image by Konstantin Kolosov from Pixabay Challenges and Solutions in Managing Trial Data Despite advances in technology, data management is not without its hurdles. Trials are becoming more decentralized, data sources are more diverse, and expectations for real-time insights are growing. Managing this complexity requires both technical skill and strategic thinking. Let's explore some common challenges and how experienced data managers address them: Decentralized data collection With patients submitting data via mobile apps, wearables, or home diagnostics, data managers must integrate and validate new input formats without compromising consistency. With patients submitting data via mobile apps, wearables, or home diagnostics, data managers must integrate and validate new input formats without compromising consistency. Protocol amendments mid-trial When protocols change, CRFs and data pipelines must be updated immediately — without jeopardizing data already collected. Agile EDC systems and flexible coding structures are essential. When protocols change, CRFs and data pipelines must be updated immediately — without jeopardizing data already collected. Agile EDC systems and flexible coding structures are essential. Cross-system integration Studies often involve multiple software platforms. Data teams must ensure smooth integration and unified reporting, especially when working with third-party labs or imaging providers. Studies often involve multiple software platforms. Data teams must ensure smooth integration and unified reporting, especially when working with third-party labs or imaging providers. Global data privacy compliance Regulations like GDPR and HIPAA mandate strict controls over patient information. Data managers ensure anonymization, encryption, and secure access at every stage. Regulations like GDPR and HIPAA mandate strict controls over patient information. Data managers ensure anonymization, encryption, and secure access at every stage. Fast database lock expectations Sponsors want results quickly. Data teams must balance speed with quality, preparing for interim analyses or regulatory submissions without rushing validation. Experienced providers of clinical research data management services anticipate these issues. Their processes are built to handle complexity, mitigate risks, and deliver results — often under significant time pressure. Why Outsourcing Data Management Makes Sense Many sponsors — especially smaller biotech or device companies — don't have in-house capacity to manage trial data effectively. Partnering with an external data management provider offers: Access to specialized expertise and tools Scalable support across multiple studies Greater consistency in data standards and coding Seamless integration with biostatistics and regulatory teams Cost-efficiency through centralized infrastructure However, choosing the right partner is essential. Sponsors should evaluate potential providers not only on technology, but also on experience with specific therapeutic areas, audit history, and adaptability to evolving trial designs. From Numbers to Knowledge Ultimately, the true value of data management lies in its ability to turn chaos into clarity. Clean, structured, and timely data enables more than just trial completion — it fuels insights, accelerates innovation, and drives better health outcomes. Whether through centralized databases, AI-assisted cleaning tools, or dedicated query resolution teams, modern clinical data handling has become a cornerstone of successful studies. In a world where speed, safety, and transparency are non-negotiable, data management is no longer a back-office function — it's a front-line driver of progress. Like this: Like Related
Techday NZ
20 hours ago
- Business
- Techday NZ
Pure Storage unveils Enterprise Data Cloud for unified control
Pure Storage has announced the availability of its Enterprise Data Cloud (EDC) platform, an approach designed to address the data management and storage requirements facing organisations today. The EDC aims to assist organisations in navigating growing volumes of data driven by artificial intelligence initiatives and shifting business demands, which often lead to fragmented storage systems and increased data sprawl. Rather than focusing solely on storage hardware, Pure Storage advocates for a model where organisations concentrate on understanding and managing their data estate irrespective of its location. Centralised control Within the EDC architecture, information technology teams can manage data centrally across on-premises, public cloud, and hybrid environments. The intention is to provide organisations with the flexibility to govern, access, and automate data management using a unified control plane. The Pure Storage platform is positioned as a means of implementing an EDC, enabling a single point of management and control over diverse data assets. The platform offers the ability to deliver data as a service, unifying disparate datasets and policies for streamlined operations. "It's time to stop managing storage and start managing data. With AI increasing the potential value of enterprise data, and cyber-threats imperilling it, data storage architectures and the tools for managing data have not kept pace. Only Pure Storage has innovated an architectural approach that enables enterprise customers to manage their global data estate. Pure Fusion allows customers to create their own global Enterprise Data Cloud empowering them to manage their data with the control, automation and tracking needed to lead in a data-driven world," said Charles Giancarlo, Chairman and CEO, Pure Storage. Central to the platform is Pure Fusion, which operates by unifying storage as a resource pool. This pool is adaptable, with arrays that support self-discovery, making it possible to expand the managed fleet of storage systems without detailed manual configuration. Every storage array is an access point, allowing fleet management from any endpoint. Feature upgrades The latest iteration of Pure Fusion introduces workload automation and new management presets for file, block, and object storage, supporting remote provisioning and reducing the necessity for administrators to undertake manual configuration or detailed pre-planning. These presets are intended to help lower the risk of non-compliance and improve resiliency by ensuring correct provisioning at the outset. Automation is extended across the platform to cover multiple functions, including provisioning and migration, with policy-driven orchestration and self-service capabilities implemented to reduce human error. Compliance and security features are embedded into the platform, aiming to increase cyber resilience and lower operational risk. The workflow orchestration system enables organisations to apply application or infrastructure automation by using existing connectors with third-party software such as Cisco, Microsoft, VMware, ServiceNow, and Slack. Administrators can run standard recipes or create bespoke automations that match their business processes. Security partnerships New integrations with Rubrik and CrowdStrike are expected to bolster cyber threat detection and recovery capabilities for customers. With Rubrik, Pure Fusion's new workflow orchestration integration allows for automated management and recovery following cyber incidents. If Rubrik Security Cloud detects an anomaly, Pure Fusion labels indelible SafeMode snapshots that Rubrik's ransomware scanning can identify as free from compromise. Should more precise recovery be required, Rubrik's backups are also available as a fallback. These tasks are managed through Pure1 Workflow Automation, aiming to reduce manual intervention and improve recovery times. Working with CrowdStrike, Pure Storage now offers an on-premises storage solution optimised for Falcon LogScale deployments. This new solution brings together Pure Storage's high-performance infrastructure with Falcon LogScale's log analytics for improved scalability, search, and security insights within environments that need to retain on-premises control. Disaster recovery and AI Copilot The Pure Protect system has expanded to support recovery from VMware to VMware, in addition to previous options like AWS and on-premises to cloud. The offering supports business continuity through flexible recovery workflows and assessment tools. The AI Copilot assistant is now available with capabilities to provide context-aware insights across various operational topics, such as security, performance, and sustainability, and is designed to operate continuously with updated contextual awareness of the managed storage and data fleet. Industry commentary Matt Kimball, Vice President & Principal Analyst, Moor Insights & Strategy, commented on the EDC approach: "Pure's Enterprise Data Cloud represents a tangible shift in how enterprises manage data and represents real change at the architectural level. By abstracting the complexity of hybrid environments into a unified, policy-driven platform, Pure is enabling organisations to bring clarity and control to data management at scale. With automation, intelligence, and simplicity built in, Pure is delivering on the vision of an enterprise data cloud in a way that's actionable today. It's a bold, thoughtful approach — and one that sets a new bar for the industry." Pure Storage asserts that its platform has been created to underpin the EDC model by combining infrastructure, intelligence, and integrated services to simplify data management for organisations dealing with increasingly complex requirements.
TECHx
a day ago
- Business
- TECHx
Pure Storage Unveils Enterprise Data Cloud Platform
Home » Emerging technologies » Storage » Pure Storage Unveils Enterprise Data Cloud Platform Pure Storage® (NYSE: PSTG), an IT company specializing in advanced data storage technology, has announced the launch of its Enterprise Data Cloud (EDC). This new platform introduces a bold architectural approach to simplify data and storage management. The company revealed that as AI accelerates data growth and business needs evolve, traditional storage methods are no longer efficient. These outdated models often result in silos, fragmentation, and data sprawl. Pure Storage stated that the EDC enables organizations to shift from managing storage infrastructure to managing data. This shift helps reduce risks, cut costs, and improve operational efficiency. According to the company, the EDC provides unified control over data across on-premises, public cloud, and hybrid environments. It allows IT teams to manage data as a single virtualized cloud with intelligent automation and governance. The EDC is delivered through the Pure Storage platform. This platform lets organizations unify data across their environments and manage it through a centralized control plane. The result is simplified, service-based data delivery. Charles Giancarlo, Chairman and CEO of Pure Storage, commented on the launch. He said, 'It's time to stop managing storage and start managing data.' He emphasized that only Pure Storage offers a solution that enables global data estate management at this scale. At the core of the platform is Pure Fusion™, which unifies storage as a pool of adaptable resources. Arrays are self-discoverable and manageable from any system. This eliminates the need for in-depth configuration. New features were also announced: Workload Automation: Pure Fusion now includes presets and remote provisioning for fleetwide file, block, and object. This improves resiliency and reduces compliance risk. Pure Fusion now includes presets and remote provisioning for fleetwide file, block, and object. This improves resiliency and reduces compliance risk. Workflow Orchestration: Admins can deploy workflows across storage, compute, network, and applications using thousands of third-party integrations. Security enhancements were also reported. The company introduced built-in compliance and cyber resilience features. These reduce risk by automating provisioning and data governance. Further partnerships were revealed to enhance the platform's security capabilities: Rubrik Integration: Rubrik Security Cloud works with Pure Fusion for automated threat response. It tags secure SafeMode snapshots for clean data recovery and reduces recovery time to near-zero. Rubrik Security Cloud works with Pure Fusion for automated threat response. It tags secure SafeMode snapshots for clean data recovery and reduces recovery time to near-zero. CrowdStrike Partnership: Pure Storage now supports Falcon LogScale in on-premises environments, providing high-performance log analytics and threat hunting capabilities. Additionally, Pure Protect™ now offers VMware-to-VMware recovery, along with existing recovery to AWS and on-prem environments. This helps customers maintain business continuity with flexible failover options. The company also reported that its AI Copilot is now generally available. This assistant provides personalized, fleet-aware insights across areas like performance, security, and sustainability. Matt Kimball, Vice President & Principal Analyst at Moor Insights & Strategy, shared his view. He said Pure Storage's EDC is 'a tangible shift' in enterprise data management, calling the approach 'bold' and 'actionable.' Pure Storage emphasized that the full potential of an Enterprise Data Cloud requires a platform built from the ground up. With this launch, it aims to combine infrastructure, intelligence, and integrated services into a unified experience.
Channel Post MEA
2 days ago
- Business
- Channel Post MEA
Pure Storage Enterprise Data Cloud Delivers Streamlined Data Management
Pure Storage has introduced the Enterprise Data Cloud (EDC), a new standard in data and storage management simplicity that enables organizations to focus on business outcomes, not infrastructure. Fueled by AI, data volumes are rising and business demands are evolving faster than ever. Traditional storage models create fragmentation, silos, and uncontrolled data sprawl. Organizations must adapt by shifting their mindset from managing storage to understanding how, where, and why their data is used. This will empower companies to reduce risks, costs, and operational inefficiencies. Solving the Problem of Data Management with an Enterprise Data Cloud An EDC is an industry-changing architectural approach to data storage and management. It gives organizations the ability to easily manage their data across their estate with unrivaled agility, efficiency and simplicity. With an EDC architecture, IT teams centrally manage a virtualized cloud of data with unified control — spanning on-premises, public cloud, and hybrid — enabling intelligent, autonomous data management and governance across the entire environment. Delivering the Enterprise Data Cloud with the Pure Storage Platform With an EDC architecture, organizations are better equipped to manage data at scale, reducing risk, and gaining increased control and insight across all environments. Redefining how data is delivered, governed, and consumed, the Pure Storage platform allows customers to build out their own EDC. The platform gives organizations the ability to unify data from across their estate into a virtualized cloud of data that is governed by an intelligent control plane for easy management, and delivered as a service. 'It's time to stop managing storage and start managing data. With AI increasing the potential value of enterprise data, and cyber-threats imperiling it, data storage architectures and the tools for managing data have not kept pace. Only Pure Storage has innovated an architectural approach that enables enterprise customers to manage their global data estate. Pure Fusion allows customers to create their own global Enterprise Data Cloud empowering them to manage their data with the control, automation and tracking needed to lead in a data-driven world,' said Charles Giancarlo, Chairman and CEO, Pure Storage . At the heart of this autonomous platform is Pure Fusion™, unifying storage as a pool of adaptable resources. Pure Fusion is natively built into the arrays, which are self-discoverable so they can automatically discover a broader fleet without requiring in-depth storage admin configuration. Administrators can manage the fleet from any system because every array is an endpoint. NEW: Pure Fusion with Workload Automation Pure Fusion now has presets and remote provisioning for fleetwide file, block and object. Admins have increased flexibility based on the specific needs of each workload and no longer need to pre-plan and tune deployments, which reduces risk of non-compliance and improves resiliency by ensuring that workloads are provisioned correctly from the beginning. Reducing the Risk of Human Error and Strengthening Security Today, enterprises struggle with increased risk, lack of compliance and inefficiencies resulting from manual operations around provisioning, migration and more. To eliminate these issues, automation spans the full stack of the platform with policy-driven orchestration and self-service capabilities. Built-in compliance and improved cyber resilience embedded across the platform further minimize risk through security and governance policies. These new capabilities completely redefine intelligent storage management. NEW: Workflow Orchestration The Pure Storage platform now delivers orchestrated workflows that can be deployed across the entire IT environment. Built on the thousands of existing connectors to third-party applications including Cisco, Microsoft, VMware, ServiceNow and Slack, presets and application 'recipes' can be easily deployed across storage, compute, network, database and application configurations. Customers will be able to run pre-set recipes or build custom ones specific for their environment, or utilize partner recipes for application to infrastructure automation. NEW: World Class Anomaly Threat Detection with Rubrik Security Cloud Rubrik is the first cyber recovery partner to integrate with Pure Fusion and its new workflow orchestration, streamlining cyber recovery across data environments. When Rubrik Security Cloud detects a threat, Pure Fusion automates the tagging of indelible SafeMode snapshots with Rubrik's ransomware scanning — pinpointing clean data for fast restore. For surgical or granular recovery needs, Rubrik backups provide a secondary path. Managed through Pure1 Workflow Automation, this integration reduces manual effort, improves compliance, and delivers near-zero RTO — so organizations can recover quickly and confidently with minimal disruption. NEW: CrowdStrike LogScale and Pure Storage Hunt Threats and Retain Logs CrowdStrike and Pure Storage have partnered to deliver the first validated on-premises storage solution specifically optimized for Falcon LogScale deployments. Combining Pure Storage's resilient, secure, high-performance storage infrastructure with Falcon LogScale's powerful log analytics, instant search, and security capabilities, organizations gain unmatched scalability and accelerated threat detection, hunting, investigation and response — while maintaining the control of on-premises, self-hosted environments. NEW: Pure Protect VMware to VMware Recovery Now offering recovery for VMware to VMware, in addition to recovery to AWS, on-premises to cloud, and self-service disaster recovery assessments, Pure Protect™ is designed for today's hybrid environments, streamlining recovery workflows with on-demand recovery and flexible failover options so customers can cost-effectively maintain business continuity. NEW: AI Copilot is now Generally Available The AI Copilot is an always-on assistant that delivers personalized, fleet-aware insights — with agents available for topics including security information, performance issues, digital commerce, sustainable operations, and support center. Matt Kimball, Vice President & Principal Analyst, Moor Insights & Strategy , noted, 'Pure's Enterprise Data Cloud represents a tangible shift in how enterprises manage data and represents real change at the architectural level. By abstracting the complexity of hybrid environments into a unified, policy-driven platform, Pure is enabling organizations to bring clarity and control to data management at scale. With automation, intelligence, and simplicity built in, Pure is delivering on the vision of an enterprise data cloud in a way that's actionable today. It's a bold, thoughtful approach — and one that sets a new bar for the industry.' The full benefits of an Enterprise Data Cloud require a platform created from the ground up to enable this model. Pure Storage brings together infrastructure, intelligence, and integrated services into one consistent experience.
Techday NZ
2 days ago
- Business
- Techday NZ
Pure Storage unveils Enterprise Data Cloud & flash upgrades
Pure Storage has announced the launch of its Enterprise Data Cloud platform and a series of flash hardware updates designed to address the demands of modern data management and high-performance workloads. Enterprise Data Cloud platform The newly introduced Enterprise Data Cloud (EDC) aims to simplify data and storage management for organisations, enabling a focus on business outcomes rather than infrastructure concerns. The platform, delivered by Pure Storage, facilitates centralised management of data across on-premises, public cloud, and hybrid environments through a unified control plane. According to the company, the EDC model is intended to combat the fragmentation and inefficiencies often associated with traditional storage solutions, which can result in silos and uncontrolled data sprawl. Pure Storage claims that their approach provides IT teams with agile, efficient, and simplified data governance on a broad scale. Charles Giancarlo, Chairman and Chief Executive Officer, Pure Storage, said: "It's time to stop managing storage and start managing data. With AI increasing the potential value of enterprise data, and cyber-threats imperiling it, data storage architectures and the tools for managing data have not kept pace. Only Pure Storage has innovated an architectural approach that enables enterprise customers to manage their global data estate. Pure Fusion allows customers to create their own global Enterprise Data Cloud empowering them to manage their data with the control, automation and tracking needed to lead in a data-driven world." At the core of the EDC is Pure Fusion, a capability which virtualises storage resources and provides autonomous management. Pure Fusion is embedded within storage arrays, allowing for self-discovery and centralised management across an array fleet, minimising the need for manual configuration. Automation and security enhancements The introduction also brings expanded automation options to Pure Fusion, including workload-aware provisioning of file, block, and object storage across the fleet, and automated workflow orchestration. These features are intended to minimise manual operations, reduce non-compliance risks, and improve application resilience. Workflow orchestration now leverages existing integrations with a range of third-party applications such as Cisco, Microsoft, VMware, ServiceNow, and Slack. Users can deploy pre-defined or custom workflows to automate storage, compute, network, database, and application configuration processes. Security is further strengthened through integrations with partners like Rubrik and CrowdStrike. Rubrik Security Cloud is now integrated with Pure Fusion, enabling automated tagging of backup snapshots and improved cyber recovery in response to detected threats. CrowdStrike's Falcon LogScale, combined with Pure Storage infrastructure, aims to provide high-performance, on-premises log analytics and threat detection. Additional enhancements include new disaster recovery options for VMware workloads via Pure Protect and the general availability of an AI Copilot that provides fleet-level insights across topics such as security, performance, and sustainability. Matt Kimball, Vice President and Principal Analyst at Moor Insights & Strategy, observed, "Pure's Enterprise Data Cloud represents a tangible shift in how enterprises manage data and represents real change at the architectural level. By abstracting the complexity of hybrid environments into a unified, policy-driven platform, Pure is enabling organizations to bring clarity and control to data management at scale. With automation, intelligence, and simplicity built in, Pure is delivering on the vision of an enterprise data cloud in a way that's actionable today. It's a bold, thoughtful approach — and one that sets a new bar for the industry." Flash hardware updates In a parallel announcement, Pure Storage detailed upgrades to its FlashArray and FlashBlade product lines to support performance at larger scales and new storage workloads. The new FlashArray//XL R5 is designed to double Input/Output Operations Per Second (IOPS) per rack unit and increase maximum raw capacity by 50% compared to previous models. Steven Allgeier, Vice President, Distributed Infrastructure Group at Fiserv, commented, "At Fiserv we recognize our customers' urgent need to manage escalating data demands with greater efficiency. With Pure Storage FlashArray, we are able to continuously deliver an optimal all-flash performance with reliability for most mission-critical workloads. We are excited to see the benefits of the next-gen FlashArray//XL R5 and how they will empower our customers to scale for extreme demands." The FlashArray//ST supports latency-sensitive workloads, delivering more than 10 million IOPS per five rack units. Meanwhile, the upgraded FlashBlade//S features controller blades that Pure Storage claims boost performance by up to 30% over competitors in tasks like genome sequencing and AI-driven analysis. Pure Storage has also consolidated its approach to unstructured data by extending object support to FlashArray, allowing block, file, and object management within a single platform. John Colgrove, Founder and Chief Visionary at Pure Storage, said, "In an era where data is king and IT complexity remains a major hurdle to accessing and using data for optimal business value, Pure Storage is once again redefining what's possible for customers. Pure Storage delivers the magic by rejecting the norms we've come to accept for storage infrastructure; they are what's holding us back within this new era of exponential data growth and logarithmic growth of insight value." He added, "Pure Storage was born to disrupt the industry, as we introduced new capabilities to reliably achieve better and better performance at any scale. We are unwavering in our mission to enable our customers' ambitions, providing the most innovative and reliable foundation they need to confidently meet any future challenge or opportunity."
