Safety & Pharmacovigilance

Improve patient safety, optimize global compliance, and make better decisions faster.

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Safety & Pharmacovigilance

Cloudbyz Safety and Pharmacovigilance (PV) database is a cloud-based solution built natively on the Salesforce platform, offering 360 degree view across R&D and commercial. It enables pharma, bio-tech and medical device companies to make faster and better safety decisions by optimizing global pharmacovigilance compliance along with easy to integrate regulatory compliance features.

Our pharmacovigilance database solution easily integrates the required data over a centralized cloud-based platform for advanced analytics set-up along with data integrity. It empowers the end-user with proactive pharmacovigilance, smart features with data-backed predictability, scalability, and cost-effective support.

Welcome to Cloudbyz, your trusted partner for intelligent and comprehensive Pharmacovigilance solutions. Our platform ensures enhanced patient safety and streamlined drug surveillance operations.

About Cloudbyz Pharmacovigilance Solution

Cloudbyz recognizes the integral role of pharmacovigilance in maintaining drug safety and regulatory compliance in the healthcare industry. We've designed a cutting-edge solution that tackles the unique challenges of this domain, simplifying processes, enhancing efficiency, and offering reliable, actionable insights.

Our pharmacovigilance solution, built natively on the Salesforce platform, allows for proficient collection, analysis, monitoring, and prevention of adverse drug effects. It unifies data from numerous sources, creating a comprehensive hub for managing all your drug safety needs.

Key Features

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Automated Case Intake

Cloudbyz Safety and Pharmacovigilance solution automates the intake of cases received from various sources and formats (ICH E2B R3/R2) by utilizing cutting-edge technologies. This entire process leads to significant increase in case management efficiency, scalability and enhanced accuracy. Additionally during submission of regulatory reports, users can filter out cases for review, which require submission according to the regulatory timeline.

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Configurable Case Workflow Automation

Simplify your case processing with our configurable automated workflows, which standardize tasks from intake to follow-up. This not only enhances efficiency but also reduces the likelihood of manual errors, allowing your team to focus on other critical tasks.

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WHO DD/ MedDRA Medical Coding

Leveraging WHODrug and MedDRA dictionary integrations, the Cloudbyz system can enable coding of adverse events, medical histories, laboratory tests, medications, and more as per industry standards. The WHODrug dictionary can be integrated via APIs with the Cloudbyz solution thereby removing any need for upload of the complete dictionary in the system and versioning with every release. Users can version the MedDRA according to each account, project, or clinical study. Additionally, users can select the dictionary type for coding, which can be either library-based or API-based.

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Submission Preview

Allows users to preview all of the cases in the desired regulatory report at once. The preview can be viewed and exported in either draft or final form for the report submission process.

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Case Extraction from Unstructured Documents (CIOMS)

Leverage advanced AI technology to extract crucial case details from unstructured CIOMS documents, streamlining data extraction and reducing manual effort. This capability promotes data accuracy and speeds up the data extraction process.

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Template-Based Automatic Narratives

Our solution enables the generation of detailed case narratives using predefined templates. This feature not only saves time but also ensures uniformity across all case reports, facilitating easier analysis and comprehension.

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Medical Review and Approval Automation

Streamline your medical review and approval processes with automated workflows and alerts. This promotes swift, accurate reviews and accelerates the approval process, ensuring timely action on critical adverse events.

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AI/ML Data Extraction & Redaction

Our solution comes with AI/ML based data redaction and extraction from unstructured documents.

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Regulatory Submission E2B Gateway

With our solution, you can seamlessly submit reports to global health authorities in the required E2B R2, E2B R3, MDCG, and MedWatch 3500A formats. This facilitates smooth regulatory interactions and ensures compliance with international pharmacovigilance standards.

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Aggregate Reporting

We help in processing the cumulative safety data from a wide range of sources on a periodic basis and help in regulatory submissions of various reports like PSUR, PADER, PBRER, DSUR, and Ad-hoc reports. Our system is capable of generating case line listings at MedDRA level for individual products with auto generated templates designed as per client SOP.

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Risk Management

Proactively assess and manage potential risks associated with your products using our advanced risk management tools. This feature allows you to act swiftly on identified risks, enhancing patient safety and reducing potential harm.

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Unified with Cloudbyz Clinical Trials Management

Our solution can seamlessly integrate with Cloudbyz clinical trial management solutions including CTMS, eTMF and EDC solutions built on the Salesforce platform making it a unified platform supporting end-to-end clinical and post market processes.

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Integration Capabilities

Our solution can seamlessly integrate with external databases and systems, ensuring efficient data exchange and a unified view of your drug safety data. This facilitates more informed decision-making and enhances the efficiency of your operations.

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Signal Management

Our system assists medical experts in making decisions, saving you valuable time and requiring less effort to go through each and every case for signal detection. Our signal management system helps in signal detection using well defined statistical approaches with a set Signal Disproportionate Report threshold, signal validation using predefined customizable algorithms for case by case analysis, and signal prioritization based on defined criteria to help the clients with signal assessment. We also help in FAERS andÂ EVDAS reviews for products by monitoring SDR and ROR as defined. With Litbyz, we also help in gathering additional supportive data for signal assessment.

Benefits

By opting for Cloudbyz's Pharmacovigilance solution, you stand to gain:

Streamlined Operations

Centralizing and automating your drug safety operations improves efficiency and reduces the likelihood of manual errors. By automating repetitive tasks, you can free up your team's time to focus on more critical operations, boosting productivity.

Regulatory Compliance

Our solution ensures adherence to global pharmacovigilance regulations with its automated reporting capabilities and standardized coding. This promotes smooth interactions with regulatory bodies and reduces the risk of non-compliance penalties, thus safeguarding your organization's reputation.

Accurate Data

With Cloudbyz, you can access reliable, real-time data for making informed safety decisions. The solution promotes data integrity and consistency, allowing for accurate assessments and enabling you to respond proactively to potential safety issues.

Early Detection

Leverage our solution's advanced signal detection capabilities to identify potential safety issues early. This proactive approach can lead to prompt action, reducing the potential impact of adverse events and enhancing patient safety.

Enhanced Patient Safety

Our solution effectively manages and mitigates drug-related risks, ultimately enhancing patient safety. By efficiently tracking and responding to adverse events, you can ensure the safety and satisfaction of your patients, promoting trust in your organization.

Better Resource Allocation

The automation and streamlining of operations allow for better resource allocation. By freeing up your staff's time from manual, repetitive tasks, they can focus on more strategic, value-added tasks.

Quick Response to Market Changes

Our solution's real-time data access and analysis features enable you to swiftly adapt to changes in the market. This promotes agility and ensures your operations stay relevant and effective in a rapidly evolving industry.

Scalability

Cloudbyz's Pharmacovigilance solution is designed to grow with your organization. As your needs evolve, our solution can scale to match your growing operations, ensuring continuous, seamless support for your drug safety management.

Data-Driven Decisions

The robust reporting and analysis capabilities of our solution enable you to make data-driven decisions. This leads to more accurate and impactful decisions, driving operational excellence and strategic growth.

Cost Efficiency

By automating manual tasks and reducing the need for physical infrastructure, our cloud-based solution offers significant cost savings. This efficiency not only reduces operational costs but also allows for the allocation of resources to other strategic areas.

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+1 (855)-261-6918

info@cloudbyz.com

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Safety & Pharmacovigilance

Improve patient safety, optimize global compliance, and make better decisions faster.

Safety & Pharmacovigilance