Cloudbyz Safety and Pharmacovigilance (PV) software 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 software 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.
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.
Our solution allows the capture of adverse events from a multitude of channels, including call centers, emails, mobile apps, web portals, and even social media platforms. This ensures a comprehensive coverage and increased real-time response, improving the scope of data collection.
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.
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.
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.
By opting for Cloudbyz's Pharmacovigilance solution, you stand to gain: