CQ Safety & Pharmacovigilance (PV)
When it comes to patient safety, data quality becomes critical
Bolster patient safety concerns by effectively capturing and analyzing safety data and proactively uncovering adverse event trends
The clinical research your organization conducts has the potential to deliver life changing medical advancements. Critical to the success of any clinical trials is the early identification and management of relevant safety data into usable information for regulators and companies. Failing to properly monitor, assess and report safety concerns puts patients as well as the investment in your product at risk.
The occurrence of an adverse event is not always during the patient’s visit to the Healthcare Center. Issues such as not conducting a follow-up on a case or patients failing to remember all the relevant information leading to a poor report can lead to a significant level of risk of non-compliance of regulatory requirements, major or critical inspection findings, and most importantly, endangering patient safety. This is why, the quality and efficiency of the processes and management of your pharmacovigilance system are critical. It requires dedicated and minutely detailed management of clinical trial safety risks.
Early identification and management of adverse events is critical to the success of any clinical trial
CQ Safety & Pharmacovigilance powered by Cloudbyz empowers sponsors, CROs, and sites to align with international, national, and regional regulatory frameworks of clinical trials. The solution includes integrated risk management capabilities, to help various stakeholders make safety-related decisions using the power of data, advanced analytics, and predictive insights. CQ Safety & Pharmacovigilance (PV) software makes it easy to streamline all processes related to global clinical safety & pharmacovigilance compliance and overall patient safety.
Make your processes more resilient, scalable, and accurate for end-to-end global Case Management. The solution allows coordinators and other team members to track each case from intake, categorization, processing to resolution.
Adverse Event Management
Automate the collection, management, and real-time oversight of adverse events for better informed decisions and improved compliance. The solution supports flexible report data tracking and management. It also ensures secure and centralized storage of patient information and lab test results.
Adverse Event Reporting
The regulatory report generation is configured for report seriousness and causality; it complies with pharmacovigilance rules, and all scheduled reports are stored centrally. The centralized repository of events data further enables identifying patterns, preventing their recurrence in the future, identifying root causes, and taking corrective action with agility.
The solution provides full electronic reporting for both Pharma/Bio and Medical Device including periodic adverse drug experience report (PADER), periodic safety update report (PSUR), alternate summary reporting (ASR), and Development Safety Update Report (DSUR). Adverse event information is easily accessible for investigators, sponsors, and IRBs. In addition, with Event Analysis, narrative case descriptions can easily be generated to add to MedWatch 3500A and BfArM reports.
The CQ Safety & Pharmacovigilance solution is designed to enhance pharmacovigilance by recording and managing details regarding products and dosage regimens while building associations for pharmacovigilance data accuracy.
The CQ Safety & Pharmacovigilance solution provides advanced analytics capabilities with data-backed predictability, proactive pharmacovigilance, scalability, and cost-effective support. It includes next-generation data visualization features, dashboards, and reports that help all stakeholders have a finger on the pulse of all the data related to daily pharmacovigilance operations, risk factors, and metrics that directly impact patient safety.
Support Your Entire Clinical Organization
End-to-end visibility into processes improves patient, case, and product management for increased pharmacovigilance compliance.
Documentation of all cases, patients, products, and events ensures conformance and compliance.
The centralized view of data, data integrity, adverse event management, reporting, and analysis help improve clinical trial outcomes and compliance.
360-degree view of all operations and processes in real-time to quickly identify systemic issues, reduce cost, and prevent recurrences.
Automated workflows, centralized repository of documents, and data management enable real-time monitoring and tracking site performance.
Ensure pharmacovigilance compliance of clinical trials and protocols through streamlined, automated processes across the entire lifecycle.
Provide centralized access to all documents, patient data, and lab results.
Dashboards and reports provide holistic views of all processes to ensure alignment with all applicable regulations.
Monitor, generate, and submit reports and store all events-related documents for improved regulatory compliance.
Enable streamlined and efficient clinical quality improvement processes while being compliant with cGCP and all applicable regulations.
Key CQ Clinical Solution Features
End-to-end case processing to track each case from intake, categorization, processing to resolution.
Adverse Event Management
Document, report and monitor adverse events from the point of data capture through study completion
Adverse Event Reporting
Regulatory report generation for pharma/bio and medical device based on pharmacovigilance rules pre-configured for report seriousness and causality
Record and manage details regarding products and dosage regimens
C-suite executives and team members can leverage bundled reports to gain insights into daily pharmacovigilance operations