Compliance Quest - Safety & Pharmacovigilance (PV) Software
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.
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.
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.
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.
