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Safety & Pharmacovigilance (PV)

CQ Safety &
Pharmacovigilance
(PV)

Speed up risk/benefit decisions to improve safety with CQ Safety & Pharmacovigilance

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

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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.

Case Management

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.

Case Management
Adverse Event Management

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.

Adverse Event Reporting
Product Management

Product Management

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.

Advanced Analytics

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.

Advanced Analytics

Support Your Entire Clinical Organization

Sponsors

Sponsors

End-to-end visibility into processes improves patient, case, and product management for increased pharmacovigilance compliance.

Investigators

Investigators

Documentation of all cases, patients, products, and events ensures conformance and compliance.

CROs

CROs

The centralized view of data, data integrity, adverse event management, reporting, and analysis help improve clinical trial outcomes and compliance.

Management

Management

360-degree view of all operations and processes in real-time to quickly identify systemic issues, reduce cost, and prevent recurrences.

Sites

Sites

Automated workflows, centralized repository of documents, and data management enable real-time monitoring and tracking site performance.

Clinical Development

Clinical Development

Ensure pharmacovigilance compliance of clinical trials and protocols through streamlined, automated processes across the entire lifecycle.

Monitors

Monitors

Provide centralized access to all documents, patient data, and lab results.

Clinical Operations

Clinical Operations

Dashboards and reports provide holistic views of all processes to ensure alignment with all applicable regulations.

Regulatory/Safety

Regulatory/Safety

Monitor, generate, and submit reports and store all events-related documents for improved regulatory compliance.

Quality

Quality

Enable streamlined and efficient clinical quality improvement processes while being compliant with cGCP and all applicable regulations.

Key CQ Clinical Solution Features

Key CQ Clinical Solution Features

clinical management features

Clinical Trial Operations

Case Management

End-to-end case processing to track each case from intake, categorization, processing to resolution.

Study Start-Up

Adverse Event Management

Document, report and monitor adverse events from the point of data capture through study completion

CTMS

Adverse Event Reporting

Regulatory report generation for pharma/bio and medical device based on pharmacovigilance rules pre-configured for report seriousness and causality

eTMF

Product Management

Record and manage details regarding products and dosage regimens

EDC

Advanced Analytics

 C-suite executives and team members can leverage bundled reports to gain insights into daily pharmacovigilance operations

Related Insights

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