Safety & Pharmacovigilance

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

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Safety & Pharmacovigilance

Our solution accelerator built 100% native on Salesforce Service Cloud offers 360 degree view across R&D and commercial and helps enable pharma, bio-tech and medical devices companies to make faster and better safety decisions, optimize global compliance and easily integrate risk management.

Product Features

Case Management

Our SPV solution features a robust multi-channel case intake process. Manage inbound hotline calls and status updates about cases, and track cases and events from patients, MDOs and Clinical Specialists. Our solution enables a highly scalable, end-to-end safety process providing automated global case processing, periodic reporting, E2B intake and submission.

Adverse Event Management

Comprehensive, collaborative and user-friendly periodic AE reporting encompassing PSUR, ASR, DSUR, PADER (and more) reduces the time required to produce periodic submissions, while increasing their accuracy. The Event information enables you to encode adverse events, record the criteria for the seriousness of each event, and display the results of automated assessments.

Patient Management

Track and manage reporter data, including the person providing the case-related information. Track and manage patient information such as the patient's medical history and current conditions, and laboratory tests and test results. The medical information entered here could be very useful to the person analyzing the event, and accessible on one centralized solution.

PRODUCT MANAGEMENT

Track and manage details about products and dosage regimens. The Products information contains the name of the drug that has been entered. For blinded clinical studies, the blinded clinical investigational product name can be tracked.

MEDWATCH INFORMATION

The solution enables you to enter additional details required for the MedWatch 3500A Drug Report. The information is used along with case and adverse event details to generate regulatory and MedWatch reports.

ANALYTICS & REPORTING

Cloudbyz Safety solution is an accelerator which extends Salesforce.com Service Cloud for pharma, bio-tech and medical devices companies to provide and manage drug safety and pharmacovigilance to their products and brands.

Regulatory Reports

Our solution enables the regulatory report generation based on business rules and configured to look at any type of criteria, but are mainly configured to look at Seriousness, Causality and Outcome. View all scheduled reports and schedule new reports, all from one place.

Event Analysis

The Event Analysis enables you to generate or view a narrative description of the case, together with other notes. In addition, it also enables you to enter information required for generating the MedWatch 3500A and BfArM reports.

Service Cloud Extension

Our Safety solution is an accelerator which extends the Salesforce.com Service Cloud for Pharma, Biotech and Medical Device companies to provide and manage drug safety and pharmacovigilance to their products and brands.

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Call us at (312)-763-8040 or Email : info@cloudbyz.com

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