Life Sciences companies are increasingly focusing on patient safety and pharmacovigilance initiatives to improve to improve patient safety and track adverse events for drugs and theraphies.

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



CASE MANAGEMENT

Robust multi-channel case in take process and manage inbound hotline calls and status updates about both case and track cases and events from patients, MDOs and Clinical Specialists. 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 including the person providing the case-related information. Track and manage patient information such as the patient's past 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.

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

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. Helps you to view all scheduled reports and you can also schedule new report.

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

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.

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