---
title: Leading CRO selects Cloudbyz PV for to streamline safety for complex post-marketing safety study
description: "Case Study: Leading Pharma company selects Cloudbyz to streamline safety for its global clinical trials"
---

[Resources ](https://blog.cloudbyz.com/resources)

# [Leading CRO selects Cloudbyz PV for to streamline safety for complex post-marketing safety study](https://blog.cloudbyz.com/resources/case-study-leading-pharma-company-selects-cloudbyz-to-streamline-safety-for-its-global-clinical-trials-0)

 Written by [Tunir Das](https://blog.cloudbyz.com/resources/author/tunir-das) | Oct 3, 2024 2:06:22 PM

#### **Customer Overview**

A leading CRO, specializing in managing large-scale pharmacovigilance (PV) studies, was tasked with running a complex post-marketing safety study for a global pharmaceutical client. To ensure compliance with evolving regulatory demands and streamline operations, the CRO turned to **Cloudbyz** for an integrated pharmacovigilance (PV) solution.

#### **Challenges**

The CRO struggled with several challenges due to manual safety data management and disconnected legacy systems, leading to inefficiencies in processing serious adverse events (SAEs) and safety reports. The lack of real-time visibility across multiple sites and geographies made it difficult to meet strict regulatory timelines, while duplicated efforts increased operational costs. Additionally, siloed safety data from various sources hindered effective collaboration with sponsors and partners, further complicating the study’s management.

**What the CRO needed:**

- A **centralized PV system** to unify safety data and streamline global study operations.
- **Compliance with global regulatory standards**, including FDA, EMA, and other local requirements.
- **Real-time visibility** and reporting to improve study oversight.
- **Automation** to accelerate safety report processing and reduce manual errors.
- Seamless **collaboration between internal teams, sponsors, and external stakeholders**.

#### **Solution**

The CRO implemented **Cloudbyz’s unified Safety & PV database**, built on the **Salesforce cloud platform**, to efficiently manage all aspects of the post-marketing PV study. The solution provided comprehensive safety data management, integration with **MedDRA** and **WHODrug coding dictionaries**, and automated safety report generation.

#### **Benefits**

With **Cloudbyz’s Safety & PV solution**, the CRO gained full visibility across all study sites, enhanced safety reporting accuracy, and ensured compliance with global regulatory requirements. Key benefits include:

- The CRO reached **90% compliance** with US safety reporting timelines, ensuring **timely and accurate safety submissions**. 
- **Audit preparation time was reduced by 30%**, improving overall compliance efficiency and reducing operational costs. 
- **Audit response times improved by 20%**, enabling quicker and more precise submissions during regulatory inspections. 
- The CRO successfully processed **87% of ICSRs** for **SAEs within 5 to 7 days.**

Additionally, the Cloudbyz system allowed the CRO to easily collaborate with the pharmaceutical client and other partners by providing **real-time data sharing** and **inspection-ready documentation**. The system also complied with all major regulatory frameworks, including **FDA 21 CFR Part 11**, **GCP**, **GAMP5**, **HIPAA**, and **EU-GDPR**, ensuring that all data handling was secure and compliant.

By adopting **Cloudbyz’s Safety & PV solution**, the CRO successfully managed a complex, large-scale post-marketing PV study, ensuring timely and compliant safety reporting while reducing operational inefficiencies. The **centralized, automated platform** empowered the CRO to deliver **high-quality safety data** and meet **regulatory demands** across multiple regions, strengthening its partnership with the sponsor and enhancing overall study outcomes.

[View full post](https://blog.cloudbyz.com/resources/case-study-leading-pharma-company-selects-cloudbyz-to-streamline-safety-for-its-global-clinical-trials-0)

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