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Raising Clinical Trial Safety Standards With Cloudbyz Safety Management Solution

Written by Pooja Sood | Aug 24, 2021 10:16:00 AM

Overview

Cloudbyz has positioned itself as a reputable and highly preferred CTMS solution provider in the life science domain. We have received numerous positive responses and feedback for our deliverables from across the globe. Our rapidly growing clientele and loyal customer base represent our product delivery with a consistent promise to serve.

One such product delivery was made recently when Cloudbyz was approached by a medical technology company. Our client was facing constraints in safety management and surveillance requirements mostly due to their conventional practices.

Company Information

Our client is a globally renowned American medical technology enterprise specializing in manufacturing cardiovascular products and services. The company was founded over 60 years back. It registered a revenue of ~US$430cr in 2019 and is operational with a massive resource strength of 14,000 employees.

Constraints Faced by the Client

Cloudbyz analyzed that our client was using conventional systems that constrained its capacity in the assessment of adverse events and regulatory adherence. Additionally,  the usage of manual labor significantly increased the time and cost resulting in reduced efficiency. 

Post thorough analysis we realized that our client required software solutions for end-to-end guidance through post-marketing surveillance, largely into governing compliance. Cloudbyz also intended to deliver a reduced probability of errors.

Solutions Delivered by Cloudbyz

We moved forward with a systematic approach and proposed the deployment of Cloudbyz Safety Management Solution. This solution is expected to facilitate safety/adverse event tracking, documentation, collaboration, and clinical trial management processes in the client’s focused business units.

Learn more about Cloudbyz Safety & Pharmacovigilance features

Apart from the common set of features, Cloudbyz Safety Management Solution enabled  other features that included:

  • Auto-generated notification/alerts to investigators next in process/line,
  • Configuration for users and profiles
  • Patient management
  • Site management
  • Permission sets, and more.

Our solution is built on the Salesforce platform and therefore enables seamless narrative character and EDC integration with existing infrastructure.

Not only did we implement the solution, but also provided PPT-based training modules to our client’s employees to cope up with the operational requirement of the solution and averse to any contingencies, if any.

The Final Results

Our client’s major concern was to gain a complete post surveillance solution and this was successfully catered to through end-to-end automation of the entire post-marketing surveillance process.

Through our automated cloud-based safety solution facilitated disbursement of consent email/auto-reply emails, report generation (eg: MDCG report, Complaint handling, DSMB, etc.), and submission to regulatory affairs.

As promised, our client benefited manifolds with Cloudbyz Safety Management Solution with dramatically reduced human interventions and manual errors while delivering easier and faster-to-market possibilities.

About Cloudbyz:

Cloudbyz is a cloud-based, salesforce-built clinical trial solution provider to the life science industry delivering intuitive, flexible, and scalable products with rapid deployment functionality. Our Cloudbyz Safety Management Solution enables safety services especially in phase iv of the clinical trials. We also provide pharmacovigilance services.