4C Pharma Selects Oracle Argus Safety Cloud 8.1 to Modernize and Gain E2B(R3) Compliance

Safety Suite for Life Sciences and Biopharmaceutical Industry Helps CRO Deliver Increased Efficiency in Serving Market, Flexibility and Compliance
4C Pharma Solutions
4C Pharma Solutions
PISCATAWAY, N.J. - Nov. 16, 2017 - PRLog -- 4C Pharma Solutionsis excited to announce the utilization of pre-validated Oracle Argus Safety Cloud Service 8.1 and Oracle's Backwards Forwards Compatibility (BFC) tool to convert E2B (R3) XML files to R2 format for its clients. 4C Pharma, a Service Provider Organization focused on providing best-in-class solutions for pharmacovigilance activities, selected and implemented Argus's SaaS-based model, based upon their prior version experiences in improving quality and efficiency for their clients through seamless safety integration and automation.

Argus Safety Cloud Service is a complete pharmacovigilance software system designed to solve the pharmaceutical industry's toughest regulatory challenges. The cloud-based solution supports drug safety business processes via a browser-based multi-tenant platform, with Test and Production instances for each client that have enhanced security and reduced IT maintenance. With the multi-tenancy feature in Argus Safety Cloud, 4C Pharma can provide services to multiple sponsors, biotechnology and medical device organizations at the same time, while keeping their data isolated in the pharmacovigilance system. 4C Pharma's standardization on Argus Safety Cloud's multi-tenant platform provides efficiency, value and security for both trial sponsors and contract researchers.

"Partners like 4C Pharma are well established specifically in the discipline of pharmacovigilance," said Bruce Palsulich, VP of Product Strategy, Safety, Oracle Health Sciences. "With Oracle Argus Safety Cloud supporting this phase of clinical trial efforts across therapeutic areas, 4C Pharma is able to focus on their specialty, expertise in clinical science."

4C Pharma will provide benefits to the industry with Argus Safety Cloud's multi-tenancy feature enabling multiple clients to reside as separate and unique tenants on a single platform with their data completely segregated and restricted to authorized users. This multi-tenancy enables 4C Pharma to achieve standard configurations for its clients, such as code lists, workflow steps, and user/new client setup, across clients or to have different configurations for specific clients. 4C Pharma's focus across all trials, with expertise in oncology, central nervous system, and having doctors on staff with a broad range of therapeutics' expertise, gives the benefit of timely ability to set up new trials based on an existing configuration and authorize users for the new client faster than before.

"We build and operate our trials with the trust imparted to us by our sponsors and biotechnology organizations. We use leading solutions, such as Oracle Argus Safety Cloud to enhance the quality and outcomes that our clients have come to depend on for accurate, timely and value-based research." (Dr. Madineni, CEO)

4C Pharma Solutions has also selected the Oracle Argus Safety Cloud Service 8.1 pre-validated system as the most feasible solution for pharmaceutical companies and contract researchers needing quick deployment and low cost of ownership. Version 8.1 has R3 compatible fields including null flavors making it an essential step towards future regulatory requirements that are fast adopted by authorities across the globe. BFC Tool is a stopgap solution to convert R3 XML files sent by European Medicines Agency to Marketing Authorization Holders into R2 format for further processing in Argus.

About 4C Pharma Solutions:

4C Pharma Solutions is a comprehensive healthcare solutions provider company, specializing in end to end Pharmacovigilance, Literature Search, Medical Information Call Centre, Affordable Argus Hosting Solutions, Regulatory Affairs and Medical Writing Solutions. 4C Pharma Solutions was named one of the Top 10 CROs by PharmaIQ and is a trusted Gold Oracle Partner. For more information login to www.4cpharma.com

About Oracle

The Oracle Cloud offers complete SaaS application suites for ERP, HCM and CX, plus best-in-class database Platform as a Service (PaaS) and Infrastructure as a Service (IaaS) from data centers throughout the Americas, Europe and Asia. For more information about Oracle, please visit us at www.oracle.com.


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