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4C Pharma Solutions named as one of the top 10 CROs, by Pharma IQ 

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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

Piscataway, New Jersey, USA., October 16, 2017 – 4C Pharma Solutions is 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 (NYSE:ORCL), please visit us at www.oracle.com.

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4C Pharma Solutions is proud to announce the launch of E2B(R3) compliant systems
4C Pharma Solutions named as one of the top 10 CROs

Top 10 Clinical Research Organisations in the Pharma & Biotech Industry – 2016
Contributor: Miss Chanice Henry

Posted: 03/15/2016

The profitability levels in the Contract Research Organisation (CRO) market are tied to a collection of factors – mainly the R&D pots of bio and pharma firms and the amount of trials being outsourced. [1]
The global healthcare CRO market has been forecasted to reach US$45 billion by 2022, according to new research. (2) In terms of market shares, the geos rank as follows: North America, Europe, Asia Pacific, with China and India expected to see dramatic growth within this period.
In light of this growing market, the Pharma IQ community was invited to rate which firms would appear in their top 10 CROs.

Our research base, made up of participants from mainly big pharma, SME pharma and solution providers, noted that the functions they are most likely to outsource to CROs was clinical monitoring followed by pharmacovigilance.

When choosing a CRO, quality of services was seen as the most important factor, closely followed by reputation and level of experience.

In regards to what it would take to end a relationship with their CRO, 88% of our participants stated that lack of quality would be the deal breaker, also level of mistakes would go a large way to apply tension on CRO relations.

Despite this, all of our participants rated their current relationships with their CRO as satisfactory and above. In terms of which firms our participants rated as their Top CROs, the following firms were voted to appear in the Top 10 of the chart.

Pharma IQ’s Top 10 Ranking of CROs

  • PPD – Pharmaceutical Product Development, LLC
  • Covance
  • Quintiles
  • ICON plc
  • PRA
  • INC Research
  • Parexel
  • SGS, PharSafer, Integrium, LLC, 4C Pharma Solutions (Joint 8th)
  • Vigilex, Argint International (Joint 9th)
  • Accenture

Those nominated included:

  • Inventiv
  • InClin, Inc.
  • BioClinical

Source : http://www.pharma-iq.com/clinical-supply/articles/top-10-clinical-research-organisations-in-the

4C Pharma Named As One Of Oracle Health Sciences 93 Emerging Biopharmaceutical Customers.

Oracle’s industry-leading clinical R&D cloud solutions help emerging biopharmaceutical firms optimize clinical development productivity and facilitate compliance, while delivering an affordable pricing model and rapid deployment

Redwood Shores, Calif.—Sep 29, 2015

Emerging biopharmaceutical organizations face a growing number of regulatory requirements and, due to increased competition1, acute pressure to speed time to market. Today, Oracle Health Sciences announced that 93 of these emerging biopharma organizations worldwide have become new customers in the past year, adopting Oracle Health Sciences solutions to succeed in this rapidly evolving market and deliver drugs to patients faster.

Biopharmaceutical organizations, including sponsors such as Accera and NewLink Genetics and contract research organizations (CROs) FMD K&L and 4C Pharma Solutions, selected Oracle Health Sciences solutions to manage their end-to-end clinical trial processes, boost clinical development productivity, facilitate compliance, and build scalable, affordable platforms for growth.

“Oracle has long been a trusted partner working alongside smaller, emerging firms by developing innovative solutions to help them grow,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “Our industry-leading clinical development, management, and safety solutions deploy rapidly and scale on demand, empowering emerging biopharma’s to optimize clinical productivity, focus resources on innovation, and manage critical regulatory requirements with confidence.”

With the robust functionality of the Oracle Health Sciences suite of industry-leading cloud solutions2 such asOracle Health Sciences InFormOracle Health Sciences IRTOracle ArgusOracle’s Siebel Clinical Trial Management System, and Oracle Health Sciences ClearTrial Plan and Source Enterprise Edition Cloud Service, these emerging organizations can now optimize productivity and navigate complex regulatory compliance requirements with ease.

FMD K&L adopted Oracle Health Sciences InForm to help ensure data accuracy and efficiencies.

“We are dedicated to providing high-quality results to get our clients’ drug or medical products approved quickly,” said Dr. Xin Ke, president, FMD K&L. “Oracle Health Sciences InForm is a proven, industry-leading clinical data management system that enables us to raise the standard of excellence through accuracy and consistency on a continuous basis. Additionally, the ability to collaborate with Oracle on developing industry standards and implementation best practices has been invaluable in improving the quality and efficiency of our services.”

The Oracle Health Sciences cloud platform also provides an efficient model for predictable costs. Accera, a biotechnology company focused on conditions affecting the central nervous system, uses cloud-based Oracle Health Sciences ClearTrial Plan and Source Enterprise Edition Cloud Service to model scenarios for future trials.

The solution helps Accera to communicate the implications of different scenarios to investors and other stakeholders. It also gives Accera a benchmark for cost comparisons, and helps with financial projections and forecasting for each scenario. This allows Accera personnel to use time and resources more efficiently in the critical planning stages of their clinical development programs.

4C Pharma Solutions and NewLink Genetics use Oracle Argus Safety to gain greater insight into product-safety issues, improve productivity, and streamline safety reporting.

“As the life sciences industry becomes more regulated in reference to drug safety, we believe in providing customized, reliable, cost-effective, and global solutions while building long-lasting relationships to provide a great experience,” said Yathendra Madineni, M.D., CEO, 4C Pharma Solutions. “We build with trust, prove with quality, and truly make our partners’ requirements our passion. With Oracle Argus Safety solutions, our team can help our partners focus on research and innovation while we take care of the rest.”

NewLink Genetics is a biopharmaceutical company focused on discovering, developing, and commercializing immuno-oncology products that activate the body’s immune system to identify and attack cancer cells. By implementing the centralized database within Siebel Clinical Trial Management System, NewLink Genetics can manage its clinical trial activities and improve relationships with investigators, from early to late-stage studies.

“We develop multifaceted treatment strategies and several immuno-oncology agents through clinical trials enrolling patients at sites worldwide,” said Eugene P. Kennedy, M.D., vice president of Clinical and Medical Affairs, NewLink Genetics. “As we push forward to bring much needed treatment options that will revolutionize the way we treat patients with cancer, our team utilizes Oracle Health Sciences solutions for real-time visibility into our operational performance and regulatory compliance requirements.”

By offering a tailored business model to address the unique needs of the emerging biopharmaceutical market, Oracle Health Sciences provides these emerging firms with access to an innovative, affordable, and best-of-breed suite of e-clinical solutions. Further, the Oracle CRO Advantage program provides CROs serving the biopharmaceutical sector with a portfolio of integrated technologies; business development, sales enablement, and training solutions; and joint marketing opportunities that can enhance market success.

The entire article can be found here: https://www.oracle.com/corporate/press/oraclehealthsciadds93customers-092915.html

Pharmacovigilance In-house vs Outsourcing Critical Decisions

On a good note, the pharmaceutical industry is expanding both in size and global reach, but at the same time facing new and more complex challenges heavily impacting Pharmacovigilance Systems. These systems must keep up with product transformation, technology advancement, and constantly changing regulatory requirements while performing their core activities of product benefit-risk assessment and management responsibilities.

Events of the last two decades, including more comprehensive and conscientious safety documentation and review processes for drug approvals, along with increased regulatory warnings and consumer awareness on adverse drug reactions, have made product safety as one of the top issues for pharma companies, consumers and regulators. Safety concerns have prompted global imperatives for submitting significant specific product information efficiently and effectively within timelines, as well as stipulations for new levels of safety data transmission and transparency.

Because of these challenges, pursuit for robust compliance safety systems and experienced, knowledgeable and trained professionals has raised the cost and complexity of maintaining the infrastructure required to support pharmacovigilance activities In-House.

Apart from budgeting, an organization’s competency to calibrate compliant safety systems and quality operations may be limited by its capability to retain qualified people to staff its in-house PV department. Pharmaceutical industry must move to a more efficient, strategically focused PV capability in order to be less reactive, resource-intensive, and transaction focused, and become alternately a more proactive emissary for patient safety.

Many organizations are moving towards alternative delivery models to increase efficiency and capacity. These range from internal redesign to full-scale outsourcing, with many variations in between. Although elements of PV have been outsourced for a number of years, its efficiency and effectiveness has not been ideal and is only now maturing to the point where it can be considered more reliable and cost effective for companies to outsource their operations.

Outsourcing or engaging a third party partner for some or all PV operations allows the pharmaceutical company to target specific expertise that is difficult to develop internally. Additionally, by taking advantage of labor arbitrage and economies of scale, outsourcing can result in lower costs and increased efficiency. On the other hand, since mishandling adverse events can damage a company financially and harm its reputation, great care must be taken to determine which elements of this function can be delegated and to whom they can be delegated to.

A well implemented outsourcing program can drive significant benefit for the company like: 1. Converting fixed resource costs into variable, workload dependent charges especially with unpredictable volumes of cases 2. Reducing the number of resources to recruit, manage, and/or train 3. Improving on-demand access to unique expertise, intellectual property, and multidisciplinary knowledge 4. Increased business model and capacity flexibility 5. Improved efficiencies and Return on Investment. 6. Time available to focus on core R&D activities.

The Deloitte 2012 Global Outsourcing and Insourcing Survey found 57% of respondents (from 111 companies with $1 billion to $5 billion median revenue, and representing 22 primary industries) achieved cost savings of more than 10%. (Reference: Paper on Emerging PV business models by Deloitte)
Outsourcing providers can help companies address the increasing volume and complexity of regulatory requirements, add scalability to accommodate growing product portfolios and pipelines. They can also add economies of scale to help achieve aggressive cost and quality targets. This collaboration is driving further specialization and consolidation of talent within provider organizations and is providing opportunity for internal PV organizations to adopt a more strategic role to proactively improve the safety of their products. Given the innovation that is occurring in the PV outsourcing market, life sciences firms should actively consider outsourcing as a valuable tool as they look to address future requirements and opportunities.

We at 4C Pharma Solutions would be glad to discuss with you about assured cost savings and quality services in Pharmacovigilance activities. Write to us or call today.
4C Pharma Solutions

4C Pharma Solutions is a comprehensive healthcare solutions provider company, specializing in Pharmacovigilance, Argus Hosting, Medical Information Call Center, Regulatory Affairs, Medical Writing and Hosting Solutions

15 Corporate Place South 
Suite 402 
Piscataway 
New Jersey 
USA. 08854  
Off: +1(732)529-6989     
Email: info@4cpharma.com