4C Pharma Solutions

Part of Panel discussion on the " Future of eCtd"

4C Pharma Solutions at

The 15th Pharmacovigilance Summit 2018, London Uk

LatesT on 4C

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

4C Pharma Solutions in the News

4C Pharma Solutions named as one of the top 10 CROs.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.

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4C Pharma Solutions is proud to announce the launch of E2B(R3) compliant systems.4C Pharma Solutions is excited to announce the launch of prevalidated Oracle Argus Safety 8.1 and Backwards Forwards Compatibility (BFC) tool to convert E2B (R3) XML files to R2 format.

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Pharma Digital Transformation

Safety Suite for Life Sciences and Biopharmaceutical Industry Helps CRO Deliver Increased Efficiency in Serving Market, Flexibility and Compliance. 4C Pharma Selects Oracle Argus Safety Cloud 8.1 to Modernize and Gain E2B(R3) Compliance.

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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

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