Safety and Risk Management

Pharmacovigilance

Delivering drug safety services from case intake to case processing and submission

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions.  Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Our LEAN processes and flexible engagement model allows us to quickly respond to volume fluctuations which cause ubiquitous resourcing issues. As a result, we deliver value to our clients by way of cost savings and process efficiencies. Read our whitepaper to learn more. Our quality management system and oversight ensures consistent, high quality and compliant deliverables. From a technology and infrastructure standpoint you gain by taking advantage of the investments we’ve made and the best-in-class tools we use.

You may choose to outsource niche or end-to-end pharmacovigilance services. With our modular approach everything is standardized for maximum efficiency. Organizations requiring end-to-end PV support can take advantage our PV-in-a-box solution – a shared resources and pay-per-use managed service offering.

Our project managers track daily, weekly and monthly metrics for quality, productivity and efficiency, and proactively work with our clients to strive to do better. Our expertise in regulatory reporting of ICSRs and clinical trial SAEs, signal detection, risk management along with technology and process automation provides us the ability to support and integrate multiple applications. By continuously improving our efficiency, cost improvements and productivity gains can be transferred to the client.

The winning combination of our highly skilled people, streamlined processes and innovative tools means that redundancies, gaps and delays are eliminated at all steps of the process – intake and allocation, triage, data entry, peer review, medical review and reporting, and there’s a smooth execution of the entire process with reduced overall timelines.

Resources

SRM-brochure-thumbSafety and Risk Management capabilities brochure

Sciformix’s Integrated Drug Safety solution seamlessly interweaves and synchronizes case processing (ICSR), aggregate reporting (PSUR, PADER, PBRER, ASR) and risk management across all phases of the product lifecycle. Our scientific experts aggregate and evaluate safety information from all sources, including individual cases, published safety data and competitive products to facilitate evidence-based proactive drug safety decisions.

Download information on our Safety and Risk Management services. (PDF)

SmartSourcing-thumbSmart sourcing strategy for pharmacovigilance vendor selection

Strategic planning, sourcing and implementation of pharmacovigilance operations are multi-dimensional activities that require consideration of factors across the spectrum. Over the past few years there has been a positive increase in the quality and quantity of safety processes being outsourced. The trend is largely due to evolution of mature processes; risk mitigation strategies and increase in vendor experiences that has helped the sponsor balance core in house strength and leverage the service provider’s capabilities. Though approach towards outsourcing pharmacovigilance is largely tactical, strategic partnership with a vendor is not uncommon.

Download information on our Smart sourcing strategy. (PDF)

ScignalPlus-thumbScignal Plus

Scignal Plus provides superior, efficient signal detection by incorporating computational algorithms for a new method and previously known methods of signal detection. It has several distinct and important advantages over other products that are available in the market.

Learn more about Scignal Plus. (PDF)