Pharmacovigilance Operations

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

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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.

Our 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.

photo of a doctor shaking hands with a patient

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.