iVigee's Boutique Approach to Pharmacovigilance Outsourcing Redefines Industry Standards

Pharmacovigilance outsourcing has been used extensively to meet the ever-increasing regulatory burden and cost pressures. This is typically accomplished in piecemeal with products or human resources, and often driven by the lowest costs as the common denominator. It’s time for a paradigm change in delivering pharmacovigilance services in an integrative manner with a focus on the highest quality.

Managing challenging safety issues often requires experts who are experienced in pharmacovigilance, regulatory, toxicology, clinical medicine, and drug development. It requires a team of pharmacovigilance professionals with impeccable credentials in education and training who have worked across multiple therapeutic modalities and are battle-tested with regulatory agencies and health authorities across the globe.

Companies of all sizes and stages, except the largest and most sophisticated, seldom have access to or the capacity to provide these services internally. iVigee will launch a new Chief Medical Office led by Shui Ki Henry Seto, MD, FACC, FACP to provide Medical Services and Consultancy to serve this critical need. Along with Jan Petracek, MD, formal Head of Risk Management at the EMA and a DIA PV expert trainer as CEO and Marcela Fialova, MD, expert QPPV, DIA trainer as COO, the CMO Office will have unparalleled expertise and knowledge to assist and consult with pharmaceutical companies of all stages with any aspect of patient safety and pharmacovigilance.

As a US-educated and trained cardiologist with combined decades of clinical and physician executive drug development experience who has originated, designed, implemented, and operated a variety of pharmacovigilance and medical information insourcing, outsourcing, and FSP models in various-sized companies, I note only a single ingredient that will reliably bring success - the involvement of dedicated experienced pharmacovigilance professionals who are committed to patient safety. This is what I have deemed Boutique Pharmacovigilance Outsourcing - the antithesis of going to a big box store that tries to sell everything to everyone at the lowest price. Outsourcing typically involves finding a cheaper resource or a product while quality is often sacrificed to productivity or timeline-based KPIs. Performance is often dependent on the intensity and expertise of oversight by the client or sponsor.

Successful case studies include:

• elimination of case backlogs while operating with industry-leading compliance rates;
• expanding geographic coverage with a fraction of the costs of an internal build;
• adopting industry-leading automated technological solutions to obviate building from scratch and redeployment of internal valuable resources by using ready-made GXP systems have been executed successfully with a combination of cost-avoidance, savings, and effectiveness under all types of models.

Inspection findings often cite a lack of vendor oversight, training, and quality. Both pharmaceutical and CRO industries cannot afford to conduct the pharmacovigilance outsourcing business as usual. Finding the lowest cost solution in piecemeal will only place patient safety at risk.

The vision for the new iVigee CMO Office aims to ensure the consultancy and medical services provided to our clients are cost-effective at the highest level of medical and pharmacovigilance standards with a focus on quality. Pharmaceutical companies of all sizes and stages will now have access to a new best-in-class pharmacovigilance outsourcing delivery model. After all, patient safety should always be the top priority.

Learn more: Medical Safety Advisory and Services