Friday 17 October 2014

Pharmacovigilance Services from WorkSure

Life Sciences companies need the operational burden to be taken away so they can focus on the science of safety. They need flexible, scalable operations that run like a well-oiled machine while achieving quality and efficiency objectives. Compliance should be “business as usual” so companies can concentrate their attention on strategic safety governance, benefit-risk management and proactive safety surveillance.

It is possible to avoid the growing operational problem by moving toward an externally managed solution that consistently and routinely achieves required business outcomes using a globally integrated model. As your partner, WorkSure will deliver Pharmacovigilance outsourcing services through a global operation with an unprecedented compliance record—no critical findings from audits and inspections by clients’ QA and the regulators.

WorkSure helps the Life Sciences industry achieve better pharmacovigilance through regulatory compliance, higher productivity, higher quality and strategic safety outcomes.

Match the solution to the challenge

The need for PV outsourcing is a reality for most Life Sciences companies. As we have implemented these services for our customers, we have adapted according to their operating models, outsourcing maturity level and the scale of the challenge being tackled. We achieve a competitive price point by leveraging our offshore delivery network, and we offer a range of services that can be tailored exactly to match the demands of any context:

1. Discrete, specific need: Services to augment a PV organization’s existing operations using its own systems and processes; additional capacity provided as needed, with direct oversight of a flexible pool of outsourced resources.

2. End-to-End Pharmacovigilance: Fully managed service spanning end-to-end pharmacovilance services, integrating seamlessly and using a pharmacovilance organization’s systems and processes; strengthened through our advanced operational excellence capabilities and analytics capability.

3. Next-generation solution: Fully managed service spanning end-to-end PV services, integrating seamlessly and using a PV organization’s systems and processes; strengthened through our advanced operational excellence capabilities and analytic capability.

Build in quality and mitigate the risk of change

Every project does not have to be a large-scale transformation. If you require tactical cost reduction with rapid implementation and the associated control and flexibility, we excel with this model. If you are embarking on a game-changing pharmacovilance transformation, however, introducing our services can be a significant facilitator of that transformation. We will help you drive your vision forward.

People—patients, healthcare professionals, policy makers and your employees—are at the heart of pharmacovigilance. Our change management and communications experience will help mitigate the risks of adopting new methods, letting you focus on the strategic vision and realize the ultimate patient safety benefits.

Lean, efficient processes, controlled through compliant standard operating procedures, are the backbone of every service we deliver. We can help you to simplify your global workflow with high throughput, replace manual steps with automation, and build in quality to help you get things right the first time.

Building the future success to Pharmacovilance

WorkSure is deeply committed to helping pharmaceutical companies address current challenges as well as pre-empt future issues. Through WorkSure accelerated services, we bring the next-generation, fully integrated business service that delivers optimized processes across the clinical, regulatory and PV functions around the globe. This solution, supported by outsourced operational activities and enabled by customizable technology platforms, helps pharmaceutical companies bring drugs to market faster, at less cost and with reduced execution risks.

Further, the solution is leading edge, supporting maximum efficiency in R&D as well as the management and measurement of R&D processes. Advanced data analytics drive innovation across companies and help release the full value of the data. By adopting an externally managed solution that consistently and routinely achieves required business outcomes using a globally integrated model, phamacovigilance organizations will gain the freedom to focus on the science of safety.

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