Drug safety and pharmacovigilance have always been dynamic clinical disciplines for effective drug regulation systems. Construed as ‘the science for detection, assessment, understanding and prevention of adverse drug-related problems’ by the World Health Organization (WHO), Pharmacovigilance is an integral part of clinical research which is flourishing at a remarkable rate in numerous countries. Today abounding pharmacovigilance centers are working for drug safety monitoring in global pitch, however, at the turn of the millennium pharmacovigilance faces considerable challenges in aspect of ameliorated safety and monitoring of drugs. Nourishing the achievement of operational excellence in Pharmacovigilance (PV) by employing the right mix of people, process and technology is Foresight Group that proffers a blend of functional and technical knowledge of global regulations to bring pragmatic and cost-effective solutions to pharmacovigilance and risk management problems.

Headquartered in Switzerland with offices in Noida, Foresight is the largest implementation partner for Oracle Health Sciences’ PV software platform, the market leader in the Drug Safety space that serves as the technology backbone for global PV operations for enormous companies. The company’s accomplished team in Europe, Japan, India and the United States assists clients address business challenges in regulatory compliance, process optimization, hosting, and application management services. Talking about one of the successfully delivered projects, Pravin Nath, Managing Director of Foresight India says, “Foresight enabled a CRO to consolidate and migrate a significant number of single Oracle Argus instances into one multi-tenant system that is now hosted and managed by foresight’s services team.”

Unlike in the past, where clinical, safety and regulatory had clear hands off between them, and clinical used to develop a product, at the same point it used to become available in market and regulatory managed it in the portfolio. Now its different, as even if product is launched in the multiple geographies, customers easily have a product that is still in clinical for some indications, marketed for others, under NDA in some markets, under safety surveillance with one regulator and in a JV with a partner in a subset of markets. The inter-relationships between all the teams is far more complex. This used to be the exception, but is now the norm. So there is a data exchange and process complexity that didn’t exist before. The company claims ‘automated interfacing’ with regulatory and clinical systems as the key to safety compliance and provides automated integration services based on a deep understanding of the processes and systems on both sides. Further, Foresight is able to provide increased levels of automation by setting up efficient workflows, integrations with other enterprise systems, automating narrative/letter writing, and automated submissions to authorities using e2b electronic submissions/fax/emails.

Foresight has a rich pool of services with Business Process creation/harmonization, Signal detection and Process definition being some of its business solutions. Besides, the company also provides its clientele with technology solutions like Data Migration, Analytics and Electronic reporting, Hosting and Managed Services Cloud offerings for Oracle’s safety suiteand its proprietary Product Suite. Foresight Products suite includes PVQ (SafetyQuerying and Reporting), PVM (Compliance tracking and CAPA), Codex (Coding tool) and PVI (Case Intake). Foresight is a niche provider of specialized Safety services and hence is able to build deep domain skills by way of focused hiring, training and project orientation.

The company regards its establishment as a global brand and a trusted partner of Safety Solutions across the markets of North America, Europe and Japan, as its single biggest achievement. Having 250 trained people as PV consultants in August 2015 and with expansion plans to be 300 by the 1st quarter 2016, Foresight plans to focus on Mobility in upcoming years, allowing companies to go beyond desktops and offer the ability to capture side effects and render operational and compliance dashboards on mobile devices. Foresight aims to bring a larger percentage of its existing and new clients on to the Foresight cloud while offering them high value ongoing Managed services. The company yearns to see safety spread beyond medicinal products to other areas such as Ayurveda, Homeopathy, and Cosmetics to other adjacent squares such as spices and wellness products.