Author: Dr. Chitra Lele, Sciformix Corporation
Biopharmaceutical companies are facing new challenges and opportunities, caused in part by globalization as well as the growing and aging populations worldwide. Globalization increases the inter-dependence between countries and economic integration creating one market.1 As a result of this, outsourcing is growing in importance with reason to consider it going far beyond arbitrage.
Furthermore, the same companies are facing increasing pressure to simultaneously improve productivity and cost efficiency whilst improving quality and compliance in order to remain competitive in the market. Regulatory scrutiny throughout the product lifecycle has also significantly increased as regulatory authorities’ focus on product benefit versus risk profiles.2
Companies are also expanding their product portfolio and moving into new geographies, each with unique nuances. Drug discovery and development is becoming more complex and resource intensive despite technological innovations increasing automation of the processes. The result of these increased pressures and complexities is that the amount and types of outsourcing in the industry has dramatically escalated. The strategies adopted are diverse and can include captive centers, joint ventures with global outsourcing companies, expanded use of full service clinical research organizations (CROs), functional service providers (FSPs) as well as any other creative approaches companies can envision. An organization’s decision to outsource is dependent on a great number of internal factors including its product portfolio, stage/phase in the product lifecycle, therapeutic areas, internal capabilities, expected case volume and complexity.