Pharmaceutical companies, however, are faced with the challenges of reducing costs, improving drug-development processes and reducing time to market. This being said, the primary reason for CRO success in 2011 was the rise of the “strategic parternship model” between pharma companies and CROs.
Drug development outsourcing is an estimated 20 billion USD per year business, according to Outsource Magazine. Pharma companies allocate up to 50 percent of their budget for outsourcing strategies.
What is being outsourced?
Pharma companies outsource a considerable amount of clinical work including site monitoring. But analytical services like data management and study statistics are also increasingly outsourced. Strategic outsourcing now focuses on technology services as well. Technical services in laboratories and medical imaging are crucial for the clinical part, but the increase of “eClinical”
Full-service or Niche?
With the adoption of the strategic-partnership model, drugmakers need to evaluate how to pick their partners. Ideally, pharma companies are looking for a long term relationship with a CRO, a partnership built on trust and quality results. Morningstar reports that this type of partnership model has been key to CRO success and growth.
However, outsourcing strategies have inevitably become more complex. Regulatory authorities are holding CROs just as accountable for drug safety and data quality as their pharma partners. As Outsource Magazine reports, “measurement of quality in CRO deliverables is now a requirement in every outsourcing relationship”
The key strategy for drugmakers is to find CROs with an area of expertise.
One of the biggest concerns surrounding full-service CROs is poor project governance. There is a lack of clarity and communication throughout the different steps of the project. The “governance gap” can create problems when it comes to patient safety and data quality. Smaller CROs tend to be more flexible, pay more attention to quality and respond quicker to customer needs. To improve governance, an outsourcing strategy should include careful vendor selection in terms of quality, capabilities and expertise and cultural considerations.
Functional Service Outsourcing Strategy
This strategy is becoming increasingly more adopted in pharma outsourcing. CROs that specialize in bio-metrics and clinical trial management become FTE, or Full Time Equivalent– partners. According to the Clinical Research Society, functional outsourcing to local and niche CROs for data management is becoming the norm for outsourcing strategies. Another important consideration being taken by drugmakers is whether CROs are functional experts rather than simply clinical experts.
How has CROS NT adapted to this strategic partnership model? Being a CRO focused on biometric services, CROS NT intends to provide only the highest quality analytical services and form long term partnerships with pharma companies. Another strategy adapted in this past year for CROS NT has been the formation of partnerships with clinical CROs who are experts in the their field and geographic region to provide the ideal outsourcing package.
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CROS NT is a global functional service Contract Research Organisation with expertise in biostatistics and clinical data management, completing over 800 projects. The IT subsidiary, ARITHMOS, provides technology solutions – including ePRO and data integration–