From the FDA to the top 20 global biopharmaceutical companies, service providers, and care givers everyone is searching for ways to improve process, procedures, and margins. No one is spared from the impact of our economic situation today and the market is demanding greater focus on quality and safety, which is bringing the cost of drug development to record highs. Pharmaceutical, biotechnology, and medical-device companies are seeking alternatives to the traditional paradigm of full-service clinical trial outsourcing to maintain appropriate levels of control that lower their overall drug development costs. Many of these companies have completed process re-engineering in an attempt to lower costs only to realize that the true key to quality and timely delivery of clinical development projects is access to highly qualified people and the ability to coordinate and manage them. Outsourcing Models There are many different outsourcing tactics to meet clinical development needs, including straight clinical staff augmentation, dedicated resource teams, functional services, and full-service clinical trials. These tactics are each useful for meeting different needs of a company. The traditional full-service model greatly reduces the sponsor’s control of a project while maximizing the ability to hold a provider accountable for delivery, however, project quality and timeliness are not always in sync with total spend on the project. Dedicated resource teams or hybrid service solutions are being used more for consistent project support. These models are very useful for those sponsors seeking to reduce their infrastructure costs while maintaining a greater degree of control over project quality and timely delivery. Neither pharmaceutical, biotechnology, nor medical-device companies can rely on one outsourcing strategy and expect the highest degree of efficiency. Nor can they utilize different tactics through different outsourcing groups and expect to find efficiencies. Additionally, multiple providers are often hired to meet all outsourcing needs that must then be coordinated by each project manager or group head. Therefore cost-savings that were expected from outsourcing are not realized due to lack of communication, coordination, and experience from the different provider groups. Adaptive Models The growing popularity of utilizing flexible service providers has greatly increased the comfort level of sponsor staff by allowing the sponsor to set the level of control for each project. Today, there are many viable alternatives to the traditional model that ensure that both flexibility and quality are delivered. The results are a reduction in the sponsor’s infrastructure — systems, processes, management — and improved margin contribution and efficiency gains. The ability to consistently deliver on these high expectations is driven by the service provider’s business model. A flexible, integrated outsourcing model allows sponsor companies to select the service they need at a particular time and then be able to adapt quickly to meet the changing needs without having to change providers. Having a provider that is able to build the solution that fits as a sponsor’s needs change is paramount to delivering on the significant needs of today’s pharmaceutical, biotechnology, and medical-device companies. n Staff Augmentation Staffed Groups Strategic Resource Groups Functional Projects Full-Service Clinical Trials Therapeutic/Functional BPO Fully Integrated Partnership Stephen O. Cottrell, Executive VP, Operations and Business Development Adapting to Meet Today’s Needs inVentiv Clinical Solutions inVentiv Clinical Solutions, as a strategic partner, provides comprehensive and flexible clinical development services built to FIT your specific needs, complimented by industry-leading contract staffing capabilities.. As a division of inVentiv Health Inc. (NASDAQ: VTIV), we also leverage expertise from clinical to communications and commercialization to build cutting edge solutions. For more information, visit inventivclinical.com.
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Adapting to Meet Today's Needs
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