32 June 20 08 VIEW on Clinical Operations OUTSOURCING I t’s no secret that outsourcing processes are constantly changing based on industry needs and regulatory require ments. Additionally, workflow reengineering is occurring in every corner of the industry, from the FDA to the top 20 global biophar maceutical companies. New regula tions call for increased scrutiny in clinical trial data, demanding greater focus on quality and safety bringing the cost of drug development to record highs. Biopharmaceutical companies must seek out alternatives to the traditional paradigm of fullservice clinical trial outsourcing to main tain appropriate levels of control that lower their overall drug development costs. Many of these companies have completed pro cess reengineering to try to lower costs but then realize that the true key to quality and timely delivery of clinical development pro jects is having access to highly qualified people and the ability to coordinate and manage them. Outsourcing Tactics There are different outsourcing tactics to meet clinical devel opment needs, including straight clinical staff augmentation, dedi cated resource teams, functional services, and fullservice clinical trials.These tactics are each useful for meeting different needs of a company. Many companies utilize fullservice clinical providers to meet their outsourcing needs.The traditional fullservice solutions 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 is not always in sync with total spend on the project. Dedicated resource teams are seeing more use for consistent project support as these teams can be modeled to meet specific needs and are very useful for those sponsors seeking to reduce their infrastructure costs while main taining a greater degree of control over project quality and timely delivery. Pharma, biotech, or medicaldevice companies can rely neither on one outsourcing tactic and expect the highest degree of effi ciency, nor can they utilize different tactics through different out sourcing groups and expect to find efficiencies. Additionally, multiple providers are often hired to meet all out sourcing needs that must then be coordinated by each project manager or group head.Therefore cost savings that were expect ed from outsourcing are not realized due to lack of communica tion, coordination, and experience from the different provider groups. Benefits of Flexible Models A flexible provider can greatly increase the comfort level of sponsor staff with new sourcing efforts by allowing the sponsor to set the level of control for each project, which allows the sponsor and provider to develop a level of comfort with each other. A flex ible provider allows the sponsor to manage a single or limited num ber of provider relationships reducing the sponsor’s oversight team as well as ensuring the flexibility to use the perfect sourcing tactic for each type of clinical development work depending on the com plexity and comfort level of the sponsor staff. In addition, a flexible provider can work with a sponsor to mutually reduce a sponsor’s infrastructure (systems, processes, management) over time as the sourcing relationship grows. A flexible, integrated outsourcing model allows the proper blend of tactics for current development needs that can be adapt ed quickly to meet the changing needs of the organization and the industry. Having a provider that is able to migrate across the continuum as a sponsor’s needs change is key to a truly flexible and efficient outsourcing solution. # INVENTIV CLINICAL SOLUTIONS, Houston, provides unique clinical outsourcing solutions, allowing the greatest flexibility through unmatched access to high quality clinical resources. For more information, visit inventivclinical.com. Flexibility & Agility The New Outsourcing Paradigm Todd Fears, Senior Director, Clinical Project Management The Flexibility Continuum Maximum Sponsor Control Executive Internally Minimum Sponsor Control Fully Outsourced Maintaining desired level of control with significant flexibility and costeffectiveness Staff Augmentation Resource Teams Functional Services FullService Solutions inVentiv Clinical Solutions 0608 pvv layout FINAL 5/29/08 11:44 PM Page 32 Results… accelerate Contact us today at: P: 800.797.8287 [email protected] www.inventivclinical.com Find out how inVentiv Clinical can provide the control and flexibility you need to accelerate your clinical trial results! …with unmatched access to the highest quality clinical resources! Clinical Development Solutions Including clinical trial management, monitoring, data management, biostatistics, medical writing and regulatory affairs Strategic Resource Groups Custombuilt teams for access to longerterm relationships with researchcritical personnel while avoiding coemployment issues Contract Staffing Clinical and scientific contract staffing solutions through our industryleading staffing divisions, MedFocus and Smith Hanley Consulting Group Visit us at Booth #817 01597_vencls_race_DIA_program_ad1 1 3/18/08 5:29:31 PM

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