艾昆纬-为中型制药公司提供综合药物开发、监管战略和人工智能创新（英）

White PaperEmpowering Mid-size Pharma Companies with Integrated Drug Development, Regulatory Strategy, and AI InnovationMICHELLE GYZEN, Senior Director of Strategic Regulatory Solutions, IQVIA BRIAN HEALEY, Global Head of Drug Development and Regulatory Strategy, IQVIA CLAIRE DAVIES, Senior Director, Regulatory Affairs, IQVIATable of contentsIntroduction 1The consultative, end-to-end CRO model 2A robust regulatory approach 3The strategic role of AI in mid-size pharma companies 4An IQVIA customer success story 4Secure your competitive advantage 4About the authors 5About IQVIA 5 iqvia.com | 1Mid-size pharma companies sit at a distinct intersection in the current pharmaceutical landscape. While their teams have the agility to innovate quickly, they may lack the scale, infrastructure, and resources of larger companies, creating both risk and opportunity. Without robust support, promising assets can stall, compliance gaps can emerge, and valuable market opportunities will fall by the wayside. However, with the right CRO partner, these organizations can convert high potential into speed-to-market. Though many mid-size organizations may avoid the CRO route for fear of high costs, loss of control, or insufficient support, a strategic partnership can be activated to mitigate these concerns and transform potential challenges into advantages. A consultative, tech-enabled CRO can help small to mid-size pharma companies achieve their targets by supplementing their skillsets, expanding their global reach and infrastructure, magnifying their expertise, and designing an effective clinical, regulatory, and operational strategy. IntroductionA consultative, tech-enabled CRO can help small to mid-size pharma companies achieve their targets.2 | Empowering Mid-size Pharma Companies with Integrated Drug Development, Regulatory Strategy, and AI InnovationThe consultative, end-to-end CRO model Given the unique qualities of small to mid-size pharma companies, these organizations need an experienced and adaptable partner that offers end-to-end services, aligning clinical and regulatory functions with strategic technical innovation while saving money and increasing synergy. Global reach and flexibility are both imperative in a chosen partner.So, what does an end-to-end model look like in practice? First and foremost, companies will have access to a team of experts to interact with across every stage of the product lifecycle. Drug development, clinical, bioanalytical, and regulatory solutions should collaborate seamlessly across functions to provide scientific, medical, and operational support. For mid-size companies without the existing infrastructure to accommodate every clinical development and lifecycle management component, CRO support is a major value add.Each company has distinct needs. Because of this, it is critical to collaborate with a CRO that offers a flexible model in which services can be adapted to suit customer goals. A CRO with previous mid-