Get an overview of IQVIA's full range of solutions to help you work more efficiently, standardize and improve controls across development stages and geographies.
Biopharma companies face significant complexity working in a global environment governed by rigorous regulatory and safety requirements that vary by market. Understanding and managing local regulatory requirements presents a significant burden. Few companies are able to fully maintain a current global regulatory intelligence database that captures all local variations and updates. Many companies struggle to maintain core data sheets, safety information and labels aligned globally. Likewise, few companies have fully scalable infrastructure to handle rapid increases in safety related activities and risk management. To effectively manage your portfolio, you need to do more than simply meet regulatory requirements. By aligning all aspects of marketed product maintenance, including regulatory, safety and benefit-risk management, you can improve compliance, and reduce complexity and cost.
To respond to the challenges of today’s healthcare environment — including growing regulatory, financial, development and regional pressures — biopharma companies must optimize resource allocations. While promising new products are an obvious place to invest, established marketed products cannot be ignored; as products age, the pressures to shrink maintenance costs and grow or maintain revenue continue to increase — all while ensuring regulatory compliance and reducing risk (Figure 1). These dynamics present unique challenges for managing established products and require innovative and cost-effective approaches that help ensure patient safety and compliance while continuing to meet ever-increasing regulatory demands.
Get an overview of IQVIA's full range of solutions to help you work more efficiently, standardize and improve controls across development stages and geographies.
Predict enrollment more accurately and increase the number of patients per site using data-driven patient recruitment solutions.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
Change the model of clinical research by integrating data, expertise, analytics and technology from study design through execution to power better decisions.
Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.