IQVIA Biotech Thought Leadership

  1. Navigating An Evolving Global Regulatory Landscape 8/19/2021

    Our regulatory experts are closely following the evolution of regulatory guidance on COVID-19 and the approach taken by global regulatory agencies.

  2. The Nuances Of Hematologic Oncology Clinical Trials 7/26/2021

    This paper examines the requirements for effectively and successfully conducting hematologic oncology clinical trials.

  3. Going Virtual: Yes, Oncology Trials Can Do It Too 8/19/2021

    How do patients receive necessary continued care when there is limited or no access to providers or trial sites? With the risk of exposure to COVID-19, will immunocompromised patients be safe to participate in trials in the traditional sense now and in the future?

  4. Natural History Studies For Rare Diseases: Development Strategies For External Comparator Arms Leveraging Real World Insights 7/26/2021

    This paper explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.

  5. Partnering Solutions For Emerging Biopharma 7/26/2021

    This paper is the first part of a series of articles aimed at helping the EBP team better assess the value of a “partnered” outsourcing approach across the continuum of development and commercialization, and potential approaches to mapping out the right fit for their organizational needs.

  6. Future Forward View For Biotech Companies 7/26/2021

    The pandemic has forced the biotech industry to quickly adapt and, as a result, is fueling the modernization of clinical trials. This article will review the biotech perspective of modern clinical trials and explore what the next normal may look like.

  7. Helping Non-U.S. Based Biotechs Navigate Entry Into The U.S. Clinical Development Market 8/19/2021

    Increasingly, non-U.S. based companies are looking to bring their innovative investigational products to the U.S. for clinical development. Clearing the U.S. FDA not only ensures access to the largest market but also may provide a smoother path to marketing approval in other countries and markets.

  8. Capturing The Attention Of Investors: Create A Compelling Value Story 6/28/2019

    While demonstrating the value of a product is important for any organization, it’s critical to convey to investors that the drug candidate has the potential to meet the unmet needs of patients today and tomorrow. Explore three key components to creating a compelling value story.

  9. Moving Forward In Immuno-Dermatology: Clinical Trial Considerations 8/19/2021

    The global commercial dermatology market is estimated to reach $33.7 billion by 2022. With this momentum and the continued need for safe and effective dermatology treatments, it’s important to understand the strategic needs of clinical trials using novel immuno-dermatology agents.

  10. Embracing Innovative Designs In Early Phase Oncology Trials 6/28/2019

    Advancements in science and technology, combined with unmet patient needs, are driving accelerated timelines and creative pathways for oncology drug development.