White Papers

  1. Real World Evidence Generation: The Value Of Cross-Sectional Studies, Medical Chart Reviews And Hybrid Designs

    Cross-sectional studies (CSS) serve as an effective study design option to gather pertinent epidemiological data quickly to support drug development across the lifecycle. Here we explore how a hybrid MCR combined CSS can be an advantageous study design for real world evidence (RWE) generation, and how gaining a better understanding of the implementation of these designs can allow for better future planning, as well as to guide the development of the next generation of real world studies.

  2. Navigating The Challenges And Opportunities Of Value Based Health Care

    The rapid shift to VBHC is reshaping markets for medical and diagnostic devices in several important ways. Its incentives significantly affect the purchasing behavior of payers, clinicians and patients – and what device makers must do to win their business. Generally, this includes determining how these various stakeholders define value, and gathering evidence to build a value based purchasing case early in the product development cycle. In this paper, we examine some of the major factors that influence how different stakeholders define value. We then describe a model for mapping stakeholder value that can help drive profitable device development programs in increasingly value driven markets.

  3. Making Sense Of The Biosimilars Market - Strategies And Recommendations To Achieve Optimal Market Access

    Biosimilars are generally expected to offer a competitive price advantage to appeal to healthcare organizations and payers which make them an attractive business opportunity.. This whitepaper provides an introduction into key regulatory and development concerns for sponsors, including a discussion of the factors that affect biosimilar uptake for the United States and Europe and recommendations to address these issues

  4. Clinical Trial Disclosure Management: Build vs. Buy

    The big challenge for study sponsors is that clinical trial transparency remains a “volatile” area with continuously evolving requirements and expectations. Most life sciences companies don’t have the time, money or resources to develop a compliance solution.

  5. Emerging Pharmaco’s Dilemma: Make A Deal...Or Not?

    Take a closer look at funding strategies for companies launching products for the first time. Does partnering or "Going it Alone" make more sense for emerging companies? Read the findings of a 2006-2015 analysis, including implications for research companies, their potential large pharma commercialization partners, and venture capitalists.

  6. Embracing Innovative Designs In Early Phase Oncology Trials

    Advancements in science and technology are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and regulators seek new ways to efficiently move promising therapies from the clinic to approval – embracing a streamlined path that bypasses the traditional development paradigm of standalone sequential Phase I/II/III trials.

  7. Partnering Solutions For Emerging Biopharma: Alternative Outsourcing Strategies

    In an increasingly complex drug development and healthcare environment, it is extremely important for companies to be able to demonstrate value, even if their intention is to be acquired or to out-license their asset following proof-of-concept. Learn more about partnering solutions available to small and emerging biotech companies.

  8. Capturing The Attention Of Investors: Create A Compelling Value Story

    While demonstrating the value of a product is important for any organization, the pressure is more acute for small and emerging biotech companies. It’s critical to convey to investors that your drug candidate has the potential to meet the unmet needs of patients today and tomorrow. Explore 3 key components to creating a compelling value story.

  9. IRT Is NOT A Commodity: Topics To Discuss With Your Vendor

    With so many different systems available, how do you decide which one is right for your study? This paper will help you match system and vendor capabilities with the unique requirements of your trial.

  10. 3 Strategies For Integrating Flexibility Into Clinical Supply Chain Planning

    Sometimes, clinical trials do not succeed because of incomplete planning and a lack of contingencies for when circumstances change. So, how do you plan for unanticipated obstacles that may affect the clinical supply chain and, ultimately, the outcome of your trial?