White Papers

  1. Gene Therapies In Rare Disease: From R&D To Regulatory Approval
    5/16/2019

    Advancements in science and technology have helped researchers develop new treatments for some of the most common diseases known to man. For rare diseases, however, patients have limited treatment options. Advocacy groups and regulatory authorities continue to encourage rare disease research, and more and more scientists are stepping up to the task.

  2. Bringing Real World Evidence Into Clinical Research
    5/15/2019

    Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

  3. Confronting The Challenges Of Rare Disease
    5/14/2019

    This paper is intended as a discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.

  4. 5 Critical Steps In Developing Your Clinical Supply Chain
    5/10/2019

    Clinical supply chain planning is imperative, as it allows you to develop a strategy and best practices for quickly and efficiently delivering goods to support all the needs of the trial. But, where do you begin?

  5. Not Like Everyone Else: Unique Challenges For Small And Emerging Biopharma Companies
    5/7/2019

    Small and emerging biopharma companies are conducting almost 50% of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams, and solutions that can reduce the pressure on teams and timelines.

  6. Compensating Participants In Clinical Research: Current Thinking
    5/7/2019

    New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants.

  7. Removing Barriers: Reimbursement And Compensation For Participation In Oncology Clinical Trials
    5/7/2019

    Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.

  8. Key Findings From The EMA’s Qualification Opinion On DDC
    4/29/2019

    The EMA’s qualification opinion on Direct Data Capture (DDC) is a huge regulatory development for the clinical research industry. Read our white paper for a quick understanding of the major points in the opinion, and of how DDC improves data accuracy, monitoring, and more.

  9. Unpicking The Complexity Of Importer Of Record Processes In Globalized Clinical Supply Chains
    4/26/2019

    A competent Importer of Record is a prerequisite to any successful global clinical trial. The role is vast and the remit wide, covering everything from ensuring imported goods comply with local law and regulations, payment of import duties, tariffs and fees; to risk mitigation and maximizing opportunities to ensure the right drug, gets to the right patient at the right time.

  10. Advanced Analytics For The Monitoring Of Clinical Trials
    4/26/2019

    Clinical research generates a massive amount of data. Unfortunately, because of the way most clinical data programs currently work, much of these data are not used to their fullest extent; they are simply filed away. This white paper will focus on the benefits provided by a unique and advanced analytical approach to study monitoring beyond the minimum necessary RBM approach.