White Papers

  1. A Blueprint for Building a Successful Plain Language Summaries Program 5/29/2020

    Whether you’re a sponsor reviewing an existing plain language summaries program or just starting from scratch, this PLS Planning Guide contains practical tips and best practices, from regulatory requirements to team roles and timelines.

  2. GI Trials With Novel Services And Technology 5/29/2020

    Current trial solutions rely heavily on electronic clinical outcome assessments (eCOA) to improve data quality and integrity. Eligibility decisions based on data  derived through calculations based on compliance and complex scoring are increasingly common. Further, the accelerating complexity of GI protocols has far outpaced the eCOA industry in simplifying trial solutions for that complexity. This paper describes the complexity of GI trials in detail and shows a solution that is designed to overcome their significant, but typical, challenges.

  3. COVID-19 And Clinical Trials: The Medidata Perspective 5/22/2020

    Medidata is continuously monitoring the global impact of COVID-19 on clinical trials. In this paper see the impact of COVID-19 on patients, trials, read about the regulatory response, and learn about solutions available to assist sponsors/partners, patients and trials.

  4. Reducing Site Workload For Better, Faster, Safer Clinical Trials 5/6/2020

    Life science companies are under increasing pressure to execute clinical trials faster with higher quality.  Read survey results that show as the Lumenis platform adoption increased, study teams began to see an improvement in data quality, operational efficiency, and ease of use compared to traditional paper and EDC methods.

  5. Creating Patient-Centric Supply Chains With Just In Time Manufacturing 5/5/2020

    As sponsors adapt to the rapidly developing COVID-19 landscape, there is a need to ensure patients remain at the heart of supply chain operations. Learn how Just in Time Manufacturing is one way sponsors can embrace patient centricity, while effectively redesigning supply chains to respond to the additional challenges presented by the ongoing global pandemic.

  6. Guidance For Remote Monitoring For Sponsors And CROs 5/1/2020

    Guidance for implementing remote monitoring as a broad policy at the site level. In light of COVID-19, Veeva proposes that sites and sponsors take a risk-based approach to updating policies and study documents to include only critical elements needed in order to implement remote monitoring quickly while not introducing administrative burden on teams.

  7. Successful Wearable Device Selection For The Evolving Clinical Trials Landscape 4/28/2020

    The number of wearable, connected medical devices (wearable devices) available for use in healthcare and clinical research has increased significantly over the past few years, making it difficult for clinical trial sponsors to determine
    which devices to use in their clinical trials. This white paper is an introduction to the emerging adoption of wearables in clinical trials.

  8. ChromoReport Winter 2019: Proactive Planning With Predictive Analytics 4/21/2020

    Complexity in clinical trials continues to grow a confluence of globalization, outsourcing, protocol complexities and ever-increasing regulatory mandates. The preliminary step of all clinical trials is study startup, which is widely recognized as a costly and perpetual bottleneck. Today have web-based maps that are always up-to-date and supplemented with satellite images and crowd-sourced, real-time information. What if you had this kind of navigation for study startup?

  9. The State Of Cell Therapies In Dermatology 4/21/2020

    Of the many types of skin stem cells that have been identified, epidermal stem cells — primarily keratinocyte stem cells — are recognized to play a key role in tissue repair and skin regeneration. These cells have been characterized as rare, infrequently dividing, and capable of generating the short-lived, rapidly dividing cells involved in regenerating the epidermis and repairing skin injury. This article discusses the challenges of developing cell-based therapies in dermatology.

  10. Understanding New FDA Guidance For Pediatric Oncology Studies 4/21/2020

    The Research to Accelerate Cures and Equity (RACE) for Children Act requires that any original new drug or biologics license application submitted on or after August 18, 2020, for a new active ingredient must contain reports of molecularly targeted pediatric cancer investigations if the drug is directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer. Learn more about the changes in this article.