Insights On Trial Design

  1. When It Comes To Your Patient Adherence (Compliance) Strategy, Think Training

    Sponsors deal with myriad considerations in how to reduce overall risk and costs across a study, but managing the complexity of patient behavior must always stay in focus. The challenge of patient treatment adherence and retention can do a lot more than create delays and increase expenses during a clinical trial. When a patient does not comply with the treatment regimen, the integrity of the clinical trial data is at stake, and patient safety is at risk. Read how a compliance-focused LMS can positively impact patient compliance during a clinical trial.

  2. 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.

  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. Midlantic Urology Associates Introduces Added Convenience For Patients With Rideshare Program

    Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.

  5. Complementing ePRO + eCOA Platforms With Patient Micropayments

    Sadly, the average drop-out rate across clinical trials is 30%. Greenphire has increasingly seen clients focused on increasing completion rates of patient reported outcomes and bolstering compliance using ClinCard. ClinCard has built-in text reminders for upcoming onsite patient visits and the ability to trigger “micropayments” when select tasks are completed.

  6. Critical Milestones Achieved Ahead Of Schedule In Lung Cancer Study

    Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.

  7. 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.

  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. 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?

  10. Spotlight On Quality In Study Startup

    This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.