Application Notes & Case Studies

  1. Leveraging Medrio’s CloudEDC™ To Provide Large CRO-Style Service

    Unlike in the past, today’s small CROs specializing in distinct therapeutic areas are competing with their much larger counterparts. One reason for this change is the availability of CloudEDC™.

  2. How Medrio Helps PharPoint Achieve Phase I Success

    It is widely recognized within the pharmaceutical and medical device industries that there is a distinct competitive advantage that comes with being first to market.

  3. CUREM’s Use Of Medrio Allows For Study To Be Built Early And Under Budget

    CUREM Research Partners is a contract research organization (CRO) providing customized clinical trial research support including study management, clinical monitoring, and data management.

  4. How One CRO Uses CloudEDC™ To Expand Clinical Trials Services

    Ophthalmology research is a fast growing field of clinical research, and with roughly 3,000 open or active ophthalmology related trials, the need for CROs specializing in optimizing ophthalmology trials is growing with it.

  5. Observational Studies, Late-Stage Research, And Medrio

    Observational studies are becoming increasingly important as pharmaceutical and device companies compile evidence of the real world value of their products.

  6. Three Ways To Maximize Post Marketing Research For Biosimilars

    Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team is supporting a sponsor with a Phase IV study of a gastroenterology biosimilar. This late phase study has yielded three important lessons for biosimilar manufacturers.

  7. A Step Change In Study Startup Efficiency

    Study startup is one of the most challenging and costly stages of the clinical research life cycle. Recent statistics indicate that nearly 80% of studies fail to meet enrollment timelines, and up to 50% of research trial sites enroll one or no patients . At the same time, protocols are growing in complexity, competition for patients in oncology studies is on the rise, and increased regulatory requirements demand more of study teams. Recognizing these challenges, in 2012, a US Monitoring Operations organization made an investment in study startup.

  8. Clinical Supply Optimization: Building Trust To Ensure Patient Safety

    Fisher Clinical Services was contacted in early 2013 by a virtual biotech that had a set of unique challenges. With just one compound in the pipeline, the company was in trouble because its previous vendor made drug supply errors that compromised patient safety in Phase II. Not only was the clinical team navigating the ethics investigation triggered by this violation of trust, the legal team was fending off lawsuits from investors.

  9. The Critical Importance Of Comparator Temperature Excursion Management

    Today, comparator procurement is one of the most expensive components of clinical trials. This cost can take on further meaning as the risk of a temperature excursion or a loss of drug due to time out of environment can result in additional charges and even delays in the trial.

  10. Quality Of Recruited Patients Vs. In-Practice Patients

    Clinical trial data are the lifeblood of every submission, and it’s no wonder that clinical trial teams might be wary of trial participants who are not sourced by the research sites themselves. So the question is: Is there a difference in quality between externally recruited and in-practice patients? We have analyzed the data and the results are in.