Application Notes & Case Studies

  1. Avoid Wasted Trials: One Story Of An Estimated $100M Saved

    The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – like genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.

  2. Modular Bioprocess Platform Gives CMO Maximum Flexibility

    Pharmaceutical companies are increasingly outsourcing product production to contract manufacturing organizations (CMOs). Doing so enables them to focus more of their resources on developing innovative new products and less on non-core, commodity activities, such as manufacturing. While this has been a boon for CMOs, it also creates new challenges as both their client base and related production demands rapidly diversify. Just staying on top of it all can be a big job.

  3. A Comprehensive Named Patient Programme (NPP) That’s Adaptable To Expansion

    Challenge: A biotech company launched a Named Patient Programme (NPP) that required complex and dedicated operational support. The NPP demanded expedited patient eligibility review and urgent drug shipment to an extremely sick patient population. High patient demand from a global population encouraged them to seek a pharma services provider to manage the programme.

  4. A Competitive Race: Accelerating The Development Timeline With A Multi-Trial IRT Programme

    Time is always of the essence in clinical trials. But when competitors have the lead in bringing an alternative therapy to market, “the need for speed” takes on a whole new focus. This was the case with one top tier global pharmaceutical company that was just beginning its development program for several infectious disease indications.

  5. Supplying Costly Investigational Product: Pre-Randomisation Approach Reduces Drug Wastage

    Certainly, every sponsor wants to minimize wastage in clinical trial supplies, but the motivation to do so is extraordinary when the product under study is unusually expensive. A top-tier, international pharmaceutical company engaged Almac to ensure that it did not incur undue drug supply costs for a global study involving a very expensive investigational product. With some ingenuity and customisations to the IXRS® platform for managing patients, supplies, and trial data, Almac helped the client re-envision its study design and supply strategy.

  6. Smart Start-Up: Combining Streamlined Processes & Leading Edge Technology

    A leading global contract research organization was contracted to conduct a two phase global oncology trial on behalf of a mid-sized Pharma company. The study was comprised of both phase I (dose finding and dose confirmation) and phase II (dose expansion) components. The original goal was to activate 20-25 sites for the phase I component and an additional 55 sites to be on boarded for phase II. By the time the protocol was received, sites had been selected and the First Site Initiation Visit (FSIV) was targeted to occur in less than five months. The core regulatory pack was due for finalization within 11 days of receipt of the protocol.

  7. Medrio Makes Your Clinical Study Build Easy, Even For New Data Managers

    It’s not often that two clinical data managers who are years apart in their experience feel equally at ease during a clinical trial. But this is precisely what took place at Ancillarie, a support services company that has been serving pharmaceutical and biotechnology companies since 2012. In 2013, seeking an electronic data capture (EDC) system to catalyze their clinical research, they began a collaborative relationship with Medrio. Since then, they have conducted three clinical trials using Medrio’s software – all dermatology studies. Over the course of those studies, both veteran and early-career data managers at Ancillarie have found Medrio’s software to be convenient and user-friendly, and have achieved comparable efficiency in their research.

  8. Efficient Mid-Study Changes: A Case Study With DataFlex

    DataFlex Solutions, a contract research organization (CRO), uses a dynamic, flexible, remote based model with efficient use of standards and cutting edge reporting tools to provide cost effective and innovative solutions to clients.

  9. 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™.

  10. 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.