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Medialis Ltd is thrilled to announce the completion of our first proprietary software application: JeMa (Jandhyala Method Application). This app enables us to seamlessly administer the #JandhyalaMethod, shortening the time to delivery of the completed research for our clients considerably. Incorporating our own state-of-the-art AI, JeMa will enable Medialis to further develop our algorithms to...
We Medialis Ltd are celebrating the end of another successful year as the only #medicalaffairs consultancy and CRO. We showed why our unique approach matters in seven key research projects in 2021. Our work in 2021 on the four pillars showed how #medical affairs enhances #rwegeneration and strategy for #pharmaceuticalcompanies. With increasing payor and...
This work, carried out by Medialis, is the first study to estimate the impact of egg-adaptations on #influenzavaccine effectiveness. Our experts agreed that compared to TIVs and QIVs, avoiding egg-adaptations could improve #influenza #vaccineeffectiveness by up to 16%, suggesting that new technologies that avoid egg-based manufacture could deliver increased benefit to patients. We used the...
Background X-linked hypophosphatemia (XLH) is an inherited disease of phosphate metabolism in which inactivating mutations of the Phosphate Regulating Endopeptidase Homolog, X-Linked (PHEX) gene lead to local and systemic effects including impaired growth, rickets, osteomalacia, bone abnormalities, bone pain, spontaneous dental abscesses, hearing difficulties, enthesopathy, osteoarthritis, and muscular dysfunction. Patients with XLH present with elevated levels of...
Background A pilot study conducted in 2020 suggested that Medical Affairs Pharmaceutical Physicians (MAPPs) may be inherently undervalued within the pharmaceutical industry and vulnerable to replacement by less qualified roles. There are currently no standardized metrics to measure MAPP performance, thus it is necessary to measure the value of MAPPs to employers and clarify the...
Background The novel coronavirus (SARS-CoV-2) has led to a global pandemic, resulting in a disease termed COVID-19, which commonly presents in adults as a typical infection of the upper respiratory tract. Although the disease is often acute, one in ten patients can continue to be affected for weeks or months, resulting in a state called...
Background In 2020, the European Medicines Agency (EMA) published EMA Regulatory Science to 2025, which included among its top five core recommendations the promotion of the use of high-quality real-world data in regulatory decision making [1]. The OPTIMAL framework is a set of criteria developed by the EMA for the regulatory use of RWE, which...
We Medialis Ltd are pleased to announce our latest workshop, How to Generate RWE for Regulators, Payors, Prescribers and Patients, launching online in 2022. As part of this value-packed #traininganddevelopment event, you will discover : – How to optimise the adoption of your new #medicine by generating high quality #RWE tailored to #stakeholderengagement needs –...
Background: There is currently no standard definition of medical affairs, despite its increasing importance to the pharmaceutical industry. The evolution of medical affairs necessitated the development of a standardised definition to guide policy and practice to ensure that patients’ interests remain central amid shifts that have, in the past, created fertile ground for ethical violations....
We’re celebrating a birthday here at @medialis: the #jandhyalamethod is 2 years old today. Published online in 2020, it has been used to delivered 6 important pieces of original research in #medicalaffairs and #realworldevidence in #rarediseases and a broader #construct measurement. In delivering the first disease-specific #qol instrument for #longcovid, the #jandhyalamethod operationalised #neutraltheory to...