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In early 2020, as the COVID-19 pandemic reshaped our world, Medialis Ltd recognised the urgent need for a disease-specific quality of life (QoL) instrument for long COVID patients. This, led to the development of the PAC-19QoL. Rapid Development Timeline: We received ethical approval in October 2020 and initiated the development of the PAC-19QoL on November...
Medialis Ltd is proud to present our latest publication: “Real-world service cost’s for neovascular-AMD clinics in the United Kingdom: Structured literature review and scenario analysis” in Current Medical Research & Opinions Real-world Evidence section Key Highlights: Innovative Use of Neutral Theory & Jandhyala Method: We leveraged these advanced methodologies to develop the nAMD Service Non-Drug...
Introduction Low rates of inclusion of real-world evidence (RWE) during regulation may arise from lack of clarity and consensus on its definition. A conceptually mature definition of RWE may have pragmatic utility, increasing its inclusion during regulation. The aim was to develop a definition of RWE to promote inclusion in regulatory submissions and assess...
We @Medialis Ltd are pleased to share the first of a series of updates on the #medicalaffairs principles underlying our work, the four pillars of our medical #thirty22RWEstrategy in the #pharmaceuticalindustry, #rarediseases and #orphandrugs. Pillar 1 of our strategy focuses on the application of #Neutraltheory to #constructmeasurement problems in #clinicaltrials and #clinicalstudies. #Neutral theory allows...
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...