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  Introduction The optimal launch and adoption of novel medicines require effective navigation of the commercial and regulatory landscape, including three key gatekeeper groups: regulators, payors, and prescribers. Traditionally, despite lacking generalisability, the pharmaceutical industry provides Phase III randomized controlled trial evidence to gatekeepers. Despite additional real-world evidence (RWE) improving the generalisability of evidence, the...

We Medialis Ltd are pleased to share with you the third of a series of updates on the principles underlying our work, the four pillars of our medical #thirty22 #realworldevidence strategy. Pillar 3 of our strategy focuses on the application of the #multiplestakeholderapproach to #realworldevidence generation for #clinicalstudies. Our research showed that stakeholder groups have...

jandhyala method

We @Medialis Ltd are pleased to share with you the second 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 2 of our strategy focuses on the application of #Neutraltheory via the #Jandhyalamethod to observe #consensusopinion from #keyopinionleaders...

Jandhyala method

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...

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...

key findings medical affairs

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...

vaccines

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...

mapp

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...

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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...

Jandhyala method

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...