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Medialis can get more patients on your new medicine sooner

Using our 30/22 Strategy to generate Stakeholder-targeted RWE.
Getting wrong or incomplete answers to efficacy, safety and Quality of Life measurements Risking patients not receiving medicines they would benefit from Risking patients receiving medicines far later than necessary
Defines accuracy of an observation againstit’s ‘true’ value, observed with Neutrality True value is observed using a Neutral list of indicators In clinical studies, the Neutral list for apatient is the diseasephenotype

Consensus based LIST-generating methodology. Which can operationalise Neutral Theory in developing Neutral lists of indicators for any construct

Need to satisfy 3 gatekeeper stakeholders: Regulator, Payor and Prescriber all have different real-world evidence needs, Pharma is currently mismatched with them

30/22 Strategy RWE and RCTE at regulatory submission increases depth of maximal adoption by 30% and shortens time maximal adoption by 22% Regulatory subsystem controls depth of max adoption via the indicatable population they receive evidence for Prescriber controls time to max adoption via the volume of experience in the real world

A novel method for observing proportional group awareness and consensus of items arising from list-generating questioning

A good real-world evidence medical plan can make or break the development and adoption of new medicines.

A novel group awareness and consensus method (Jandhyala 2020) is used to develop the medical plan.

This engages all the internal stakeholders relevant to the commercialisation of a medicine ensuring all external stakeholders’ needs are recognised and accommodated in the development of the critical success factors and aspirational statements.

Insight on the Jandhyala Method

At Medialis, we use the Jandhyala method to answer list-generating questions, especially those that enhance the accuracy of measures used to observe constructs in clinical studies and trials.

This method of observing proportional group awareness and consensus consists of two rounds of questionnaires. The first survey consists of an open-ended question for the experts to answer. Answers can be used to generate an item list and assess the awareness of the experts of a particular subject; it also allows the awareness of items to be recorded in an unprompted way. The structured questionnaire generated from the items identified during the first round can also have items added to it by the investigator(s).

As such, the process of observing proportional group awareness and consensus is flexible, allowing the input of results from literature searches into the structured questionnaire in Round 2, thus providing the participants the benefit of reviewing items that may not have been suggested in their first round.

Improving the match between pharmaceutical company and regulator indicators to provide the best evidence, right from the start

By improving the accuracy of construct measurement in clinical studies and aligning patient registry indicators with regulator needs, we help pharmaceutical companies provide regulators with vital information to enhance decision-making and ensure that the right patients are indicated for treatment at the right stage of their disease.

We are committed to exploring the benefits of generating real-world evidence early enough to include in regulatory submissions, for both medical affairs and commercial organisations

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Medialis is a medical affairs consultancy servicing the pharmaceutical industry. Unlike some other agencies, we are proactive, not reactive or one-dimensional - if you need it, we can do it.

Medialis is a medical affairs consultancy servicing the pharmaceutical industry. Unlike some other agencies, we are proactive, not reactive or one-dimensional – if you need it, we can do it.