Delivering Real World Evidence... because clinical trials only get you so far
Medialis recognises the challenges of in-house delivery of medical affairs projects, offering a complete Intelligent End-to-End Medical Affairs delivery vehicle.
Medialis ensures the right strategic asset is generated for the right reason…communicated in the right way.scroll down
Real world evidence studies answer the question frequently asked by payors: ‘How do real patients perform on the medicine?’ This is in contrast to the randomised controlled trials, mandated by the regulatory bodies before a product is granted marketing authorisation, which are designed to answer the question: ‘Does the medicine work?’ The next question usually asked is: ‘How much more cost-effective is this medicine compared to the ones we already have?’
From Data to RWE
Successful RWE Generation, Medialis ensures the right strategic asset is generated for the right reason...communicated in the right way.
Generating the Optimal Quality of Evidence
Medialis will analyse your brand plan & create an integrated medical/KOL plan aligned to each CSF This includes defining strategic assets that need to be developed to meet them.
Real world evidence needs to answer a specific research question
As with randomised controlled trials, their construction needs to be exposed to the same rigour in their protocol writing, statistical analysis and planning, etc.
Medialis Medical Planning and the Multi-Stakeholder Approach
Learn how we can ensure that a medical plan is developed with the full engagement of all stakeholders.
Coordinating and collecting feedback in an efficient way to ensure the items included in the plan are agreed by the internal stakeholders can be a challenge.
Our approach involves using a novel group awareness and consensus methodology to generate and agree, the SWOT, Critical Success Factors (CSFs), Aspirational Statement before we go away and design the tactics themselves.
Medialis services include:
- Network Meta Analysis (NMA)
- Systematic Reviews
Data synthesis: Network Meta Analysis (NMA)
Head to head trials involving two or more interventions are expensive and time consuming. As such, they primarily serve a regulatory purpose and, where appropriate, are limited to placebo-controlled trials. However, the ‘which intervention is better?’ question remains.
The NMA is a better approach to use data in the public domain to model expected outcomes from two or more interventions. Recognised by NICE as a valid approach to understand these expected outcomes in the absence of head to head data, Medialis has vast experience in designing and executing these for publication in support of medical objectives.
Contract Research Organisation (CRO)
As a full CRO, Medialis can help you by providing you with significant results.
Medialis has helped and supported international companies to deliver the best services and products to the patients and the market in general.
Medialis is a full CRO:
- Patient registries and clinical trials management
- Qualitative research
Patient access to a medicine, post marketing authorisation, depends on increasing local and regional approval by drugs and therapeutics committees. Medialis has pioneered a specialised approach to:
- Patient characterisation
- Patient identification
- Patient information day
Medialis has vast experience in organizing Patient information days (PID) in UK and EU, ready to adapt and target different populations and therapeutic areas.
This specialised approach will enable industry stakeholders, patient groups and prescribers, to expand the access to medicines to a population that would experience a benefit.
Medialis are specialists in Qualitative research methods.
This allows patients to be interviewed and characterised in a way traditional randomised control trials or observational studies are not designed to do.
Rare diseases often have long lead-times to diagnosis, and patient outcomes can be poorer the longer patients are left untreated.
Medialis has designed variations of its patient identification programme to service orphan diseases as well as primary care.
The insights protocol extracts and highlights the relevant subjects to deliver a flawless project.
From clinical trials and registries planning and management to successful market access and communication strategy, the insights protocol can guide you all the way providing an accurate and deep understanding.