Real World Evidence is becoming one of the drivers for several stakeholders working within the health system: pharmaceutical industry, regulatory authorities, clinical-scientific community, scientific associations, patient associations, patients and medical device manufacturers who are required to demonstrate and make decision about drugs in development on already on the market.
REAL WORLD EVIDENCE
Real-World Evidence: the new strategic lever
RWE is a methodology to support and complement information from experimental research; it is a tool to generate additional information useful to making decision
RWE IN A NUTSHELL
Extract more details and long-term evidence in a less selected population and closer to reality
Real World Evidence analyzes and crosses large amounts of data, no longer referring only to randomized clinical trials but inherent in routine clinical practice. The information generated can help different interlocutors to make decisions by optimizing processes, budgets and above all to make decisions about the patient’s health.
Real World Data (RWD) can have different applications if used and analyzed with the correct methodology. They can be used to support the creation of drawings of innovative experimental studies and analyzed to create relevant information to be able to make decisions on a pharmacutical technology, from different perspectives and at different stages of the life cycle.
DOCUMENTING VALUE: A SUPPORT FOR STRATEGIC DECISION
Improves the go-to-market of the drug, facilitates the adoption of the pharmaceutical product
Alongside initial research and product development programmes related to clinical trials, the growing demand for evidence and evidence of benefits and risks from the real world from decision-makers and the different stakeholders of pharmaceutical companies, promotes the use of Real Word Evidence protocols.
Up-to-date information on the safety and performance of medicines already on the market, but also all relevant information identified prior to the marketing of the same, They redefine and demonstrate the value in negotiations and influence the decision-making process in the field of health care, which is based on the effectiveness demonstrated in the real world.
They are useful for patients, for financiers, for those in charge of health services and for society as a whole, while they represent an indispensable plus to confirm and reshape the market strategy, in all phases of the life cycle of a product.
REAL WORLD EVIDENCE PROJECTS
From planning to executing projects using Real World Data
In Real Word Evidence projects, the multidisciplinary team of experts and consultants is able to facilitate and support you at all stages from the identification of the “need” business to the translation of the same in a solution adapted to the identified needs . (Planning, execution and strategy of generation of the information).
Using data and inputs from clinical practice, it is able to generate relevant information in different contexts and on different perspectives, taking care of regulatory and regulatory, statistical and IT, commercial and budget aspects, as a starting point for an activity oriented to the needs of each stakeholder, throughout the entire life cycle of the product.
- Data management, storage and analysis solutions (software, data,platform, eCRF, source interconnection)
- Identification of areas of applicability of RWDs/RWEs
- Implementation of RWE research project: from drawing to final output
- Value of evidence based in healthcare
- Public Health (Clinical associations and Institutional)