Evidence generation has an increasingly important role in decisional steps within the healthcare field. Knowing the complexity of this field is an important tool to benefit from the nowadays availability of clinical data. In our Evidence Generation courses, designed for professionals dealing with clinical trials, statistical analysis, and manuscripts among others, the concepts behind these two fields are addressed: the rationale behind the use of these data, including real-world data and real-world evidence, statistical analysis and publication.
Evidence Generation: What It Means in the Life Science Sector
LS Academy offers evidence generation courses designed for professionals working in clinical research, medical affairs and regulatory affairs. The term refers to the process of collecting and analysing real-world data and evidence to support clinical, regulatory and market access decisions. Real World Evidence (RWE) and Real World Data (RWD) are now an integral part of the daily work of professionals involved in clinical studies, medical writing or statistical analysis in the pharmaceutical and medical device sectors.
Real World Evidence and Real World Data: Why They Matter
Data collected outside randomised clinical trials, such as electronic health records, registries and questionnaires completed directly by patients, provide a broader picture of how effective a treatment is in everyday clinical practice. Real-world evidence in healthcare helps pharmaceutical companies, CROs and academic institutions make decisions based on concrete data, rather than relying solely on results obtained under controlled conditions.
Real World Data Training: Who It Is For
LS Academy’s courses are designed for professionals involved in clinical studies, statistical analysis, medical affairs and scientific manuscript writing. Each course in the training programme focuses on a different aspect of evidence generation, from designing an observational study and writing the study protocol to managing Patient-Reported Outcomes (PROs) when collecting RWE.
Evidence Generation in Life Science: Training Built on Real-World Experience
Since 2010, LS Academy has worked alongside pharmaceutical companies, medical device manufacturers, CROs and medical associations to design tailored training programmes for the Life Science sector. Its evidence generation courses draw on this hands-on experience and are continuously updated to reflect regulatory and methodological developments in the industry.
Frequently Asked Questions
What is evidence generation in the Life Science sector?
It is the process of collecting and analysing clinical and non-clinical data, often derived from real-world practice, to generate evidence that can support clinical, regulatory or scientific communication decisions. It includes study methodologies, data collection and statistical analysis.
What is the difference between Real World Data and Real World Evidence?
Real World Data (RWD) are raw data collected outside randomised clinical trials, for example from electronic health records or registries. Real World Evidence (RWE) is the clinical evidence obtained by analysing these data using a defined methodology.
Who are LS Academy’s evidence generation courses designed for?
They are designed for professionals working in clinical research, medical affairs, biostatistics and medical writing in the pharmaceutical and medical device sectors, whether they work for companies, CROs or academic institutions.
What skills can you gain from Real World Evidence courses?
Participants learn how to design observational studies, collect real-world data using appropriate methodologies, manage Patient-Reported Outcomes (PROs), and write protocols and manuscripts in line with industry standards.