Choose the best clinical strategy with the help of our seasoned clinical drug development experts.…
Real World Evidence
With a large experience in health data assessments, ICTA teams are able to define the best processes for generating, processing, and analyzing real-life data, regardless of their source (primary collection / secondary use) and final use (market access strategy, regulatory purposes, medical communication…).
THE SYNERGY OF MEDICAL AFFAIRS
Real World Evidence is important to commercial and regulatory outcomes as well as long-term product life cycle management
ICTA has extensive experience in the design and execution of real-world primary and secondary data collections to evaluate clinical, economic, epidemiological and patient-reported outcomes.
Based on a sound understanding of the strengths and limitations of a variety of data sources and study designs, our teams advise you on what would be the best methodology to achieve your study goals. We have the capacity and tools to design and undertake projects like secondary data use studies (chart reviews, existing database analysis) and primary data collection studies, ranging from simple cross-sectional local surveys to large prospective multi-country non-interventional clinical studies.
MEDICAL AND BIOSTATISTICAL EXPERTISE
A dual medical and biostatistical expertise to guide you towards the right choice of study design according to the scientific objective and the ethical/regulatory and logistic constraints.
- Non Interventional studies
- Patient-centered studies
- Patient registries
- Pragmatic trials
- Secondary use of existing data
- Electronic health record studies
- Administrative and claims database studies
- SNDS analysis
- Mixed studies (primary data collection + secondary data use)
INNOVATIVE METHODOLOGICAL APPROACHES
Innovative methodological approaches to counteract the pitfalls related to the design of Non-Interventional Studies (NIS).
- Optimised design to make your project as short and as inexpensive as possible
- Design and implementation of sophisticated data collection and management tools to study simultaneously multiple outcomes and subgroups of interest
- Study design and management to allow for the generalizability of the study outcomes to the entire targeted population
EXAMPLES OF EVIDENCE/DATA WE CAN GENERATE:
Burden of disease
Quality of life
OUR SECURE DIGITAL SOLUTIONS FOR AN INTEGRATED MANAGEMENT
IWRS / RTSM
OUR KEY SUCCESS FACTORS
- Expertise in designing RWE studies throughout the product life cycle to support the product value of pharmaceutical, biotech and medtech companies
- Dedicated operations and scientific teams trained to traditional and innovative real world study designs
- Qualified and dedicated teams with an agile culture that enables rapid adaptability as study requirements shift
- Cross-departmental structure designed to ensure the highest quality of deliverables
- Robust study oversight procedures and quality management standards fully integrated into our operational processes
- Acknowledged technology-driven solutions developed in accordance with the regulatory requirements of 21 CFR Part 11
- Solid 39-year experience across a broad range of therapeutic areas
- Qualified team of medical writers to support scientific communications (abstracts, posters, articles)