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
AND BIOSTATISTICS

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

ICTA a two-fold medical and statistical 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:

Incidence/prevalence

Burden of disease

Quality of life

Effectiveness/safety

Treatment patterns

Costs

Cost-effectiveness

OUR SECURE DIGITAL SOLUTIONS FOR AN INTEGRATED MANAGEMENT

PROJECT
MANAGEMENT

i-TMS

eREPORT

SECURE
COMMUNICATION

i-COM

RANDOMISATION

IWRS / RTSM

DECENTRALISED
SOLUTIONS

Patient enrollment

Patient information

Electronic consent

Teleconsultation

Telemonitoring

DATA
COLLECTION

e-CRF

e-PRO

e-diary

e-COA

Connected tools

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)