Non-Interventional Studies

Non-Interventional Studies(NIS)

Assess short and long-term treatment patterns to understand the effectiveness, safety, use, and value of your product.
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Non-Interventional Studies Research

Observational research enables long-term evaluation and generates evidence to define, substantiate, and communicate the value of your treatment to different stakeholders.

We’re proud to offer decades of experience in observational and non-interventional research studies. This allows us to be fully adaptive when realizing your product’s value.

Our treatment value experts understand the varied needs of patients, payers and healthcare professionals, as well as regulatory requirements. We’ll help you demonstrate your treatment's value for these audiences by identifying the actions needed to maximize your treatment's potential before launch and after approval, and minimize the possible risks.

What do you get with Non-Interventional Studies(NIS)?

Health Economics and Outcomes Research (HEOR)

Get comprehensive research and data to evaluate patient outcomes, treatment patterns, resource utilization, and costs.

Epidemiology

Accurate and holistic analysis on the incidence, distribution, natural history, and control of the disease and factors relating to health.

Robust scientific and epidemiologic background

We offer solid, retrospective, cross-sectional, prospective, and mixed designs using primary data collection, as well as secondary data research using existing databases, claims, and registries. These studies fulfill local expectations and legal requirements. 

Large prospective cohort studies

We work closely with advocacy groups, scientific communities, and patient associations to include patients diagnosed with a specific disease, most frequently rare diseases and targeted oncology indications.

Registry studies

Leverage existing registry data as a pooled data source. 

Client Results

30+ years

Of experience as a contract research organization (CRO). Our team consists of specialists in non-interventional research as well as a global network of healthcare personnel. We have conducted more than 500 non-interventional studies covering over 2 million patients.

1500+ studies

We’ve published over 1500 studies covering over 200 conditions, with a special focus on oncology and rare diseases.

Depth

Research is supported by a full-service, global clinical operations team that is highly experienced in study design, taking into consideration study objectives, protocol development, country-specific regulatory requirements, data analytics, and reporting.

Standards

We are ISO 20252 and 27001 certified and meet GCP, GEP, GPP, and ENCePP requirements. Our proprietary electronic data capture (EDC) applications assure high-quality data collection, data cleaning, and data validation that fulfill European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulatory requirements.

Networks

Clients benefit from our extensive partnerships and relationships with global networks, academia and scientific committees, advocacy groups, and patient associations.