Post-Authorization Safety

Post-Authorization Safety and Efficacy Studies (PASS/PAES)

Investigating the frequency of a medicine’s known adverse events, potential risks, and benefits in a population of real-life users. Robust designs and strategic implementation are key to fulfilling post-authorization commitments.
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Post Authorization Safety and Efficacy Studies Pass PAES

We help you with all steps of designing and executing a post-authorization safety study (PASS) or post-authorization efficacy study (PAES). 

Our solutions enable you to adhere to risk management requirements, post-marketing commitments, and establish evidence for safety and effectiveness, in a real-world setting.

What do you get with Post-Authorization Safety and Efficacy Studies (PASS/PAES)?

Specialized, strategic consulting

We support the development of pharmacoepidemiology plans for regulatory approval through post-marketing surveillance.

Pioneering experience

We have an established track record in global active safety surveillance and pharmacoepidemiology programs under the ENCePP seal.

Regulatory acceptance

Our study protocols, including EURAS/INAS, are approved and recommended by international regulatory agencies.

Studies specific to your needs

Mandatory or voluntary Post-Authorization Safety and Efficacy Studies (PASS/PAES) based on product risk management plan commitment and strategy.

Client Results

30+ years CRO

Our global multidisciplinary team consists of specialists in non-interventional research as well as a worldwide network of healthcare personnel. We have conducted more than 500 non-interventional studies covering over 2 million patients.

Clinical operations

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.

Depth

Benefit from our deep expertise in epidemiology, pharmacovigilance, and regulatory requirements to meet your safety requirements.

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.