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

We help design and execute post-authorization safety studies (PASS) and post-authorization efficacy studies (PAES). Our solutions enable your organization to meet risk management requirements, fulfill post-marketing commitments, and establish evidence for safety and effectiveness in a real-world setting.

Post-authorization safety and efficacy studies

Conduct your post-authorization safety and efficacy studies with us.

Utilize our specialized and strategic consulting

We support the development of pharmacoepidemiology plans for regulatory approval through to post-marketing surveillance. We assist both mandatory and voluntary post-authorization safety and efficacy studies. Our services seamlessly reflect your organization’s product risk management plan and strategy.

Meet your safety requirements with us

We have an established track record in global active safety surveillance and pharmacoepidemiology programs under the ENCePP seal. We carefully utilize study protocols, including EURAS/INAS, that are approved and recommended by international regulatory agencies.

Decades of experience as a contract research organization

We have conducted more than 500 non-interventional studies covering more than 2 million patients. Our global team includes specialists in non-interventional research, plus an international network of healthcare personnel. Benefit from our deep expertise in epidemiology, pharmacovigilance, and regulatory requirements to meet your safety needs.

Full-service clinical operations team with stringent quality control

Your research will be supported by a full-service, global clinical operations team that is highly experienced in study design. We take a wide range of factors into account, including study objectives, protocol development, country-specific regulatory requirements, data analytics, and reporting.

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. These methods fulfill European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulatory requirements.

Conoce Oracle Life Sciences


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