Active Surveillance Studies

Active Surveillance Studies

Evaluate the probability and frequency of adverse events as part of post-marketing risk assessment for medical products.
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Regulatory agencies seek to reduce the impact of adverse events in financial and humanistic terms.

We conduct post-authorization safety studies (PASS) to investigate the frequency of already known adverse events and possible rare adverse events in a patient population that is typical of real-life users. We use the EURAS/INAS study design, which has been internationally recognized as being scientifically and methodically robust.

What do you get with Active Surveillance Studies?

Robust methodology in risk/benefit assessment

We question participants directly at baseline and follow-ups, to spot co-variables you won't find anywhere else.

Regulatory acceptance

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

Pioneering experience

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

Client Results

60

Global epidemiology studies

15 million

Patient subjects worldwide

300+

Published pieces in peer-reviewed journals

Direct-to-patient

Patient-centric, direct-to-patient approach and long-term follow up independent of the site-based study setting.

Claims data

Our expansive access to existing claims data allows us to design hybrid studies that link secondary to primary data, particularly for rare disease and targeted oncology indications.

Validation

Key outcomes are validated with medical documentation from treating physicians.