Observational Study Design and Execution

PrimeVigilance’s Human Data Research team supports clients in the design and implementation of prospective observational research approaches, including cohort studies, patient registries, and surveys of patients or health care practitioners.

PrimeVigilance’s Human Data Research team supports clients in the design and implementation of prospective observational research approaches, including cohort studies, patient registries, and surveys of patients or health care practitioners.

This includes all steps of an observational study, from protocol development and writing of plans or reports, to coordinating or leading the study. Studies may include:

• Early access programs and confirmatory studies for drug approved under Breakthrough Therapy Designation
• Post marketing and observational pharmaco-epidemiological studies
• Post authorisation studies to assess efficacy (PAES) and/or safety (PASS)
• Evaluation of burden/effectiveness/utility of risk minimization efforts
• Observational studies for new supplemental indications and label revisions, rare/orphan disease, etc.

PrimeVigilance’sHuman Data Research team partners with relevant internal and external stakeholders to support regulatory approval and market adoption through observational research. PrimeVigilance uses a multidisciplinary approach such as regulatory, clinical and methodological expertise and scientific rigour, with the business acumen, consulting insights, and problem-solving capabilities of our organisation.

PrimeVigilance helps you generate evidence for a variety of different stakeholders, including:

• Supportive data regulators need to review for approval, licensing and label revisions
• Evidence physicians need to prescribe a drug with confidence
• Information patients need to choose and adhere to a drug

The clinical research experience of ERGOMED also allows us to offer support in managing study operations, and PrimeVigilance’s regulatory affairs colleagues can provide regulatory support, such as responses to regulatory authority questions if studies are conditions of marketing authorisation.