Capabilities - Scope
Quality Risk Management Associates provides expert consulting support in the following areas. Risks in each area are assessed proactively and on a continuous basis.
RISK ENTITIES (PROACTIVE RISK ASSESSMENTS)
Assesses risk at study design and set-up, prior to protocol approval and site initiation. Monitors for ongoing risks during study execution as well.
Assesses risk on a scientific and medical level with focus on study data quality and completeness, including efficacy and safety results.
Assesses key risk indicators and critical quality metrics, including data at investigational sites.
Affiliate/Centers of Excellence
Assesses study management risks at the operational levels within a global organization.
Assesses good clinical practice data quality on a study level.
Assesses risk at service providers and CROs in support of all operational areas, including systems and processes involved in study development, study management and safety reporting.
Pharmacovigilance (Drug Safety) including Safety Operating Centers
Assesses pharmacovigilance (including post marketing surveillance) and clinical trial safety reporting through established key risk indicators required by regulation.