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)

Study/Protocol

Assesses risk at study design and set-up, prior to protocol approval and site initiation. Monitors for ongoing risks during study execution as well.

Science Review

Assesses risk on a scientific and medical level with focus on study data quality and completeness, including efficacy and safety results.

Trial Sites

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.

Data Management

Assesses good clinical practice data quality on a study level.

Service Providers/CROs

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.

Capabilities Scope