FHA’s proactive data quality and medical review initiatives can ensure the accuracy, quality and integrity of the safety and efficacy data captured in the clinical trial. This may result in:
- Accelerating regulatory review times
- Minimizing regulatory burden and queries
- Improving communication among sponsors, investigators and regulatory agencies
- Providing an accurate representation of the safety profile of a drug and its benefit-risk assessment
- Improving patient safety
Clinical trial programs may have missing source documents, inaccurate company causality assessment, mischaracterization of clinical/safety events, sub-optimal patient narratives, sub-optimal medical review of SAEs, and poorly coded data and/or data entry conventions.
FHA’s highly experienced team of medical professionals will review, validate and remediate your clinical and safety data to ensure the highest quality and medical standards are met.
1: ESTABLISH DATA QUALITY GOALS – Establish data quality goals to ensure the accuracy, quality, and integrity of the safety and efficacy data captured in the clinical trial(s).
2: DESIGN AND PLAN BLUEPRINT – Design a tailored approach which includes; developing process maps, guidance documents, quality standards, training resourcing, and documentation strategy.
3: PLAN IMPLEMENTATION – Identify, review, validate and remediate data within the database(s) to ensure the highest quality standards are achieved.