When it comes to data quality and integrity, FHA makes all the difference.
Without question, drug development is becoming more sophisticated and complex as there is an escalation in the volume and type of data collected in clinical trials. The Data residing in multiple databases and being handled by multiple sources (clinical trial sites, CRO’s, sponsors) also creates data quality challenges.
Trust FHA to help you achieve your objectives in an ever more challenging world of data collection, analysis and reporting. Our accomplished team brings a wealth of experience and Peace-Of-Mind Partnership to accomplishing your goals, however problematic.
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.