Details Matter
The big picture is essential to the drug development process but managing the details can make or break your database lock.
Cleaner data, faster results
We are a niche provider of independent patient profile review services. We work with your multidisciplinary team to provide a detailed review of a patient’s entire experience on your study.
What is a patient profile?
A Patient Profile is a listing or programmed output of a subject’s cumulative experience at a defined point in the study’s life cycle.
What is a patient profile review?
A Patient Profile Review is a comprehensive, matrix-based review of study subjects as an adjunct to traditional or risk-based monitoring, or as standalone review when time is of the essence.
Independent review of data collected over the study’s life cycle
Hybrid review of data to date
Involves different functional groups such as Data Management, Clinical Operations, Biostatistics, and Imaging
Provides feedback on the quality and consistency of the monitoring being performed
When are patient profiles reviewed?
Patient Profile Review can be performed to support:
• Project specific milestones
• Data Safety Monitoring Board meetings
• Ongoing assessments of patient disposition
• Final analysis
Who We Are
Bench-top to product approval. We understand the process. The founders of Clinical Matrix Review have worked in drug development for over 25 years. This experience ranges from basic pharmacology, pharmacokinetics, Phase 1-4 clinical protocols oversight, data cleaning, statistical analysis, clinical study report writing, NDA development, FDA advisory board review and public health.
Our focus has been the management and oversight of the clinical studies that support health authority submission. We understand how study management and data integrity support the successful analysis of your data. We have worked with companies of all sizes from the large pharmaceutical organization to the startup biotech. We understand the development and financial challenges faced by each. We understand the critical milestones that drive your decisions.
We believe the roles of Clinical Research Associate and Data Manager are rapidly shifting. Efficiency in moving from data entry and monitoring to data cleaning and database lock now requires a comprehensive understanding of database platforms, functionality and process.
Clinical Matrix Review staff have been involved in patient profile review with a focus in oncology and antivirals, however, trends in the industry indicate patient profile review is more commonly being used as a data cleaning tool across therapeutic areas.
What We Do
Clinical Matrix Review works with your multi functional team to develop an overall strategy for the review of your essential datasets using a patient profile format. This matrix review strategy allows each functional area to assess the data most relevant to their contribution to the study life cycle.
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Clinical Matrix Review
