Specialized Products | Data Monitoring Committees
Cardiac Safety | Project Turnaround | CRO Services
Longitudinal Data Integration
Longitudinal Data Integration:
Integrated Summaries of Safety and Efficacy, Data Warehousing and Registries.
Whether you need to support clinical product decision making, regulatory authority interaction, or just hypothesis generation to drive efficiencies in the product development, ACI’s experts can help. Our unique blend of regulatory, technical and clinical experts are experienced with the process of combining disparate clinical study databases and operational Meta-data into a standards-driven integrated database that is the framework for decision making.
ACI views creation of a high quality NDA, ISS, and ISE as an amalgam of all the small choices and decisions made during the data integration process-- much more than a simple mapping of variables from multiple studies to a singular standardized database structure such as CDISC SDTM. Merely mapping variables, although technically correct, can result in inaccurate or misleading results because of clinically illogical integration. At ACI, our senior staff works with sponsors to make sure the proper meta-data decisions are made, so that the meaning of the clinical information will remain consistent over studies. Understanding the clinical development context over time may impact a data integration decision because the ACI’s unique blend of experienced clinical and statistical expertise enable sponsors to construct the proper integration strategy from which to construct their integrated summaries of safety and efficacy submissions.
Since it’s inception in 2001, ACI has been providing clinical data integration services in support of integrated summaries of safety and efficacy (ISS, ISE) for regulatory filings, for CDISC compliance, for data warehousing initiatives, and for patient and product registries. ACI has a wealth of experience in the integration of multiple study databases. Senior ACI personnel have been involved with many NDA submissions, large international patient registries, and data warehousing initiatives.
Why is ACI your best choice for these activities?
- Extensive experience performing data management, data integration, CDISC data conversion, and analysis of clinical trial data in support of regulatory submissions and clinical decision making. ACI has designed safety data warehouses to combine pharmacovigilance and clinical trial databases specifically for the purpose of safety signal detection.
- ACI is a CDISC Registered Solutions Provider. CDISC standards drive cost efficiencies
- Special expertise and focus on safety analysis and signal detection. ACI has led numerous Data Safety Monitoring Committees.
- Data warehousing design and data analysis tool set emphasis is focused on the data consumer: Research Clinicians, Regulatory Authorities and Biostatisticians.
- Committed to applying technology to improve the drug development process.
Solutions:
- Regulatory Submissions
- Integrated Summary of Safety (ISS)
- Integrated Summary of Efficacy (ISE)
- Large Simple Safety Studies
- Non-regulatory Offerings
- Clinical Data Warehousing
- Product Registries
- Patient Registries
- Due diligence on in-licensing compound
