Office of Business Informatics (OBI)
Provides leadership and coordination of informatics activities across CDER and makes recommendations that support long-term strategic goals;
Builds strategic partnerships with internal clients and conducts joint business planning with CDER offices to systemically assess and prioritize business informatics needs; and
Translates business priorities into informatics initiatives that are delivered through strategic partnerships, such as with the FDA Office of Information Management (OIM), and provides overall program management for those initiatives.
Descriptions of Organizational Units
Immediate Office
- Assesses Client requests and makes recommendations on timing, scope, funding, and required resources. Recommends projects to be added to the Informatics Action Plan and assigns resources as necessary to work on projects. Manages funding, acquisitions, and resource planning to ensure the successful delivery of approved projects.
Division of Drug Quality and Compliance Services & Solutions
- Build strategic relationships with the Office of Compliance (OC), Office of New Drugs (OND), Office of Management (OM), and the Office of Pharmaceutical Quality (OPQ) and conduct joint business planning to systemically assess and prioritize business informatics needs.
- Establish and implement a portfolio of services and solutions in support of critical drug quality and compliance business needs.
Products
- Inspection Management Solutions
- Pharmaceutical Quality and Compliance Solutions
Division of Regulatory Review and Drug Safety Services & Solutions
- Build strategic relationships with the Office of New Drugs (OND), Office of Generic Drugs (OGD), Office of Surveillance and Epidemiology (OSE), Office of Translational Sciences (OTS) and Office of Medical Policy (OMP) and conduct joint business planning to systemically assess and prioritize business informatics needs.
- Establish and implement a portfolio of services and solutions in support of critical regulatory review and drug safety business needs.
Products
- Regulatory Review Solutions
- Drug Safety Analytics
Division of Business Management Services & Solutions
- Lead the modernization and operations of work management and business intelligence capabilities in support of the CDER Informatics Platform
- Foster improved user adoption and understanding through the implementation of communication, learning, and training strategies for the Platform
Products
- Integrated Work Management Capability (Panorama)
- Marketplace for Scientific analysis and regulatory decision-making (Mercado)
Division of Data Management Services & Solutions
- Interact with applicants, sponsors and the Center for Drug Evaluation and Research (CDER) personnel to provide accurate and timely guidance on electronic submission issues; support development of guidance and regulations associated with data management issues.
- Provide and modernize solutions and capabilities to receive electronic and traditional submissions; validate incoming submissions to ensure the compliance of FDA published data standards.
- Develop the strategies, priorities, initiatives and measures to oversee and improve the inbound submission process; provide data management services across CDER.
- Provide consultation services and solutions on CDER Records Management standards and policies in compliance with Federal laws and regulations.
- Develop and conduct training programs for internal and external stakeholders targeting standardized electronic submissions.
Products
- Electronic Submissions and Data Support
- Document Room Operations
- Master Data Management Services
- Records Management Coordination
- Review Tools Training
Integrated Data Management Capability Team (IDMCT)
- Lead the modernization and operations of data management capabilities in support of the CDER Informatics Platform
Products
- Integrated Data Management Capability (Integrity)
Contact Us
Office of Business Informatics
10903 New Hampshire Avenue
White Oak Building 22, Suite 1100
Silver Spring, MD 20993
Phone: 301-796-1000
Email: [email protected]