Office of Regulated Activities

The Business Support Office coordinates all requests for regulatory support, Sponsor protocol reviews, and maintains 21 CFR 11 compliant data systems to support FDA-Regulated activities.

• Ensures workload requirements are met for establishing service support
• Coordinates internal reviews for initial requests
• Ensure regulated clinical systems are implemented and maintained in compliance with 21 CFR part 11 regulations
• Assist with requirements definition
• Author and review validation plans, tests, and reports
• Provide expert validation strategy and advice
• Knowledge management, collaboration, and document control advice and support

Regulatory Affairs (RA) professionals provide expert regulatory strategy for the development of clinical drugs, biologics, and vaccines in support of TSGl-DA medical mission. Support includes providing regulatory strategy and guidance to IPTs, acting as the FDA liaison, analyzing regulatory intelligence and preparation of regulatory submission documents for submission to the FDA. Regulatory support is provided on the full continuum of a product's developmental lifecycle.

• Provide expert strategic regulatory advice
• Conduct and analyze regulatory intelligence
• Guide development of drugs, vaccines, blood & biologics
• Serve on Integrated Product Teams
• FDA liaison
• Prepare and review regulatory submission documents

Regulatory Affairs professionals provide expert strategic regulatory expertise for development of medical devices and diagnostics in support of USAMMDA, as well as external commands. Support includes providing expertise and regulatory direction to IPTs and Working Groups, serving as the FDA liaison, development of regulatory strategies and plans, providing regulatory guidance, and review of regulatory submission documents prior to submission to FDA. Regulatory support is provided on the full continuum of a product's developmental lifecycle as appropriate.

• Expert strategic regulatory advice
• Medical devices, diagnostics, kits, wearables
• Serve on IPTs
• FDA Liaison
• Review regulatory submission documents

Data managers are responsible for the quality and integrity of clinical research data collected in support of TSG-DA sponsored protocols/projects. Support ranges from full support to oversight and consultation, participation on IPTs, development of study-specific protocols and associated databases for study data entry, data management plans and related documents.

• Expert clinical data management support
• Serve on IPTs/Project teams
• Review study protocols and provide feedback
• Develop and maintain Clinical Data Acquisition Standards Harmonization conforming Case Report Forms
• Develop, test, and validate study-specific databases
• Develop and maintain essential data management documents including, data management plans, related documents
• Train and maintain records on users of clinical databases
• Manage study data collection and cleaning, maintain data integrity
• Perform study data extracts and manage data transfers (internal and external)
• Perform data management deliverables archive

Biostatisticians ensure the integrity, appropriateness and regulatory-compliance of study designs and statistical analyses used in TSG-DA-Sponsored, U.S. FDA-regulated non-clinical and clinical studies of investigational drugs, biologics, and medical devices. The Biostatistics Branch provides regulatory oversight of contract research organizations responsible for the provision of full statistical support of OTSG-Sponsored, U.S. FDA-regulated non-clinical and clinical studies of investigational products.

• Ensures integrity, appropriateness, and regulatory compliance of stud designs and statistical analyses
• Provides oversight and consultation of contract research organizations responsible for statistical support of TSG-DA sponsored products
• Supports clinical and non-clinical studies of investigational products

Clinical trial managers provide overall management of clinical research by providing consultative clinical support to IPTs, coordination of activities among the branches of ORA, vendors, and the product manager to facilitate review and submission of protocol documents, coordinate study site implementation and close-out activities.

Clinical trial monitors provide monitoring support for TSG-DA sponsored clinical trials, IPT consultation, authoring of clinical monitoring plans and reports, perform monitoring visits to clinical sites, and ensures the trial master file is complete for the study.

• Clinical Trail Management
  • Overall clinical trial management
  • Coordination of activities between regulatory, clinical, ORA branches, vendors, and product management
  • IPT consultation
  • Coordination of Sponsor Protocol Review Board submission
  • Coordination of study site implementation activities
  • Coordination of study close-out activities
• Clinical Trial Monitoring
  • Author clinical monitoring plans and reports
  • IPT consultation
  • Participation in protocol and other study document development and review
  • Perform clinical site monitoring visits for TSG-DA sponsored clinical trials
  • Identify and resolve issues during clinical trial execution
  • Ensures trial master file is complete

Safety specialists and pharmacovigilance physician provide safety pharmacovigilance and oversight for all TSG-DA sponsored clinical trials involving human subjects, and to ensure compliance with U.S. FDA safety monitoring and reporting requirements. Support includes Sponsor determination of Serious Adverse Event (SAE) attribution and requirements for mandatory expedited safety reporting to the FDA, medical terminology coding (Medical Dictionary for Regulatory Activities, MedDRA), consultation on IPTs, review of clinical study protocol documents, advice on data and safety monitoring board requirements, and product safety surveillance. A safety physician is available at all times, on call to provide medical management of SAEs and oversight of clinical trials to ensure compliance.

• Clinical trial adverse event management
• Serious adverse event determination and reporting
• Clinical protocol document review (protocol, informed consent document, investigator's brochure)
• IPT and Data Safety Monitoring Board consultation
• Adverse event coding
• SAE reconciliation with the clinical database
• Pharmacovigilance (product safety surveillance)

Product compliance scientists provide manufacturing, nonclinical FDA regulated support services and compliance for TSG-DA Sponsored investigational medical products (drugs, biologics, devices). Support includes facility qualification visits, review of batch records, release testing, stability protocols and reports, providing out of specification notifications, Good Manufacturing Practice manufacturing deviation notifications, qualification of repositories, investigational product shipping qualification and validation review, and product accountability authorizations.

• Ensure compliance with FDA regulations manufacturing and stability for investigational drugs, biologic, and medical device products
• GMP/Good Laboratory Practice/Quality System Regulation Manufacturing Facility Qualification (site visit)
• Perform facility and repository qualification visits
• Review batch production records, release testing, stability plans and reports
• Provide GMP manufacturing deviation notifications
• Provide investigational product shipping qualification and validation review
• Maintain product accountability and provide shipment authorizations
• Provide out of specification notifications and advise on product integrity

The RO Branch provides world-class regulatory submissions, document control and medical writing support, which includes preparation, submission, storage and tracking of all FDA regulated documents. All FDA Sponsor documents, including FDA submission and clinical trial master files, are maintained by the RO Branch in a 21 CFR 11 FDA-compliant electronic document management system. High-level capabilities include the following:

• Medical writing for all FDA application types
• Publishing and transmittal of Preparation and tracking of regulatory submissions
• Document Storage and control archiving of all regulated documents and trial file content in 21 CFR 11 compliant document management system according to FDA and Army regulation