Expertise

Clinical

• Biostatistics/Programming Support

• Clinical Operations Support

• Clinical Program/Project Management

• Clinical systems design and review (eTMF, CDMS)

• Data Management

• Due Diligence

• Process Review and SOP Development

• Strategy

 

Regulatory

• Advertising and Promotion Reviews

• eCTD Publishing and Life Cycle Management

• Labeling

• Preparation, Support and Assistance with Regulatory Agency Interactions•

• Regulatory CMC

• Regulatory Communications

• Regulatory Operations

• Regulatory Program/Project Management

• Regulatory Strategy

• Submission and Medical Writing Drug Safety/Pharmacovigilance

• Benefit/Risk Management

• Clinical Trial Processes

• Post-marketing Outreach Program Safety Management

• PV Auditing

• Regulatory Safety Reporting

• Safety Issue/ External Inquiry Management

• Safety Surveillance & Signal Detection

• Serious/Targeted AE Review

• Signal Detection and Management Processes

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Drug Safety/Pharmacovigilance

• Benefit/Risk Management

• Clinical Trial Processes

• Post-marketing Outreach Program Safety Management

• PV Auditing

• Regulatory Safety Reporting

• Safety Issue/ External Inquiry Management

• Safety Surveillance & Signal Detection

• Serious/Targeted AE Review

• Signal Detection and Management Processes

 

Quality

• Audits (Investigator Site Audits, Process, Corporate, Regulatory)

• Due Diligence

• Inspection Readiness Support

• Mock Regulatory Inspections

• Quality SOP Preparation and Training

• Quality System Assessments

• Regulatory Inspection Remediation

• Trial Master File Assessments

 

Medical Affairs

• Legacy Product Support

• Medical / Scientific Reviews

• Medical Communications (Peer-Reviewed Publications, Advisory Boards, Advocacy Group Liaisons)

• Medical Education

• Medical Project Management

• Medical Strategy

• Phase 3b / Phase 4 studies

• Post-Market Study Planning, Design, and Execution