Strategic Planning

• Clinical Development Plan
• Protocol Design
• Timelines

Safety Services

• Safety reporting assistance (SAE and UADE)
• Monthly/quarterly safety report preparation
• Committee establishment and oversight (e.g., Data Safety Monitoring Board)

Research Compliance & Regulatory Services

• Auditing (e.g., vendors, GCPs/sites, trial master files)
• Regulatory submissions, report writing contributions

Clinical Services

• Document preparation (e.g. informed consent forms, study templates/logs, study plans)
• Case report form design and development
• CRO and vendor evaluation, selection, management and closeout
• Committee establishment and oversight (e.g., Steering Committee, Clinical Events Committee
• Site Selection and/or oversight including budget/investigator agreement negotiations
• Training (e.g., in-house staff, site study staff, investigator meeting)
• Project Management
• Medical Monitoring (review SAE and pregnancy reports, Med Hx/ConMed/AE coding reviews, answer protocol questions as required)
• Monitoring/site management and/or report review
• Data analysis, interpretation, and presentation
• Final study report preparation

Additional Services

• Staff recruitment
• SOP development and/or revisions
• External training
• Personnel management (in-house and field associates)

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