Clinical Project/Program Management & Related Services

• Manage global clinical trials
• Project Management rescue services
• Identify, manage & provide oversight of CROs & vendors
  (including international)
• Manage RFP process
   - Develop thorough task matrix of CRO & vendor responsibilities
• Review & negotiate budgets & contracts (CRO, vendor & site)
• Develop & manage Sponsor budgets & timelines
• Site ID, qualification, monitoring & management
• Develop & finalize clinical protocols, ICFs & study-related documents
  (e.g., Monitoring & Patient Recruitment Plans)
• Develop patient recruitment strategies
• Manage & train monitors & study staff
• Review specifications for IVRS, e-diaries
• Clinical supplies planning & management
• Investigator & CRO (kick-off) meeting planning & management

• Manage EDC & DM Operations
• Formulate timelines for the completion of all DM activities
• CRF/eCRF development
• Provide input & recommendations on clinical systems & DM tools
• Conduct on-site audits of Data Management activities, processes,
hardware & software*

*Indicates services that are sub-contracted & managed by RCSWP

• Medical Writing (protocols, CSRs, safety narratives)
• Benefits/risk analysis, risk management & input into drug safety &
Pharmacovigilance systems*
• SOP development including process mapping
• GCP compliance audits*
• Pre-approval inspection (PAI) preparation
• Coordination of due diligence activities
• Coordination Of Expert/KOL & Advisory Board Meetings

*Indicates services that are sub-contracted & managed by RCSWP

• Orchestrate meetings with FDA (pre-IND, EOP2, pre-NDA, Guidance meetings)
• Regulatory document preparation (INDs, NDAs, CTA, MMAs, CTDs, Briefing
documents, Special Protocol Assessments, Labeling, Pediatric Requests,
regulatory SOPs, etc.)

Members of the team have extensive
experience in several therapeutic areas:
• CNS – Alzheimer’s, bipolar disorder, depression
(pediatric, adult, geriatric), anxiety
• Cardiovascular – hypertension, PAD/IC
• GI - C-IBS, POBD/Post-op Ileus, chronic constipation, Ulcerative Colitis
• Infectious diseases – grade IV neutropenia/AIDS, multi-lobar pneumonia, CSSI
• Oncology – breast, lung, and renal cell carcinoma, melanoma, sarcoma
• Pain management - Chronic pain, primary dysmenorrhea, fibromyalgia
• Respiratory – asthma
• OB/GYN/Women’s Health
• Other – smoking cessation