Consulting Services
Strategy Development / Leadership / Coaching
- Clinical Development Plans
- high level study designs
- high level timeline and budget estimations
- department performance assessment
- systems review
- coaching/mentoring team members
- Leadership oversight of teams
- study rescue
- asset transfers
- fractional leadership services
Project Management
- timeline/budget development and management
- risk identification and mitigation strategies
- team oversight
- newsletter development
- study management plans, project plans
- oversight of monitoring activities including report review and trend analysis
Finance / Budget / Timeline Development & Management
- budget development for studies, programs, vendors
- budget management and control
- financial forecasting and accruals
- invoice review and approvals against contracts and work deliverables
- invoice tracking
- timeline development for studies, programs, vendors
- timeline management and control
Monitoring
- monitoring visits (on site and remote)
- site communication and follow-up
- site training
GCP Compliance / QC
- compliance check of monitoring, eTMF
- inspection readiness
- quality control of tables, listings, figures (TLFs) and documents for submission
SOP Development / Quality Management Systems
- SOP and Quality Management System development
- assessment of clinical SOPs / QMS for compliance and efficiency
- streamlining of clinical SOPs, work instructions, templates
Vendor Selection & Management
- identifying potential vendors
- developing Request For Proposal (RFP) document to guide vendor selection process
- evaluate vendor quotes
- select and contract vendors
- establish expectations with vendors
- manage timelines/budgets/deliverables
Medical Writing
- Clinical Study Report (CSR) drafting, review, modification
- Health Authority document drafting for clinical sections (INDs, IND section documents, BLA documents/coversheets, TLF and data package compilation
- pre-publishing activities
- developing protocol synopses and draft protocols
Team Development
- performance reviews and assessments
- establishing Key Performance Indicators (KPIs)
- setting expectations with team members
- 1:1 meetings for performance