Consulting Services
Program Management
Support biotech clients with full service drug development program management:
- Drug substance and drug product manufacturing oversight
- Management of preclinical and toxicology studies
- Overseeing of regulatory activities
- Clinical trial management
- Associated business activities
- Intellectual property strategy
- Partnership development
- Due diligence
- Contract negotiation
Vendor Management
Support biotech and pharma clients with CRO selection and oversight:
- Prepare Requests for Proposals (RFPs)
- Solicit, receive, and review CRO proposals
- Prepare proposal comparison and make recommendations
- CRO contract preparation and negotiation
- Participate in project kick-off
- Oversee CRO activities from startup through close-out
- Participate in team calls
- Provide ongoing risk assessment and mitigation plans
- Manage scope control and change order process and negotiations
Portfolio Review
Support biotech, pharma, and CRO clients with comprehensive project review of project portfolio:
- Lead project review for all (or at-risk) projects
- Provide project performance risk assessment and mitigation plans
- Assess projects' financial status including unearned revenue liability and other financial exposure risks
- Identify systemic organizational and infrastructure issues and propose potential solutions
- Identify project team interaction issues and propose potential solutions
Project Rescue Support
Support biotech, pharma, and CRO clients with project rescue services for critical projects that have "gone off the rails:"
- Comprehensive review of at-risk project status
- Full risk assessment
- Resolve challenging or broken team dynamics through introduction of independent external consultant
- Forward-looking approach
- Avoid focus on assigning blame
- Where we are; where we want to go; how are we going to get there
Due Diligence Support for M&A Activities
Support biotech, pharma, and CRO clients with M&A activities:
- Detailed project review of project portfolios
- Financial review of organization
- Contract review
- Risk assessment
- Assessment of IT infrastructure
- Review of SOPs, policies, procedures
- Personnel interviews and reviews
- Comprehensive summary and recommendations
System Implementation
Support pharma, biotech, and CRO clients with implementation or upgrades to computerized systems for clinical research:
- Data management and EDC systems
- Project management systems
- Clinical trials management systems
- Document management systems
- Review System Development Life Cycle (SDLC) approach and validation plans
- Review system concept and project charter
- Review or prepare system specifications and functional requirements
- Review or prepare testing plans
- Provide ongoing risk assessment and mitigation plans
- Prepare Requests for Proposals (RFPs)
- Solicit, receive, and review proposals
- Prepare proposal comparison and make recommendations
- Vendor contract preparation and negotiation
- Vendor management oversight
Project Management Maturity Review
Support biotech, pharma, and CRO clients with assessing project management maturity model and implementing improvements:
- Detailed project review of project portfolio
- Assessment of project management infrastructure
- Review of SOPs, policies, and procedures
- Personnel interviews and reviews
- Review of project management training curriculum
- Comprehensive summary and recommendations