Specialty Biometrics Consulting
Supporting small to mid-size pharmaceutical and biotech organizations to achieve successful project execution
Services
Operational Delivery
Ensure optimal execution of project deliverables
- Interviewing and hiring of biometrics resources
- Coordination between interdepartmental stakeholders to ensure the execution of key milestones
- Compliance with ICH, FDA, and GCP standards
- Streamlining operations and process improvement
- Resource planning
- ISS/ISE support
- CDISC standards adoption
- eSubmission support for NDA and BLA filings
Vendor Selection and Oversight
On-side advocacy for vendor qualification, selection, and ongoing management
- RFP Development
- Bid Defense Advocacy
- Executive oversight and proactive monitoring of vendors
- Negotiation and implementation of budgets and budget tools
- Evaluation of pricing and discount schema
- Expansion into lower-cost regions
- Risk management solutions to critical path issues
Infrastructure Development
Create methodologies to collaborate and measure success
- Implementation of and participation in operational and executive governance
- Establishment and implementation of quality metrics, oversight plans, project adoption checklists, communication plans, workflow, process, timeline, resource planning, recruitment, and forecasting tools.
- SOP/WI creation and harmonization