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Ockham’s Structured Assessment process is staged as follows:
I. Initial Program (Protocol) Assessment
- Sponsor Status with Program (protocol complete, drug available, etc.)
- Protocol Feasibility (Primary Efficacy, Inclusion/Exclusion, etc.)
II. Site and Patient Assessment
- Availability and Type of Sites (who and what type; academic/non-academic)
- Potential Enrollment Rates
- Logistic Challenges
- Investigators Assessment of Protocol
- Potential Site Budgets
- IRB (Central/Local)
III. Sponsor Working-Practice Assessment
- Sponsor Site Contract Process
- Site Selection and Approval Process
- Document Approval Process
- Materials Transfer Methodology (Documents, Data, etc.)
- Drug Availability/Shipment Logistics
IV. Detailed Program Specifications
- Detailed Parameters for Proposed Work, including:
- Number of Sites, Monitoring Frequency/Duration, CRF Pages, Number of Tables/Listings, etc.
- Project Team and Labor Allocation |
It should be noted that in addition to setting benchmarks, Ockham uses these materials to generate comprehensive proposals.
Once the structured assessment process and benchmarks have been set (internal and external), all elements are embedded into a detailed Project Plan. Ockham’s approach to management and compliance to these benchmarks is to build for each key metric (and corresponding benchmark) a Contingency Plan that specifically outlines activities associated with measured performance against targets. This plan is embedded into the overall Project Plan, reviewed and amended as necessary during all phases of the program.
Back to the Ockham Method
Review “Critical Success Factors” |
