Method

Structured Assessments as Part of the Ockham Method

Ockham sets the bar for performance to ensure that standards are met. Ockham’s overall approach to performance benchmarks is to develop for each potential project a structured assessment. Supporting this process Ockham maintains, within specific therapeutic areas, technical/development summaries (see Ockham Technical Synopsis) that guide its assessments of protocols and development plans. Together these yield an analysis of the overall project with respect to feasibility, benchmarks and timelines, providing a context for joint planning and gap analysis.

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.