Method
Internal Benchmarks as Part of the Ockham Method
Ockham uses “internal” benchmark performance standards and metrics for key clinical study management activities. The specification of “internal” benchmarks is carefully linked to Ockham’s methodology of project assessment, the central element in Ockham’s approach.
Ockham’s overall approach to performance benchmarks is to begin with a careful qualification and assessment of the target project/protocol and Sponsor company procedures and working practices (see program outline below). This approach yields an analysis of the overall project with respect to benchmarks and timelines, while providing a context for joint planning and gap analysis.
Outlined in the following table is a set of internal performance benchmarks associated with key clinical trials metrics. These are the expectation and performance standards for the Ockham Team. Several of these benchmarks are driven by underpinning assumptions that may be project-related. These benchmarks and associated metrics are always agreed upon at the initiation of a project and serve as management mileposts during execution.
Overall Metrics |
Benchmark |
| Sites Enrollment Ready: Number of days from first Qualification Visit until all sites enrollment ready. | Non-Academic Sites: 6-8 weeks Academics Sites: 3-4 months |
| Database Lock: Number of Days from subject-last visit until database lock. | Paper-Base: 5-6 weeks EDC: 2-3 weeks |
| Tables and Listings: Number of Days from database lock until final tables and listings | 2-3 weeks |
| Clinical Study Report: Number of Days from database lock until final clinical study report; | 4 weeks |
Administrative Benchmarks |
Benchmark |
| Initial “CRO” Contract Negotiation: Number of Days for Ockham Contract Revision | 48 hours |
| Site Contract/Budget Negotiation: Number of Days for Contract/Budget Revision by Ockham | 2-3 days |
Clinical-Medical Benchmarks |
Benchmark |
| IRB Approval: Number of days from IRB Submission to IRB Approval | Local: 4-6 weeks
Central: 5-7 days |
| Sites Enrollment Ready: Number of Days from - Qualification Visit to Site –Enrollment Ready | Non-Academic: 6-8 weeks
Academic: 3-4 months |
| CRF Query Process: Number of Days CRF Reviewed to Query Issued | 5-6 days |
| CRF Query Process: Number of Days from Query Issued to Query Resolved | 2-weeks |
| CRF Retrieval: Number of Days from subject visit to CRF in-house | 2-3 weeks |
Data Management Benchmarks |
Benchmark |
| CRF Entry & Processing: Time from CRF received in-house until pages entered and processed (updated into database) | Within 48-72 hours |
| Database Lock: Number of days from last query resolved until database lock | 1 week |
Biostatistics/Medical Writing Benchmarks |
Benchmark |
| Tables and Listings: Number of days from database lock until final tables and listings | 2-3 weeks |
| Clinical Study Report: Number of Days from database lock until final CSR | 4 weeks |
