Resource & Vendor (CRO) Management Plan — GLPI-103
| Field | Value |
|---|---|
| Document ID | PM-006 |
| Version | 1.0 |
| Standard | ICH E6(R3) (sponsor oversight of delegated activities) |
| Confidentiality | Confidential — portfolio use |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Project Management | Initial vendor/resource plan |
1. Outsourcing Strategy
Core sponsor functions (strategy, RA, PV signal management, decision-making) are retained; operational delivery is delegated to qualified vendors under sponsor oversight (ICH E6(R3)).
2. Vendors (illustrative)
| Function | Vendor type | Key oversight |
|---|---|---|
| Clinical operations / monitoring | CRO | Monitoring KRIs/QTLs (TMF-CMP); issue escalation |
| Central laboratory | Lab vendor | Assay validation; sample logistics |
| IWRS / EDC | eClinical vendor | Randomization integrity; data capture (TMF-RAND/DMP) |
| Biostatistics / programming | CRO/FSP | SAP execution; QC of derivations |
| Drug supply / packaging | CMO | GMP supply; double-dummy blinding |
| Pharmacovigilance | PV vendor | Case processing; expedited reporting (TMF-SMP) |
3. Oversight
Qualification/selection, contracts and quality agreements, KPIs, governance meetings, and audits. Non-delegable sponsor responsibilities are retained. Vendor issues feed the Issue/CAPA log (QA-ISSUE).
4. Resources & Budget
Staffing and external spend are reflected in the program budget (PM-003) and timeline (PM-002).