Key Highlights
Gap Analysis
Independent operational assessment
Gap Analysis
Roles Reviewed
Sponsor, CRO and vendor responsibilities
Roles Reviewed
Corrective Actions
Proposed and implemented
Corrective Actions
Cost Control
Closure of a non-recruiting site recommended
Cost Control
Identifying Clinical Operations Gaps to Improve Recruitment and Study Execution
Clarenta conducted an independent clinical operations gap analysis for a Phase I/II dose-escalation study in patients with glioblastoma.
The assessment examined the factors affecting recruitment and study execution, including vendor responsibilities, communication pathways, escalation processes and project-management practices.
The Challenge:
Following several operational difficulties, the Sponsor commissioned an independent review to identify the factors affecting recruitment and reduce the risk of further delays.
The assessment needed to examine:
- Overall clinical study conduct
- Sponsor oversight
- The recruitment strategy
- Responsibilities across the Sponsor, CROs and vendors
- Communication with investigator sites
- Escalation pathways
- Study-status reporting
- Differences in stakeholder expectations
The review also needed to be conducted objectively and diplomatically to encourage stakeholder participation and support acceptance of the findings.
Our Solution:
We implemented a structured clinical operations gap analysis.
Our team:
- Reviewed essential clinical trial documents
- Conducted face-to-face interviews with the Sponsor’s clinical operations team
- Assessed clinical study conduct and Sponsor oversight
- Mapped roles and responsibilities across the Sponsor, CRO and central imaging vendor
- Reviewed communication among the Sponsor, CROs and investigator sites
- Assessed issue-escalation pathways
- Evaluated study-status reporting tools and processes
- Compared stakeholder expectations and identified differences in understanding
- Identified operational weaknesses and priority areas
- Proposed and implemented corrective and preventive actions
The Outcome:
The assessment confirmed effective Sponsor oversight and strong communication with investigator sites.
It also identified several barriers affecting recruitment and study execution:
- Drug-supply shortages were affecting the recruitment strategy
- Vendor roles and responsibilities were insufficiently defined
- Expectations and timelines were not fully aligned
- Communication and project-management processes required improvement
- One site was not recruiting patients
We recommended closing the non-recruiting site to avoid unnecessary costs, realigning vendor expectations and timelines, clarifying responsibilities and strengthening communication and project-management processes.
The assessment provided the Sponsor with a clear, prioritized action plan and led to further collaboration on clinical operations improvements.