Vendor Oversight

Services

Data Integrity with Comprehensive Vendor Oversight and QC Services

Harbor Clinical understands that while a sponsor can transfer trial related duties to a CRO, the sponsor maintains the ultimate responsibility for the quality and integrity of clinical trial data. Harbor Clinical’s vendor oversight services are structured to incorporate quality control throughout the process, overseeing QC checks at each step of data handling to ensure success. We subscribe to the motto “an ounce of prevention is certainly worth a pound of cure!”

Harbor Clinical Provides

Vendor Selection and Qualification

Choose vendors based on their expertise, experience, and compliance with regulatory standards.
Contractual Agreements

Establish clear contractual agreements outlining responsibilities, timelines, deliverables, and quality standards.
Performance Monitoring

Regularly assess vendor performance against predefined KPIs, KQIs, metrics and benchmarks.
Quality Assurance

Implement processes and Quality Agreements to ensure vendors adhere to Good Clinical Practice (GCP) guidelines and other regulatory requirements.
Communication and Governance

Maintain open and transparent communication channels with vendors to address issues promptly and facilitate collaboration.
Risk Management

Identify potential risks associated with vendor activities and develop mitigation strategies to minimize their impact on the trial.
Documentation

Maintain comprehensive documentation of all vendor-related activities, including agreements, communications, and performance evaluations.

Explore Our Services:

Functional Service Provision

Functional, Flexible, and Fractional. Harbor Clinical provides a broad portfolio of services across the clinical development lifecycle.

GxP Auditing

Harbor Clinical’s team of GxP auditors is available to help you plan, schedule, manage, and conduct your site/vendor audits.

Services

Data Integrity with Comprehensive Vendor Oversight and QC Services

Harbor Clinical Provides

Vendor Selection and Qualification

Contractual Agreements

Performance Monitoring

Quality Assurance

Communication and Governance

Risk Management

Documentation

Explore Our Services:

Functional Service Provision

GxP Auditing