How Diligent supports Quality Management in clinical trials

Proper selection, management and oversight of GCP/GCLP service providers is critical for safety and compliance in clinical trials, so it’s vital to research all vendors fully and assess the risks of working with them.

Here’s how the Diligent Platform supports Quality Assurance in clinical trials, helping you to comply with GCP and global regulatory requirements.

Using the Diligent Qualification Platform, clinical trial sponsors have:

  • Rapid access to details of service providers’ capabilities and resources through answers to RFI (Request for Information) questions focused on our Qualification Standards.
    We currently have over 250 completed RFI questionnaires available for over 100 service providers ready for you to use.
    These RFIs are based on a set of 22 industry agreed standards, developed and kept up to date by a consortium of 170+ trial sponsors and service providers.
  • A standardized approach to Vendor Qualification Assessment (VQAs) using the same industry-leading standards and a global network of experienced quality auditors.
  • A unique online comparison tool to evaluate up to 3 RFIs side by side.
  • The ability to request detailed RFI information for new providers – we approach service providers on your behalf, issue RFI questions, chase progress and review responses.
  • The ability to participate in VQAs already scheduled saving time and money.
  • The ability to request vendor qualification assessments for new service providers with whom your team is interested.
  • The ability to purchase anonymized reports from existing VQAs in the Diligent VQA library, saving even more time.
  • RFI and VQA Scoring Premium Service – We can serve as an extension of your staff by qualitatively evaluating providers against our qualification standards for your teams by evaluating VQA reports or RFI answers to “score” the relative risk areas of importance for your company. Our Scoring Premium Service can help you focus your attention on the highest areas of risk as you build your vendor risk management plans.
  • A dedicated Account Manager to ensure we meet your needs.

Outsourcing vendor qualification to Diligent reduces variability and enables improved compliance.

Benchmark your suppliers against industry-leading standards

Every supplier in the Diligent Platform completes the rigorous RFI core standards developed by the Avoca Quality Consortium.

 

For a comprehensive understanding of the capabilities and processes of clinical trial service providers, each supplier in the Diligent Platform has provided their details for:

1

Organizational standards

Financial Stability
Insurance Standards
Ethics/Anti-Bribery/Anti-Corruption

2

Quality Management Systems

Third-party Quality Management and Oversight
Document Management and Control
Risk-based Quality Management Systems

3

Privacy and Personal Data Protection

Computer Systems Validation
Data Privacy & Protection
21 CFR Part 11 Compliance

4

Operations and Project Management

Data Management and Transfer
Staffing and HR Management
Training Process & Record Keeping
Facilities Management

Use our existing network of experienced Quality Auditors

We maintain a global network of over 30 auditors to qualify service providers on the Diligent Platform against industry-leading standards. All our auditors have extensive experience of the clinical research industry including at least 10 years’ QA Auditing experience.

Hear the common-sense perspective of our quality auditors in our recent free webinar, How to Get the Best from Supplier Audits.

Diligent enables you to evaluate all service providers on a single platform

The RFI/VQA standards that we use cover the latest technologies for clinical research, including wearables, eHealth records and eSource.

CRO Functional & Phase I Services

  • Clinical Monitoring
  • Data Management
  • Biostatistics
  • Medical Writing
  • Phase 1 CRU
  • Patient Recruitment & Retention
  • Investigator Contract Budgets & Payments
  • Pharmacovigilance

Technical Services

CRO eClinical Core Standards

eClinical and Mobile Technologies

  • eHealth Record to EDC connector
  • Electronic Informed Consent
  • Electronic Regulatory Binders (eISF)
  • Mobile HCP visits
  • Wearables/Sensors including Actigraphy
  • Telemedicine
  • eTMF
  • IRT/IxRS
  • COA, eCOA
  • Mobile Cardiac Monitoring

Upcoming RFI Categories

  • Investigational and Medicinal Product Management
  • Investigator Site Qualification
  • Mobile Biomarker Sensors
  • Mobile Respiratory Sensors

For a no-obligation discussion about how the Diligent Qualification Platform could support compliance and quality management for your clinical trials contact george.parrish@diligentpharma.com or complete this form: