How Diligent Supports Clinical Research Sponsors and CROs

Cut the burden of vendor qualification with Diligent

Now you can find and qualify service providers faster and with less resources.
Free your teams from admin work to focus on other priorities!

The Diligent Qualification Platform helps you through the entire process of identification, shortlisting and assessment of providers of services or technologies that support clinical research.

Saving time in clinical trials with Diligent Pharma

How the Diligent Platform works for clinical research sponsors and CROs

Which services and technologies can you evaluate with the Diligent Qualification Platform?

Diligent helps you to find vendors and assess their quality across 21 different
clinical research service areas.
The list of services covered is always growing:

CRO Functional services and Phase I trial services

  • Clinical Monitoring
  • Data Management
  • Biostatistics
  • Medical Writing
  • Phase 1 CRU
  • Patient Recruitment & Retention (new for 2021)

Technical Services

  • Central Laboratories
  • Medical Imaging
  • ECG
  • Biomarker Laboratories
  • Bioanalytical Laboratories

eClinical and Mobile technologies

  • eHealth Records
  • EDC
  • Electronic Informed Consent
  • Electronic Regulatory Binders (eISF)
  • Mobile HCP visits
  • Wearables/sensors
  • Telemedicine
  • eTMF, IRT, IxRS
  • COA, eCOA
  • Mobile Cardiac Monitoring (new for 2021)

Other Service Categories to be added in 2021-2022

  • Investigator contract budgets and payment
  • Investigational Product (IP) Management
  • Pharmacovigilance
  • Investigator Site Qualification

How can I trust the quality assessments made by Diligent?

Diligent uses a comprehensive set of standards for qualification that were developed by a consortium of 160 service providers and sponsors, all with the goal of improving effectiveness and reducing variability during the vendor qualification process. The qualification standards are dynamic and updated as best practises and global regulatory requirements evolve. There are a set of core standards that apply to all vendors as well as sector-specific standards that reflect the 21 service areas shown above.

The Diligent Qualification Platform service builds on these standards using a risk-based assessment of development program requirements. This innovative approach helps clinical trial sponsors and CROs to manage vendor risk effectively and to document their vendor qualifications as required by global health authority regulations. Outsourcing vendor qualification to Diligent reduces variability and enables improved compliance.

All clinical trial service providers in Diligent complete:

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
21 CFR Part 11 Compliance

4

Operations and Project Management

Data Management and Transfer
Staffing and HR Management
Training
Facilities Management

What Does a Diligent Subscription Include?

When you subscribe to the Diligent Qualification Platform as a trial sponsor or CRO, your entire team has access to the information they need for effective risk and quality management of service and technology providers

  • Full access to the growing repository of 250+ Request for Information (RFI) details, readily available for 100 service and technology Providers
  • Comparison tool to evaluate up to 3 RFIs side by side
  • Ability to request new providers for Diligent team to solicit RFIs
  • Ability to request new Vendor Qualification Assessments (VQAs) and participate in VQAs already scheduled
  • Ability to purchase anonymized VQA reports in the Diligent VQA library
  • Global network of experienced auditors vetted for their expertise in specific technical and therapeutic areas
  • Option to add premium services for customized scoring and study specific audits
  • Unlimited users – access for your entire team
  • Dedicated Account Manager

For more details or a free demo of the platform