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Novotech CRO Qualification Package

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Veeva Systems

Diligent Pharma is an independent Quality and Compliance organization that qualifies clinical vendors on behalf of its Pharma and Biotech clients. After Diligent audits a vendor, we make their Qualification Package available to our entire client base through our technology platform instead of having to audit the same vendor multiple times per year.

Qualify Novotech Today

Diligent Pharma has qualified Novotech through a rigorous, multi-day assessment led by expert auditors. The Novotech Qualification Package – the qualification audit report, audit agenda, and auditor’s credentials – is managed on the secure Diligent platform and can be shared with any Sponsor at no cost.

Accepted globally by Health Authorities, the Diligent model – the secure use of centralized qualification data – allows Sponsors to quickly qualify and onboard Novotech in days instead of having to wait months to secure a place on their audit calendar.

Recent Assessment Dates: November 2024 and February 2025

The following capabilities were assessed:

Core Capabilities

  • Organization
  • Financial Stability
  • Insurance
  • Ethics/Anti-Bribery/Anti-Corruption
  • Privacy & Personal Data Protection
  • Facilities Management
  • Staffing & Human Resources Management
  • Training
  • Quality & Project Management
  • Risk Management
  • Third-Party Quality Management & Oversight
  • Computer Systems / 21 CFR Part 11 Compliance

Clinical Services

  • Biostatistics
  • Clinical Monitoring
  • Clinical Data Management
  • Investigator Site Budget Contracts
  • Medical Monitoring
  • Medical Writing
  • Pharmacovigilance
  • CRO Project Management
  • TMF/eTMF

The Audit Report is an independent assessment that also includes the current status of Audit Observations and CAPA commitments (if applicable).

Client request

1. Complete the form below. No payment is needed.
2. Your request will be approved by Novotech. On approval you will be emailed a secure link with access to the Qualification Package.

Veeva Systems

  • Terms of use:

    These terms of use apply to the request and download of the Novotech Qualification Package. The person checking that they "agree to the terms of use" represents that they have the authority to act on behalf of, and to bind the named Requesting Organization ("Requestor") to these terms of use.

    The Requestor agrees that they will download and use the Qualification Package for the Requestor's internal business purposes only and will maintain the Qualification Package as confidential and not disclose it to any third parties.

    The Requestor may not distribute or permit copies of the Qualification Package to be used for any other purpose.

  • This field is for validation purposes and should be left unchanged.

Questions?

Diligent Client Support:
Peter Haessig
Director, Client Partnerships
Diligent Pharma, Inc.
179 Nassau Street, Suite 3A,
Princeton, NJ 08542
E: peter.haessig@diligentpharma.com
T: +1 973-713-8242