Signant Health Qualification Package

Qualify Signant Health today, no payment required.

Terms of use:


These terms of use apply to the request and download of the Signant Health 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.

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Terms of use:


These terms of use apply to the request and download of the Signant Health 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.

Page 1 / 1

Terms of use:


These terms of use apply to the request and download of the Signant Health 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.

Page 1 / 1

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Faded Diligent Logo for Hero Background
Faded Diligent Logo for Hero Background
Signant Health
Signant Health

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.

Diligent Pharma has qualified Signant Health through a rigorous, multi-day assessment led by expert auditors. The Signant Health 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 Signant Health in days instead of having to wait months to secure a place on their audit calendar.

Recent Assessment Dates: May 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

SmartSignals Platforms

  • SmartSignals Unified Platform

  • Data Management (United Platform)

  • SmartSignals RTSM

  • SmartSignals Telemedicine

  • TrialMax

  • Project Management (United Platform)

  • SmartSignals Supplies

  • SmartSignals eConsent

  • Cognitive Drug Research System (CDR) - eCOA

RaterStation

  • Rater Station - eCOA

  • Rater Training

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

Frequently Asked Questions

1. I’m used to hiring a consultant auditor to conduct qualification audits. What if I want to stick with my process?

Diligent Pharma’s process is the same as hiring an independent consultant auditor.  We see no reason to audit Signant Health countless times per year on behalf of every client and waste their money.

ICH E6 (R3) leaves the qualification method up to Sponsors. Think of Diligent as an independent auditor that works on behalf of multiple Sponsors, simply allowing them all to use the results of a single audit an d saving all parties valuable time and money in the process.

After your review of the audit report, Signant Health will still support and answer any follow-up questions you may have to ensure the process is completed to your satisfaction.

2. In order to accept the audit report, I must qualify Diligent Pharma. Can I do that?

Yes. Diligent will provide you with a completed Core Qualification Questionnaire and enable access to any SOPs, Policies, or technical documentation you require immediately.

3. Why should I trust the quality of Diligent Pharma’s work?

The FDA has inspected Diligent Pharma’s clients many times and has reviewed their use of the Diligent Platform, deeming it a compliant way to qualify vendors.

Our company has been in business since 2017, and several of the largest pharmaceutical companies in the world – with some of the most stringent quality standards and expectations – are longtime clients. We are happy to provide client references upon request.

Each auditor has 10+ years of GxP auditing experience and appropriate technical expertise

Have more questions?

If you have any questions about our Signant Health audit, please reach out to our team using the details below:

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