Improve Clinical Trial Efficiency and Retain Participants2023-05-18T16:08:24+00:00

Retain participants and improve compliance at a lower cost

5thPort helps accelerate trials and improve study success by combining digital engagement and eConsent – all in one place. We create effortless participant and staff experiences, simplify trial operations, and maximize workforce efficiency.

Supports

  • Sponsors
  • Contract Research Organizations
  • Research Institutions
  • Research Sites and Site Networks
5thPort accelerate trials with digital engagement and eConsent all in one place - Woman engaged on mobile phone

Reduce compliance risk

No more incorrect, incomplete, altered
or lost consent forms.

5thPort captures every action on the platform with a digital date/time stamp for bullet proof documentation. The platform ensures that participants always interact with the latest version of engagement content including consent forms.

The completed consent forms are available digitally (PDFs) for download at any time during your trial, and all consent forms for the trial can be downloaded for your records when the trial is complete.

5thPort is externally validated and in compliance with 21 CFR Part 11, EU Annex 11, ICH-GCP (electronic records and signatures) and HIPAA (security and encryption).

With the click of a button, our One Touch Compliance™ report gives researchers the detailed information required for audit processes.

SEE HOW
Standard patient eConsent - Informed Consent General Information - 5thPort digital eConsent
5thPort platform is HIPAA Compliant - FDA 21 CFR Part 11 - EU Annex 11 - ICH-GCP
5thPort expands global access to trials - Nurse holding an IPAD 1298 x 1926

Increase trial efficiency

Save staff time.

The digital engagement protocol will eliminate repetitive conversations with each of your consenting participants and deliver consistent standardized messaging.

To facilitate better access to educational material, users can choose to receive communication about their engagement plan via SMS and/or email. Re-consenting is a simple and completely automated process.

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Better manage clinical trials

Gain visibility and oversight with centralized study management capabilities.

Get real-time monitoring of all consent activities within a single dashboard. Review and analyze enrollment results across all participating sites and researchers.

Centrally manage all consent and engagement artifacts. Version control and automated re-consenting ensures every participant is signing the right version of the consent every single time.

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5thPort admin access & multiple clinical trial sites participant engagement
Woman holding an IPAD - Audit inspection are easy and always digital ready with 5thPort

Inspection audit ready

Stress-free compliance with automated processes.

Let’s face it, keeping track of paper consent forms is no fun, especially when faced with an audit. 5thPort captures every action on the platform with a digital date/time stamp for bullet proof documentation.

Quality role specific functionality lets QA personnel review and audit consent and re-consent forms for stress free compliance.

The completed consent forms are available digitally (PDFs) for download at any time during your trial, and all consent forms for the trial can be downloaded for your records when the trial is complete. Reconsenting is a simple and completely automated process.

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Frequently Asked Questions (FAQs)

How simple is it to set my study?2023-05-15T16:33:08+00:00

Set up is an easy, one-time activity that can be done as soon as Study Activation and the Informed Consent Engagement is ready.

Can I use my own consent forms?2023-05-15T16:34:13+00:00

Yes. Upload your IRB approved consent form or use our template to configure various fields and recreate your own.

Does 5thPort support integration to other systems?2023-05-15T15:26:06+00:00

Yes. 5thPort can integrate with any clinical trial management system, EHR or EMR with ease. Save time and ensure patient info accuracy leveraging your “source of truth”.

My trial has multiple sites with different jurisdictions. Can 5thPort support multiple IRB’s for a single study?2023-05-15T16:35:14+00:00

Yes. 5thPort can easily support multi-site trials. The system can be configured to allow the PI or study manager to set up the trial and also determine the necessary staff across different sites who would be eligible to participate in the trial. 5thPort is designed to be used AFTER an IRB approval is obtained. The system can be set up to allow each trial site to have its own settings and branding. Additionally, different IRB requirements can be supported for the same study.

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