ENGAGEMENT IMPROVES TRIAL SUCCESS

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The increased reliance on decentralized clinical trials creates a greater need for true digital patient engagement. When trial participants better understand trial protocols and associated risks and benefits and have a meaningful consent conversation where their questions and concerns are addressed, that engagement can favorably impact participant conversion, protocol adherence, and retention rates. And 5thPort is digital, simplifying consent related audit and regulatory compliance.

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Patient drop out rates increase the cost of clinical trials. 85% of studies fail to retain enough patients. The average patient dropout rate across trials is 30%. These statistics come from a study by Dan Stempel in 2018 titled 'How eConsent is Changing Clinical Trials'.
The 5thPort effect ensures that you as a patient were informed, that you understood the information, had the opportunity to ask questions and that your questions/concerns were addressed.
Increase trial efficiency while reducing trial cost with 5thPort. Engage patients remotely leveraging multimedia components and freeing up clinical research associate time. Eliminate paper and error-prone manual processes related to patient engagement and informed consent. Reconsenting is simple and completely automated. Eliminate expensive informed consent related audit findings.
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). Entire patient encounters are digitally documented in great detail and are always accessible to research staff. The Platform ensures that patients always interact with the latest version of the engagement content - this includes consent forms. Conversational consent process allows research associates to obtain a meaningful informed consent.
Overwhelmed woman looking through litigations regarding non-compliance. 5thPort's platform is compliant with FDA CFR 21 Part 11 to mitigate that.
Overwhelmed woman looking through litigations regarding non-compliance. 5thPort's platform is compliant with FDA CFR 21 Part 11 to mitigate that.
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). Entire patient encounters are digitally documented in great detail and are always accessible to research staff. The Platform ensures that patients always interact with the latest version of the engagement content - this includes consent forms. Conversational consent process allows research associates to obtain a meaningful informed consent.
Enhance your brand and your relationship with your sites and patients by white-labeling the 5thport informed consent platform; including the addition of a custom URL. Manage all your trials from one central platform presenting your sites and patients with a consistent and engaging experience. Pricing options include per trial or enterprise level.

A PLATFORM DESIGNED SPECIFICALLY FOR YOU

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With a configurable workflow and rich content management capabilities, 5thPort’s patient engagement and eConsent software was designed specifically for Contract Research Organizations (CRO’s), sponsors, research institutions, sites, pharmaceutical, and biotech companies managing clinical trials.

For CTMS, eSource, EDC, ePro or eCOA solutions used in clinical research, 5thPort can be white-labeled and integrated as an add-on to increase the value of your offering.