FAQs

Pharmaceutical

Who is your target customer?

Pharmaceutical companies, Biotech companies and medical device manufacturers

Describe how the product generally works?

Using our proprietary ConsentNowTM software, the patient watches a series of videos (animation, live footage or a combination of both) on a tablet or via an Internet web portal at the clinical site. We create the video animations based on a script derived from the sponsor’s supplied protocol after the script has been approved by the IRBs/ECs. In between each video segment we ask the patient several questions to evaluate their comprehension and retention level before advancing them to the next video segment. We can provide these videos in multiple languages for any study; a key to providing true informed consent in a diverse population.

After reviewing all the videos and answering all of the questions we present the patient with the actual Informed Consent Form (ICF) on screen for review. As the patient goes through the ICF page-by-page we have a built-in customizable dictionary (supports study specific words) to assist their comprehension. If a user still has a question they can type their question directly into the ConsentNowTM software application to review with the physician or study nurse prior to signing the consent form. The patient cannot move on to signing the consent form until all questions are answered to their satisfaction.

Do you provide training and how do you control access to the software?

We typically recommend that the clinical investigators be introduced to our ConsentNow (eICF) product at an investigator meeting. This allows for a more comprehensive overall understanding of the product and an opportunity for one-on-one discussion along with the training.

Prior to site startup we provide and offer online or onsite training to clinical staff. At that time they are provided with all the necessary credentials to access the platform. The product is intuitive so training is usually completed in a one hour session. Continual support and additional training are part of our commitment to each project.

Are there ways to contact participants whenever there are changes to the consent form?

Yes, when there is a change to the consent form a notification goes to the clinical staff in the form of an email notifying them which patients need to be re-consented. If the change has an impact on the videos they will be updated centrally within a web based portal and pushed to any remote devices. Only the latest version will be available for review. The sponsor and site can generate reports from the portal showing which patients have completed the process.

What data encryption services does your product use?

Secure Sockets Layer ‘SSL’, a Cipher suite of cryptographic protocols designed to provide communications security over a computer network.

Does the product have security measures in place to protect patient information?

Yes, patient information is not stored locally on any devices. All information is stored on our dedicated server behind a secured firewall.

Is your product available on mobile platforms and/or the web?

Yes, the product is available on Android, Windows and iOS platforms as well as the web.

Ready to see the next generation of Informed Consent?

We would be delighted to provide you with a demonstration.
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