PRIVACY

Please note, the Privacy page has bee updated as of Feb 3, 2025, along with updates to privacy and legal documents. Click here for the prior privacy page.

Products & Design | Privacy Policies & Agreements | Data Protection | GDPR

Trial By Fire Solutions is an eClinical software company focused on Clinical Trial Management System (CTMS) end Electronic Trial Master File (eTMF) solutions that improve planning, execution and tracking of clinical trial activities.

We take the security and privacy of your data and our infrastructure very seriously. Our commitment is to provide an environment that is safe, secure and available to all of our customers and website visitors.

Our SimpleTrials CTMS and eTMF application is offered as commercially available cloud-based SaaS solutions. Additional details about the product and offering can be found at www.simpletrials.com. SimpleTrials is utilized worldwide on a daily basis via established web browsers.

The SimpleTrials product is designed with global clinical studies in mind. Individuals who utilize our application as licensed users do so with specific purpose, training and experience. They are authorized for accounts through their organizations who directly contract with Trial By Fire Solutions.

• Our product features support management of data related to contact records, timelines, site and subject tracking, workflow processing and file uploads for studies being managed by our clients.

• Our clients input data into our product and are responsible to obtain the necessary consent for collection of personal data for individuals that are participating in clinical trials but are not product users.

• We do not display third party advertising within our websites or applications nor do we sell or share user data with advertisers.

• We make no effort to track your activity when you are not using our websites or services. We only use data entered to support the products and services we provide.

• Our simplistic design elements support clinical study tracking needs without collecting more data than is necessary to support the business needs of our client.

• Established user roles and sensible data view options provide clients with appropriate levels of transparency and accountability for data viewing and edit permissions by their product users.

• Technical controls for 21 CFR Part 11 compliance come standard.

PLEASE NOTE: Policies have been updated in Feb 2025. See the change summary and new policies here.

The following policies are tailored for the different ways personal information is collected from individuals who visit our website and those that utilize our CTMS and eTMF services or otherwise interact with us.

• Privacy Notice for Visitors - addresses information we collect when you visit our simpletrials.com and simplectms.com websites and in offline sales and marketing activities.

• Cookie Policy – please reference the Privacy Notice for Visitors

• Privacy Notice for SimpleTrials Subscribers – addresses privacy practices with respect to data collected from you or generated when you use our SimpleTrials product and services.

• Terms of Use – applies to all licensed users. This is accepted by each user to access the client server upon initial activation of their account and as updates apply.

• Master Services Agreement - applies to the subscribing client organization. This MSA establishes the business needs and contractual details for the client engagement to utilize our CTMS and eTMF.

• Data Processing Agreement (DPA) - applies to the SimpleTrials product as an addendum to the Master Services Agreement.

For questions about Data Privacy for SimpleTrials, please contact us.

Trial By Fire Solutions is a US based company with data safely retained in the United States. Our goal is to provide our clients with secure, fast and reliable service. Our websites and applications are accessed globally from the internet. As the data controllers, we expect our clients to have the proper policies and protections in place with their SimpleTrials users regardless of their location.  

Trial By Fire Solutions has sufficient organizational and technical controls in place to support data transfer, processing and privacy needs for our clients. This means that clients may invite their team members in different geographic locations to create SimpleTrials user accounts. This also means that SimpleTrials users may input personal data for persons located in any geographic location and continue to utilize the SimpleTrials application per the designated business need.

In all cases, the client owns the data input into our SimpleTrials applications by their users. We process personal data via other organizations to help provide the service given the established business need. The sub-processors we authorize to process client data for our SimpleTrials services are further described in the Terms of Use.

GDPR is an opportunity to build a stronger data protection foundation for the benefit of everyone. Trial By Fire Solutions is committed to ensuring compliance with GDPR requirements. This includes our commitment to helping our customers stay in compliance with GDPR and their local requirements.

As part of this commitment, we have updated our Privacy Policies for Subscribers and Privacy Policies for Visitors. In addition, here are a few things that Trial By Fire Solutions is committed to doing to ensure our compliance with GDPR and that of our SimpleTrials clients:

• We commit to adhering to appropriate safety measures and precautions in accordance with GDPR.

• We will ensure that our personnel authorized to process personal data have committed to confidentiality.

• For new features and enhancements, we’re applying Data by Design principles of GDPR.

• When we transfer data outside of the EU, we commit to having the appropriate data transfer mechanisms in place.

• We will ensure that subprocessers, including data center partners, which handle personal data are held to the same data management, security and privacy practices and standards that we ourselves follow.

• We will assist our customers in responding to data subject requests they may receive under the GDPR.

• We will assist in notifying regulators of data breaches and providing prompt communications to customers and users.