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Clinical Trial Solutions for Sponsors

Sponsors need visibility, control, and confidence at every stage of a trial. Datatrak gives you real-time oversight across all your sites, automated workflows to cut manual effort, and a compliance framework built to eliminate compliance risks before they become problems. One platform. Every stakeholder. Total control.

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Precision for Medicine company logoClinCloud clinical research company logoQOL Holdings healthcare company logoApo Plus Station pharmacy logoTailrd Heart clinical research logoBausch and Lomb eye health logoSyneos Health clinical research logoStryker medical device company logoPfizer pharmaceutical company logoGilead Sciences pharmaceutical logoMerck pharmaceutical company logoNovartis pharmaceutical company logo
Precision for Medicine company logoClinCloud clinical research company logoQOL Holdings healthcare company logoApo Plus Station pharmacy logoTailrd Heart clinical research logoBausch and Lomb eye health logoSyneos Health clinical research logoStryker medical device company logoPfizer pharmaceutical company logoGilead Sciences pharmaceutical logoMerck pharmaceutical company logoNovartis pharmaceutical company logo
National Cancer Center Japan logoAmgen biotechnology company logoRoche pharmaceutical company logoTaisho Pharmaceutical company logoAbbott Laboratories healthcare company logoSanofi pharmaceutical company logoAllergan pharmaceutical company logoAbbVie pharmaceutical company logoGalderma dermatology company logoGilead Sciences pharmaceutical logoBayer pharmaceutical company logoTeva Pharmaceutical Industries logo
National Cancer Center Japan logoAmgen biotechnology company logoRoche pharmaceutical company logoTaisho Pharmaceutical company logoAbbott Laboratories healthcare company logoSanofi pharmaceutical company logoAllergan pharmaceutical company logoAbbVie pharmaceutical company logoGalderma dermatology company logoGilead Sciences pharmaceutical logoBayer pharmaceutical company logoTeva Pharmaceutical Industries logo

Oversight Without the Overhead

Running a multi-site trial means keeping a close eye on documents, data, and timelines all at once. Datatrak automates and controls site document workflows so nothing slips through the cracks. From study startup through closeout, you have audit-ready access to everything you need, with no scrambling at inspection time. Trusted by global sponsors in over 83 countries across more than 10,000 studies.

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FDA CFR 21
Part 11
Compliant
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HIPPA
Compliant
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GDRP
Compliant
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GCP
Compliant
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SOPs
Validated Systems
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CDISC &
CDASH
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SOC
Type II

Real-Time Trial Oversight

Get a live view into site performance, data quality, and study milestones. Datatrak puts sponsor-level visibility directly in your hands, so you can catch issues early and keep your trial on track.

Automated Document Workflows

Stop chasing signatures and tracking version histories by hand. Datatrak automates site document workflows, keeping every file organized, timestamped, and traceable from submission to approval.

Built-In Compliance Controls

Validated as FDA CFR 21 Part 11, HIPAA, GDPR, and GCP compliant, our platform carries the weight of regulatory requirements so your team doesn't have to. Inspection-ready from day one.

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35+ years

of combined experience

10,000+ studies

managed by Fountayn

83+ countries

using Fountayn

"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology terapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intiutive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. They system is easy to use, you can create customized forms, manage study participants, securly store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user frienidly, and site stasff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

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