Two scientists analyzing data on laptop together
Decorative geometric squares background patternDecorative geometric squares background variant

Post Market Surveillance Software

Streamline your clinical trial by using our cloud-based post market surveillance system to conduct post-market surveillance. Like our EDC, our PMS increases efficiencies for post market surveillance and allows for our clients to conduct their Phase IV requirements.

Datatrak is dedicated to empowering our clients with a cloud-based pharmacovigilance software solution that makes collecting trial data as simple as possible. Our goal is for our clients to have efficient and successful studies by using a platform made specifically with them in mind.

Request a Demo
Trusted by
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

Innovative Reporting

Powerful reporting gives study teams the ability to easily access, filter, and export real-time study data into clear and concise reports whenever they are needed.

Extensive Trial Design Capabilities

Work with our team of Trial Designers to create the study as needed to improve and enhance the end user experience.

Easy Mid-Study Change Implementation

We take pride in our one-of-a-kind process that can allow teams to implement changes without any required study downtime or data migration.

Post Market Clinical Follow-Up

A Simpler Approach to Medical Device Post-Market Surveillance

Whether you’re managing drug safety surveillance or medical device post-market surveillance, Datatrak’s cloud-based platform simplifies data collection, reporting, and compliance — so your team can focus on what matters most.

See How It Works
  • Green checkmark icon for feature list

    Cloud-based PMS platform built for Phase IV and post-market studies

  • Green checkmark icon for feature list

    Real-time reporting: access, filter, and export study data on demand

  • Green checkmark icon for feature list

    Implement mid-study changes without downtime or data migration

  • Green checkmark icon for feature list

    Supports post market clinical follow-up and regulatory compliance

Integrated Solutions

View All Solutions

Electronic Data Capture (EDC)

A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.

Clinical Trial Management (CTMS)

Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.

Electronic Trial Master File (eTMF)

Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.

eConsent

Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.

Post Market Surveillance

Conduct post-market surveillance and Phase IV studies with a cloud-based pharmacovigilance software platform built for compliance.

EMR/EHR

Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.

Trial Design

Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.

Data Management

Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

Decorative geometric squares background patternDecorative geometric squares background pattern

"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology therapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intuitive 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. The system is easy to use, you can create customized forms, manage study participants, securely 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 friendly, and site staff 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

Frequently Asked Questions

What is post market surveillance?

Post market surveillance is the ongoing process of monitoring the safety, performance, and real-world use of a drug or medical device after it has been approved and made available to patients. Datatrak’s cloud-based PMS platform helps sponsors and CROs conduct their Phase IV requirements, with the same reporting and configuration capabilities teams rely on in our EDC.

How does Datatrak support medical device post market surveillance?

Our cloud-based platform simplifies data collection, reporting, and compliance for medical device post-market surveillance, including post market clinical follow-up studies. Teams can implement mid-study changes without downtime or data migration, and powerful reporting gives study teams the ability to easily access, filter, and export real-time study data into clear and concise reports whenever they are needed.

Why is post market surveillance important for drug and device manufacturers?

Post market surveillance is how manufacturers detect safety signals, confirm long-term performance, and maintain regulatory compliance once a product is in widespread use. Whether you are managing drug safety surveillance or medical device post-market surveillance, Datatrak’s platform brings Phase IV data collection, reporting, and compliance into a single configurable workflow so your team can focus on what matters most.

Tell us what you're trying to solve, and we'll show you how we can help.

Patient wearing EEG cap during clinical study