Capture and Deliver your Data with Higher Quality  DATATRAK EDC & Medical Coding gives you higher quality data faster utilizing user-friendly and powerful tools. With unprecedented control in an easy-to-use interface, EDC & Medical Coding supports the specific data needs of each trial, providing unparalleled insight to the status of your trial. Most importantly, why change vendors throughout the drug program? Our platform is easily scaled and adapted to match any protocol for drug, device and diagnostic studies. API functionality gives you the ability to connect our EDC with outside programs or processes for maximum trial optimization.  Electronic Data Capture (EDC) Powerful Reporting Capabilities DATATRAK features powerful and innovative reporting capabilities, allowing study team members to easily acces, filter and export real-time study data into clear and concise reports, whenever they are needed. Users can run standard and ad-hoc reports, and export the information they want, when they want it. Additionally, data and metadata listings can dynamically be created by filtering through the managers. Unique to the DATATRAK solution is the ability to be linked from the report, directly to the eCRF, enabling study team members to access the source of the data with a single click. Easy Mid-Study Changes More than ever, clinical studies are becoming increasingly complicated and the likelihood of making unforeseen study modifications is all too common, no matter how well the study team prepares. Implementing mid-study changes can be challenging if eClinical architecture is not capable of such agility. DATATRAK ONE implements mid-study changes with no required study down time, no movement of study data, an optimized implementation timeline, all while reducing risk. Case Study: Mid-Study Change Implemented with no Downtime >> Medical Imaging Capture and Workflow Medical Imaging Capture by DATATRAK allows for the analysis and annotation of image data, including the version controlled images, to be processed into DATATRAK's EDC platform. Whether you are utilizing CORE lab services, or conducting internal scientific research, DATATRAK will enhance your information needs with our sophisticated enterprise workflow.  Learn More About Medical Imaging Capture >> Built for Enhanced Monitoring The partial metadata functionality gives you the flexibility to be more productive in your data cleaning, which includes risk-based monitoring. Take clinical and operational data directly from the DATATRAK platform, while ensuring ICH E6 (R2) Compliance. Maximize the Benefits of your risk-based monitoring strategy by utilizing out-of-the-box functionality for SDV, Data Review and eSigniture. DATATRAK ONE can generate KRI’s, KPI’s, and sponsor defined metrics for every step of clinical trial workflow, customized to align with your processes. This functionality allows the creation, implementation, and monitoring of both static and dynamic plans in real-time. These metrics are supported with dashboards that provide study health, recruitment, monitoring, data cleanliness status and reports. Learn more About Risk-Based Monitoring >> Learn More About Risk-Based Monitoring >> lorem ipsum Managed Individual Case Safety Reports  Adverse events and Serious Adverse Events are easily managed from within our EDC platform, while Cross Study Managers can filter across entire drug programs to see information in one location. When an event is marked as “serious,” system generated email notifications can be sent to alert specified users. Specific questions and reports can be added to the study to collect specifics of the event data, and PDF’s can be created for narratives. If the eCRF is updated, another system generated alert can be sent to notify your safety team. To reduce duplicate or redundant data entry, SAEs can be linked to ConMeds, and data from the EDC can be mapped to a CIOMS or MedWatch form. If using a PV system, an E2B XML export can be generated for use with your Parmacovigilance system. Simple and Powerful RTSM Our Randomization and Trial Supply Management supports all types of protocol requirements while dispensing, controlling and automating drug supply fulfillment, while controlling visibility of your events with blinded and unblinded roles.  Learn More About RTSM >> Streamlined Trial Design DATATRAK Trial Design streamlines the entire design-to-deployment process using a single tool, utilizing either a drag-and -drop visual designer, or excel-based data architect intended for a power user.   Learn More About Trial Design >> Request a Product Demo > EDC Resources Leverage your EDC Solution to Mitigate Risk in Clinical Research Advances in technology provide tools to mitigate some of the risk introduced in our clinical trials. View Optimize your EDC for Risk Based Monitoring Learn how to optimize your investment in EDC when implementing Risk Based Monitoring. View See How to Streamline Mid-Study Changes with Technology Change Management, Deployment Challenges & Multi-System impact simplified with EDC. View The Next Step If you’re ready for more information, a DATATRAK expert is ready to help you get started. Message us here, and we will contact you shortly to help make the process as smooth as possible. Contact Us

Simple and Powerful RTSM

Our Randomization and Trial Supply Management supports all types of protocol requirements while dispensing, controlling and automating drug supply fulfillment, while controlling visibility of your events with blinded and unblinded roles. 

Streamlined Trial Design

DATATRAK Trial Design streamlines the entire design-to-deployment process using a single tool, utilizing either a drag-and -drop visual designer, or excel-based data architect intended for a power user.  

EDC Resources

Leverage your EDC Solution to Mitigate Risk in Clinical Research

Advances in technology provide tools to mitigate some of the risk introduced in our clinical trials.

Optimize your EDC for Risk Based Monitoring

Learn how to optimize your investment in EDC when implementing Risk Based Monitoring.

See How to Streamline Mid-Study Changes with Technology

Change Management, Deployment Challenges & Multi-System impact simplified with EDC.

The Next Step

If you’re ready for more information, a DATATRAK expert is ready to help you get started.
Message us here, and we will contact you shortly to help make the process as smooth as possible.