For over two decades, clinical researchers have entered trial data into their institution’s healthcare system (Electronic Health Record - EHR) only to then transcribe that same data into the sponsor's research database (Electronic Data Capture - EDC). There was no way to bridge these two incompatible eco-systems. Clinical Pipe seamlessly transfers data between any EHR and industry-sponsored EDC system.
The application offers a comprehensive, scalable and mostly automated configuration and validation process. The days of one-off pilot or custom developments are over!
It’s an EHR-to-EDC connector that uses the latest SMART on FHIR standards to transfer data from one system to the other. The app seamlessly connects to leading EHR and EDC systems. The current manual transcription process is expensive, time intensive and error prone (up to 9% according to a recent Duke study).
Depending on the therapeutic area, 30-70% of data can be pushed from one system to the other. This is the first scalable integration of EHR and EDC. It represents a huge leap towards unlocking the power and value of technology within the life sciences industry.
Clinical Pipe is light-weight by design. It connects disparate systems with a deceivingly simple interface. The research coordinator launches the app from within their EHR, similar to a web browser extension. Clinical Pipe’s proprietary mapping algorithm then uniquely matches structured fields within the EHR with their counterpart in the EDC, allowing data to be pushed from one system to the other, with a click of the mouse.
The research coordinator maintains complete control over the data throughout, so the process is GCP-compliant. The application is also fully validated and study-by-study verification is nearly fully automated. After initial install at the institution, any new or existing trial can utilize the connector and reap the benefits.
In addition to structured data, Clinical Pipe also pulls unstructured data from progress notes and various reports. The app then processes those reports and notes via any leading NLP (Natural Language Processing) engine and presents the PI/research coordinator with interpreted data or events that can then be submitted to the industry sponsor.
This is revolutionary for early safety system detection or identification of particular stages/ratings of disease progression.
We are handling patient health information and populating clinical research databases. Security and compliance are therefore of paramount importance. We provide a rich set of security, process and administrative controls to meet and exceed requirements and standards for healthcare and clinical research. Including, but not limited to - HIPAA Security Rule, NIST CSF, 21 CFR Part 11, and ICH/GCP regulations.