Ever since healthcare data was first stored in electronic format, sponsors have wanted a straightforward and complete method of acquisition. With the advent of the Internet, EDC came about to web-enable the data entry process. Unfortunately, while EDC has undeniable benefits (e.g. enabling global clinical trials or accelerating database lock), it also shifted the burden of data entry to research sites.
Bypassing the traditional paper-based data entry at centralized data management locations, EDC redefined “double data entry” to mean: enter it once in the EHR and then transcribe it into the EDC. In truth, the process is much more complex. First, the EHR data needs to be located, then printed and then organized for data transcription… with delays and risks at every step of this tedious process.
Using Clinical Pipe, your sites can now transfer patient data directly from their EHR into your EDC - at the click of a button. This means you get higher quality/cleaner data because there’s no transcription error risk. Your sites will thank you too - their double data entry will drastically decrease and you will get your data faster. Clinical Pipe allows PIs and research staff to spend more time executing your protocol, taking care of their patients; all while spending less time in front of their computer.
Clinical Pipe not only provides the cleanest, fastest way to collect patient data for clinical research, it also gives you a level of data validation you simply can't find elsewhere.
With 100% consistent data from source, you can adjust your risk-based monitoring, edit checks, and other strategies used to get to clean data. You can now focus your data analytics on higher value-added tasks such as data-driven review and early safety detection.
Clinical Pipe or the Sponsor/CRO can rapidly configure each version of the EDC trial and then automatically generates the validation artifacts needed by data management.
- Mapping takes a few hours and we can map your global eCRF libraries ahead of time, to accelerate matters further.
- For protocol amendments, new mapping is typically expressed in hours, if not minutes.
- All validation artifacts are system-generated within minutes.
Study-level validation is completely separate from our one-time validation of a given health system’s EHR system validation. New studies, at already connected sites, do not require any additional site validation.
Clinical Pipe not only replaces manual data transcription with one-click data transfers, it also allows the insertion of data into the EDC with sponsor-defined flags such as “frozen” or “verified”. Back-end operations are significantly improved, markedly reducing the need for Source Data Verification (SDV), and allowing your DM/clinical monitoring teams to focus on higher value-added monitoring and data-driven reviews.
Hybrid rollouts of Clinical Pipe are very common, where some sites use Clinical Pipe and others do not. You can still build your EDC studies the way you always have, the application does not affect EDC edit checks or queries. We will work with your DM team to optimize some of your CRFs and logs to best leverage automated data acquisition.
Our end-to-end solution allows Clinical Pipe to rapidly configure each version of the EDC trial and then automatically generate the validation artifacts needed by data management. The process is identical for any version of the database - whether new or an amendment.
Clinical Pipe only replaces manual data entry with automated transfers. All your other data cleaning tools remain in place - edit checks, auto and manual queries all work within your EDC or data lake solution.
For example, Rave - when saving data through Rave Web Services (RWS), Rave will run the edit checks as if the user clicked on the save button within the EDC environment.
Clinical trials are growing in complexity and current monitoring activities are highly resource intensive. With Clinical Pipe, we allow you to drastically reduce SDV and focus your clinical monitoring activities on much more sophisticated audit and safety/clinical review functions.
When needed, monitors/CRAs can work with the clinical research coordinator to quickly resolve lingering issues via EDC-based queries. With far fewer queries, you will finally catch the attention of your PIs and research coordinators.
All of the audit trail information will exist in the EDC, including reason for change. The only difference with manual data entry is that data inserted via Clinical Pipe will be noted accordingly in the EDC audit trail.
Changing something, anything, can be hard. Modifying nearly two decades of established EDC processes, in a heavily regulated environment, is definitely not easy. To help you navigate this new paradigm of data acquisition, we recommend a crawl-walk-run model.
Crawl is a proof-of-concept, using a test EDC database. We map it and connect it to mock EHR data. This allows you to gain familiarity and a deeper understanding of how Clinical Pipe works, before it touches any live data.
Walk is a pilot, using an existing or new study. We connect to your chosen institution, using real patients and data. This process allows you to gather operational metrics that you can show to key stakeholders.
Run is the large-scale roll-out of Clinical Pipe, across a portfolio of studies, ongoing or new. We will help you get there by teaching you or your CRO to map and validate Clinical Pipe builds – a knowledge transfer.
Contact us today to become the “sponsor of choice” at your sites. They don’t want to transcribe data, they would rather be with their patients, and you want cleaner, faster, cheaper data. A true win-win-win for sites, patients and sponsor!