New and improved clinical research systems such as site-based eSOURCE and eRegulatory systems, in addition to enhanced CTMS are the backbones of the Pacific Clinical Research Network’s (PCRN) reputation for top performance, industry-leading data quality, and audit-ready compliance. Some of the benefits of these advanced paperless systems were only realized after full implementation into all PCRN sites.
It was only a few years ago that site-focused paperless systems started to become more widely adopted by sites around the globe and even more recent that Sponsors and CROs have come to understand their full benefits. PCRN was an early adopter of these systems due to the fact that they are designed to promote higher quality and oversight as well as efficiency and compliance. These are powerful combinations that help PCRN uphold its core values and organizational mission.
So how do these systems promote all of the above? Here are just a few examples:
- Site-centric eSOURCE allows PCRN to create and standardize data collection tools that drive visit workflows that conform to SOPs and ensure data meets stringent ALCOA standards.
- eSOURCE also allows for electronic site staff communication, follow-up tasks, complete audit trails of data collection attributes, timely and documented investigator oversight, and so much more.
- eRegulatory systems ensure up-to-date and version-controlled staff and investigator records, complete and standardized study regulatory binders, efficient and timely filing of study records, staff and investigator signature routing and more.
- eDelegation logs provide for a completely paperless study Delegation of Authority Log that is electronically signed by all delegates and the principle investigator as required by regulations. Study Roles allow eSOURCE procedures and oversight taks to be limited to only “permitted” staff to further ensure compliance.
- Study monitors (CRAs) have complete remote access to all study data and eRegulatory files in real-time through an advanced monitoring portal. The monitoring portal allows for electronic queries to the site, query resolution tracking, monitoring progress tracking and more.
More advancements are coming to PCRN as eCONSENT and an advanced study participant portal are coming soon. These new systems will not only further improve compliance for PCRN sites but will also promote subject study compliance and retention by strengthening our connection with study volunteers. PCRN’s ability to support fully decentralized clinical trials will be in place by late 2021!
When selecting a site or site network to partner with for your next clinical trial, consider how invested they are in quality, compliance, efficiency, and execution. Access to real-time data and performance metrics will help to drive your overall study execution plan. If you would like to consider PCRN for your next trial, please contact us at info@pcrn.co.nz. PCRN is excited and ready to evaluate your study and provide excellent feasibility and performance strategies to exceed your expectations. Call us today!
