Case Study

eRegulatory: A Site's Perspective

Source: Complion
Doctor ON tablet

Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. However, the research staff questioned if it was just a “shiny” IT system they could show to their sponsors to appear progressive or would it indeed be something that proved to be extremely beneficial to them as a site.

To prove an eRegulatory system had value, the site gathered feedback from sponsors with whom they had long-standing relationships, and with the CROs and CRAs they had used for multiple studies. They let the group know what CPR was trying to accomplish by using an eRegulatory system and then asked their opinion on if such a system was adopted: How would sponsors take it as a CRO or CRA? Would they be open to using an eRegulatory system at their site? Would it make site visits more productive in terms of previewing the patient data versus the regulatory piece and would it make it any easier for them as well?

The team received overwhelming positive feedback. All parties were on board and indicated they’d be very supportive of Coastal adopting an eRegulatory system. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

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