eRegulatory binder (eISF)

What does eRegulatory binder (eISF) mean in clinical research?

The investigator site file is the set of essential records a site keeps for each study: approvals, delegation and training logs, protocol versions, consent form versions and correspondence. An electronic investigator site file (eISF), also called an eRegulatory or eReg binder, keeps those records digitally. Florence Healthcare describes its eISF as allowing remote monitoring, document sharing, study management and compliance supervision in one place.^⁠[1]

Recruitment creates regulatory records too. ICH E6(R3) lists records that document the recruitment, pre-trial screening and consenting process of trial participants among a trial's essential records.^⁠[2] IRB-approved call scripts, text messages, advertisements and any AI disclosure language belong in the binder with their approval dates, next to the screening log.

Practical note: eISF platforms are now common; Florence says its eISF is trusted by more than 65,000 sites.^⁠[3] If a recruitment vendor produces logs or approved materials, agree up front how they will get into the site's eISF. Bond works alongside eRegulatory platforms such as Veeva SiteVault through export or API where the vendor supports it; see Implementation.

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each patient's randomization milestone payment.^⁠[4],[5]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[4]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[5]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[4],[5]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[4],[5]
• No integration fee, and a price that moves with randomization. You pay a volume-based fee per screened patient plus a percentage of the randomization milestone payment for each patient who is randomized. See pricing.^⁠[5]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.