TrialAmicus V-Reg

Regulatory Distribution & Execution Platform

TrialAmicus V-Reg is a sponsor-controlled regulatory distribution and execution platform, delivered through a paper-like site tablet.

Compliance Monitoring Real-Time Regulatory Updates Cited, Traceable Responses
Status
Coming Soon

TrialAmicus V-Reg is currently in development. Be among the first to access the regulatory platform that keeps your team aligned and submission-ready across every phase of clinical research.

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ABC Therapeutics / CRO Name
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09:22
TrialAmicus
V-Reg
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ABC-123 Protocol V4
ABC-123 IB v5. 26 Sep...
JKL-555 Pharmacy m...
XYZ-255 Lab manual
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ABC-123›Protocol & amendments
Protocol & amendments
Section 5 · 3 documents · Last updated 14 Mar 2026
Investigational protocol v3.1
Amendment 2 · Distributed 14 Mar 2026 · Current
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All versions
Investigational protocol v3.1
Amendment 2 · Distributed 14 Mar 2026
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›
Investigational protocol v2.4
Amendment 1 · Signed 02 Jan 2026
Signed
›
Superseded versions — retained for inspection
Investigational protocol v1.0
Original · Signed 15 Dec 2025 · Superseded 02 Jan 2026
Superseded
›
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ABC-123
Protocol: XXY-XX · v3.1 active
Table of contents
1.
Correspondence / contact list
2.
Subject enrolment
3.
Site monitoring, visit forms
4.
Serious adverse events / safety
5.
Protocol and protocol amendments
Sign
6.
Investigator's brochure (IB)
7.
Investigator agreements
8.
Delegation of authority
9.
CVs / credentials
10.
Site training documentation
11.
IRB submissions
New
12.
Informed consent form
13.
Vendor manuals
14.
Site operations manual
TrialAmicus V-Reg
TrialAmicus V-Reg
Regulatory document platform · 21 CFR Part 11 compliant