CapqueSign, Powered by ClinFocus, Launches Electronic Signatures for 21 CFR Part 11 Regulated Clinical Research

ATLANTA, GA, UNITED STATES, October 20, 2026 /EINPresswire.com/ — Capque Technologies LLC today announced the launch of CapqueSign, an electronic signature platform for clinical trial documents. CapqueSign is powered by ClinFocus Inc., an Atlanta-based clinical research organization specializing in clinical data management, biostatistics, clinical programming, and systems integration.

CapqueSign is the first product released on the Capque Connected Intelligence platform. It supports signing of protocols, protocol amendments, site agreements, and other trial documents in PDF and Word formats.

Electronic signatures used in FDA-regulated clinical research are subject to 21 CFR Part 11, which sets requirements for signer authentication, signature manifestation, the linking of signatures to records, and secure audit trails. Smaller sponsors, CROs, and site networks often find that signature tools charge extra for these controls or require lengthy IT and procurement cycles before use.

CapqueSign includes the same core controls on every plan. Each signer confirms identity with multi-factor authentication before signing, and every action is recorded in a full audit trail that can be exported in one step for quality review or filing in an electronic trial master file. Senders set signing order and deadlines, and automated email notifications and reminders keep documents moving without manual follow-up.

The Free plan allows three envelopes per month with no credit card required. The Standard plan costs $19.99 per user per month and includes 25 envelopes per user each month, priority support, and access to the CapqueSign validation package on request. The Enterprise plan offers unlimited users and envelopes with custom pricing based on users, volume, and sites. Annual billing includes two months at no charge.

Capque Technologies validated CapqueSign for 21 CFR Part 11 and provides its validation package to Standard and Enterprise customers on request, so customer quality assurance teams can review the evidence directly. Each regulated organization remains responsible for confirming the system fits its intended use, consistent with its own procedures and training.

“Small sponsors and CROs run the same regulated processes as large pharmaceutical companies, but enterprise signature contracts often price them out or charge extra for the controls Part 11 requires,” said Keke Okeke, Chief Financial Officer of Capque Technologies LLC. “We priced CapqueSign so a clinical team can start on the free plan and move to Standard at $19.99 per user per month without a procurement cycle. Audit trail and MFA come with every plan, because compliance controls should not be a premium feature.”

CapqueSign is available now with self-serve registration at https://capquesign.com. Enterprise inquiries can be submitted through the contact page on the same site.

About Capque Technologies LLC
Capque Technologies LLC develops the Capque Connected Intelligence platform, software built for compliance-driven clinical research. CapqueSign, the platform’s first release, is powered by ClinFocus. Learn more at https://capque.com.

About ClinFocus Inc.
ClinFocus Inc. is an Atlanta-based clinical research organization providing clinical data management, biostatistics, clinical programming, and systems integration services to life sciences sponsors. ClinFocus is a Medidata Rave accredited partner and operates under 21 CFR Part 11, ICH E6(R3), and GxP frameworks. The company also operates a Nigeria-based subsidiary, CFGSN. Learn more at https://clinfocus.com.

Media Contact
Reece Collier
Business Development Director
ClinFocus Inc.
rcollier@clinfocus.com
https://clinfocus.com

Reece Colier
ClinFocus Inc
+1 404-737-8352

Legal Disclaimer:

EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Media gallery