Capque Technologies launches Part 11 electronic signature tool for clinical trials

Capque Technologies has launched CapqueSign, a new electronic signature platform for regulated clinical research, with self-serve pricing and built-in 21 CFR Part 11 controls. The Atlanta-based launch targets sponsors, CROs and site networks that need compliant signatures without enterprise procurement delays.

Why it matters: - CapqueSign aims to make 21 CFR Part 11-compliant electronic signatures easier to adopt for smaller sponsors, CROs and site networks. - The platform bundles core compliance controls into every plan, including multi-factor authentication and full audit trails. - The launch could reduce time and cost for clinical teams that need regulated signing workflows for trial documents.

What happened: - Capque Technologies LLC launched CapqueSign on October 20, 2026. - CapqueSign is an electronic signature platform for clinical trial documents. - ClinFocus Inc., an Atlanta-based clinical research organization, powers the platform. - CapqueSign is the first product on the Capque Connected Intelligence platform. - The platform supports protocols, protocol amendments, site agreements and other trial documents in PDF and Word formats.

The details: - Electronic signatures used in FDA-regulated clinical research must meet 21 CFR Part 11 requirements for signer authentication, signature manifestation, record linkage and secure audit trails. - CapqueSign includes the same core controls on every plan. - Each signer confirms identity with multi-factor authentication before signing. - Every action is recorded in a full audit trail. - Users can export the audit trail in one step for quality review or filing in an electronic trial master file. - Senders can set signing order and deadlines. - Automated email notifications and reminders keep documents moving without manual follow-up. - The Free plan allows three envelopes per month and does not require a credit card. - 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 includes 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. - Standard and Enterprise customers can request the validation package for internal quality assurance review. - Each regulated organization remains responsible for confirming the system fits its intended use under its own procedures and training. - CapqueSign is available now with self-serve registration at CapqueSign. - Enterprise inquiries can be submitted through the contact page on the same site. - Capque Technologies also directs readers to more information about the company. - ClinFocus provides clinical data management, biostatistics, clinical programming and systems integration services. - ClinFocus is a Medidata Rave accredited partner and operates under 21 CFR Part 11, ICH E6(R3) and GxP frameworks. - ClinFocus also operates a Nigeria-based subsidiary, CFGSN.

Between the lines: - The pricing structure suggests Capque Technologies is targeting teams that need regulated e-signatures but cannot justify enterprise software contracts. - Offering validation evidence on request may help quality teams review compliance without waiting on a custom sales process. - Making MFA and audit trails standard across all plans positions compliance features as baseline infrastructure rather than add-ons.

What's next: - Capque Technologies says clinical teams can start on the free plan and move to Standard without a procurement cycle. - Enterprise customers can pursue custom pricing through direct inquiry. - The company is likely to use CapqueSign as the entry point for the broader Capque Connected Intelligence platform.

The bottom line: - CapqueSign enters the market as a low-friction, Part 11-focused signature tool for regulated clinical research, with transparent pricing and compliance controls built in from the start.