RegAlign provides regulatory and quality support that strengthens clinical research performance across sites, CROs, and sponsor programs — built around four areas: data review, audits and inspection readiness, SOP development, and compliance training.
Every engagement is scoped to your organization's actual needs. The result is durable: processes that hold up under scrutiny and an organization that stays inspection-ready between audits.
Our Services
Audit & Inspection Readiness
Data Review Solutions
Find out what's missing before an inspector does.
A clear picture of where you stand — before anyone official asks.
A verifiable foundation for every member of your research team.
Browse our core SOPs. Built to standard. Tailored to your site.
Training & Certifications
SOP Development
Our Packages
RegAlign's service packages are structured around how clinical research organizations actually need support — not one-size-fits-all retainers. Whether you need ongoing quality oversight or targeted help for a specific study or gap, we scope engagements to your situation and build from there.
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RegAlign conducts scheduled audits to maintain ongoing data quality, ensure regulatory compliance, and identify potential issues before they escalate into audit findings.
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We deliver annual regulatory compliance training to keep site staff current with evolving FDA, GCP, and ICH guidelines, reinforcing inspection readiness and embedding quality practices into daily operations.
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We support targeted, a la carte initiatives—including focused data reviews, SOP development, or inspection preparation—providing flexible solutions to address immediate compliance needs or project-specific objectives.
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Independent quality assessments for studies or sites facing regulatory, operational, or data integrity concerns. This audit service conducts structured reviews of trial conduct, regulatory files, essential documentation, and operational processes to identify compliance gaps and potential inspection risks. Findings are paired with corrective action guidance to quickly restore quality standards and ensure alignment with GCP and sponsor expectations.
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Comprehensive support to accelerate trial activation and ensure regulatory readiness. This service manages core start-up activities including site feasibility coordination, regulatory document preparation and submission, IRB/EC communication, essential document management, and site activation workflows. The objective is to reduce start-up timelines, eliminate administrative bottlenecks, and ensure sites are operational and compliant from day one.
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Targeted clinical monitoring designed for studies experiencing operational risk, enrollment delays, or compliance concerns. This service provides focused oversight of site performance, source data verification, protocol adherence, and regulatory documentation to rapidly identify and correct issues. The goal is to stabilize study execution, restore sponsor confidence, and maintain data integrity during critical trial phases.
If you're interested in working with us, complete the form with a few details about your project. We'll review your message and get back to you within 48 hours.