Our Services
RegAlign provides structured regulatory and quality support to strengthen clinical research performance and protect trial integrity across sites, CROs, and sponsor programs.
Our services include targeted data review and quality control processes to identify discrepancies early and reduce compliance risk, independent risk-based audits and inspection readiness assessments, SOP development aligned with ICH-GCP standards, and role-specific regulatory compliance training designed to embed quality into daily trial operations.
Each engagement is tailored to the complexity and oversight needs of the organizations we support, creating durable systems, consistent operations, and sustained inspection readiness.
Data Review
Third-Party Audits
RegAlign delivers structured, risk-focused data review designed to protect trial integrity and reinforce regulatory confidence. We conduct systematic evaluations of source documents, case report forms, and regulatory files to verify accuracy, completeness, and protocol alignment. By identifying discrepancies, documentation gaps, and emerging compliance trends early, we enable timely corrective action, strengthen data reliability, and reduce downstream audit exposure across the study lifecycle.
RegAlign provides independent, risk-based audits that evaluate compliance with GCP, protocol requirements, and regulatory standards. Our assessments simulate sponsor and regulatory inspections, uncover operational and documentation gaps, and deliver actionable recommendations to reinforce quality systems, improve process consistency, and ensure continuous audit readiness.
Regulatory Compliance Training
SOP Review & Development
RegAlign delivers role-specific regulatory compliance training that equips site staff to navigate FDA, GCP, and ICH requirements with confidence. Our tailored sessions—available in-person or virtually—emphasize practical application, protocol adherence, documentation standards, and inspection readiness, embedding quality practices into daily operations and strengthening overall audit preparedness.
RegAlign partners with clinical research teams to develop and optimize Standard Operating Procedures that are compliant, practical, and aligned with GCP and regulatory requirements. We tailor SOPs to each site’s workflows, ensuring consistency, accountability, and sustainable operational control, while reinforcing audit readiness and long-term quality infrastructure.
Our Packages
RegAlign offers flexible service options designed to meet the operational and compliance needs of clinical research organizations. Our ongoing support packages provide continuous, proactive quality oversight for sites seeking consistent regulatory alignment and inspection readiness.
Whether engaging as a long-term partner or for a discrete project, our packages strengthen compliance, streamline operations, and embed durable quality systems across every study and workflow.
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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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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.
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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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