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Services
Research Auditing and Quality Assurance
Our Research Auditing service provides a rigorous evaluation of your clinical studies to ensure full compliance with ICH GCP and regulatory standards. We audit site processes, documentation, and data, delivering detailed reports with actionable insights to prepare you for FDA, sponsor, or IRB audits. In addition, we offer ongoing quality assurance, helping sites establish and maintain effective CAPA plans, and supporting the creation of regulatory reports for IRBs, sponsors, and the FDA. As your partner in compliance, we strengthen the integrity of your research and set your site up for lasting success.
Regulatory Maintenance
Our Regulatory Maintenance service is tailored to ensure your clinical research stays compliant from start to finish. We specialize in managing and maintaining all regulatory documents and files, ensuring they are current and in full alignment with evolving standards. Additionally, we handle sponsor and CRO affairs, including coordinating meetings and overseeing monitoring visits, so you can focus on advancing your research while we manage the compliance and administrative details.
Clinical Research Consulting
Our Clinical Research Consulting service provides expert guidance to streamline your clinical trials and achieve optimal outcomes. We offer strategic advice on study design, regulatory compliance, and operational management. Our team supports research sites throughout the entire site start-up process, providing resources to effectively obtain studies. We also assist in achieving compliance with HIPAA, FDA, and OSHA regulations, ensuring that all aspects of your research operations meet the highest standards. With our comprehensive support, you can navigate challenges, enhance efficiency, and ensure a successful and compliant research journey.
CTMS Support
Our CTMS Services support sites in establishing compliant eSource and eISF systems tailored to their research needs. We assist with system setup and configuration, ensuring alignment with ALCOA+ principles, 21 CFR Part 11 compliance, and protocol-specific requirements. In addition, we provide staff training to promote proper use, efficient data entry, and ongoing regulatory compliance.
General Site Support
Our General Site Support services provide research sites with the tools and expertise needed to operate efficiently. We offer tailored staff training, staffing solutions, and data entry assistance to keep studies on track. Our team also supports sites with source document creation, SOP development, and ready-to-use regulatory templates, giving you a strong foundation for quality and growth.
Why connect with a research consultant?
In today’s competitive research environment, sponsors and CROs place high value on sites that demonstrate strong compliance, efficiency, and quality. Partnering with an experienced consultant not only elevates your site’s performance but also signals reliability to sponsors—giving you a clear competitive advantage when it comes to study selection.
Our team serves as both an expert resource and a lifeline, helping your site navigate regulatory demands, streamline operations, and build a reputation for excellence. With a consultant by your side, your site is better positioned for growth, long-term partnerships, and continued success in clinical research.
