Innovedge Consultants, LLC

Supporting sponsors, clinical research organizations, investigator sites, and vendors, with compliance-driven quality assurance solutions.

About us

Who We Are

Your Partner in Clinical Quality & Compliance

We are a specialized Clinical Quality Assurance consulting group dedicated to ensuring excellence, compliance, and inspection readiness across clinical research and healthcare operations. Our team brings deep expertise in global regulations, quality systems, and risk-based auditing to help organizations meet regulatory expectations with confidence.

Clinical Quality Assurance Consulting

Quality Management System (QMS) development and optimization

SOP creation, review, and remediation

Risk-based quality strategies

Inspection Support

Inspection readiness for sponsor, sites, and vendors

Storyboarding

Hosting, back room, front room support

Audits

Internal and external clinical audits

Vendor and CRO audits

Investigator site audits

Regulatory Compliance Support

ICH-GCP, FDA, EMA, and global regulatory alignment

CAPA development and oversight

Compliance gap assessments

Training & Education

GCP and quality training programs

Customized workshops for clinical teams

Ongoing compliance education

Industries We Support

Pharmaceutical & Biotechnology Companies

Clinical Research Organizations (CROs)

Medical Device Companies

Academic Research Institutions

Healthcare & Life Sciences Organizations

Our Approach

Quality Built Into Every Step

We partner closely with your team to understand your processes, identify risks, and implement sustainable quality solutions. Our approach emphasizes proactive compliance, continuous improvement, and long-term operational success.