Bringing Clarity to Complex Clinical Environments
We partner with Sponsors and CROs to strengthen inspection readiness, improve operational quality, and optimize Trial Master File (TMF) health through practical, experienced support.
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Focused on Your SuccessA Boutique Firm Built on Proven Experience
After years of supporting life science organizations around the world, CRG Advisors was launched to provide Sponsors and CROs with the experienced, hands-on advisory support they need—practical, responsive, and detail-oriented.
We work as an extension of your team, bringing clarity to complex clinical environments where scrutiny is high and details matter.
What We Do
Quality Assurance & Systems
Strengthening quality systems, compliance programs, and operational processes to reduce risk, improve oversight, and support inspection readiness.
Regulatory Support & Compliance
Providing strategic regulatory guidance and submission support to help organizations navigate complex requirements and maintain compliance throughout the clinical trial lifecycle.
TMF Management & Oversight
Delivering expert TMF services and solutions that ensure complete, inspection-ready documentation while improving efficiency, oversight, and compliance.
About Our Founder
Sholeh Ehdaivand is a TMF subject matter expert with more than 20 years of experience in the clinical research industry. Her background spans all therapeutic areas, with extensive expertise in study management and the operational execution of clinical trials.
Her areas of specialization include the CDISC TMF Reference Model, eTMF management, regulatory submissions, quality control processes, clinical trial operations, vendor management, and global inspection readiness.
Drawing on hands-on experience across domestic and international pharmaceutical and biologics clinical trials, she brings deep industry knowledge and a commitment to helping organizations strengthen compliance, optimize operations, and achieve sustainable growth.
Let's Discuss Your Needs
Tell us about your challenges and goals. We'll work with you to build practical, effective solutions that support clinical trial success.