About Q8 Consulting LLC
Pamela Shelton, Primary Consultant
As the primary consultant with over 20 years of clinical monitoring & quality assurance expertise, Pamela specializes in GCP audits for pharma, biotech, and CROs. With a rare combination of clinical monitoring precision, quality assurance depth, and emerging AI compliance fluency at the forefront of regulated life sciences, Pamela navigates FDA, ICH, EMA, and global regulatory frameworks with equal confidence across the industry, translating them into clear, actionable programs that organizations can realistically implement and sustain.
The focus is to turn complexity into clarity. Where others see a maze of overlapping regulations, inspection risks, and systemic gaps, Q8 Consulting LLC works to identify the path forward quickly and communicate it effectively to every stakeholder in the room, from research study coordinator to C-suite executive, with a meticulous, forensic attention to detail surfaces issues others often overlook.
Clients
Sponsors, CROs, investigator sites, and regulatory bodies have trusted Q8 Consulting, LLC as a strategic advisor across Phase I–IV trials in more than a dozen therapeutic areas, including hematology/oncology and rare disease.
Speciality
Expert GCP Auditing & Clinical Monitoring
Core GCP Audits:
- Investigator (routine, for-cause & inspection readiness)
- Trial Master File
- Clinical Study Report
- Site Management Organization
- Pharmacy
- Vendor (qualification & post capability)
- REMS (vendor, pharmacy & assessment report)
- SOP writing, GCP Training, CAPA support and CRA monitoring services also provided