Sandy Pond GCP can help Sponsors with:

Clinical Document and Data Review (Protocols, pK reports, Clinical Study Reports)

Strategic Quality Assessment and Risk Analysis

Inspection readiness including  mock FDA inspections

Standard Operating Procedures

Site audits

Vendor audits

Internal Process Audits

Trial Master File Audits

Gap Assessment and remediation

Hosting GCP and PV/GVP Regulatory Inspections

Interim in-house GCP/QMS leadership

GXP Computer Systems implementation and audits

GXP Vendor Management

Development of Quality Oversight metrics

Sandy Pond GCP has experience in:

Oncology

Rare disease

Ophthalmology

Electrophysiology

Cardiology

Diabetes/Endocrinology

Medical Imaging

Neurology

 

Sandy Pond GCP, LLC brings over a decade of Clinical Research Quality and Compliance expertise to your company's GCP needs.