GOOD CLINICAL PRACTICE (GCP)

Our team of specialist GCP auditors is unparalleled in expertise and training, having successfully completed a multitude of audits across many therapeutic domains. We take pride in our global presence, with a track record that spans over a wide range of countries, underpinned by adherence to both international and national standards.

Navigating the intricacies of GCP quality audits in today’s world presents a unique set of challenges, given the intricate nature of clinical trials and the widespread distribution of investigator sites. While sponsor organisations are predominantly based in Europe, the USA and Japan, their research reaches across the globe, extending to Asia, Africa, South America, the Middle East, and the Far East.

Our auditors transcend the mere logistical hurdles of reaching these remote locations; they excel in bridging the gap between diverse cultures with sensitivity and finesse. With SPGL’s personnel positioned worldwide, we are strategically placed to overcome language barriers, minimise travel time and expenses and facilitate seamless audits.

Our range of GCP services encompass:

Investigator Site Audits

  • Routine Investigator Site Audits (Phase I to IV)
  • Targeted Investigator Site Audits (Phase I to IV)
  • For cause Investigator Site Audits (Phase I to IV)

System Audits

  • System audits of sponsor/CRO/Phase I

Mock inspection

  • Inspection preparation and training (investigator site/CRO/sponsor)
  • Mock inspections
  • Inspection facilitation

Vendor system audits

  • Interactive Response Technology (IRT)
  • Central ECG reading SP
  • Call centres
  • Data Management
  • Database
  • Biostatistics
  • Regulatory
  • Trial Master File (TMF)
  • Clinical Trial Supply (CTS) compliance with Good Distribution Practice (GDP)
  • Translation Services
  • Clinical Manufacturing Organization (CMO) compliance with Good Manufacturing Practice
    for Investigational Medicinal Product (GMP for IMP)
  • Archives

Document Audits

  • Study Protocols
  • Case Report Forms (CRFs)
  • Informed Consent Forms (ICFs)/Patient Information Sheets (PISs)
  • Investigator Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • Summary of Clinical Efficacy (SCE)
  • Summary of Clinical Safety (SCS)

Quality Management System (QMS)

  • Review of existing QMS
  • Gap analysis
  • Developing a new QMS (writing company policies, standard operating procedures, work
    instructions, etc.)
  • Corrective and Preventative Action Plan (CAPA)/Effectiveness Check (EC) review
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