GCP, GLP & GCLP Compliance Consulting

PharMarketing provides GCP, GLP and GCLP compliance consulting for pharmaceutical, biotech, medical device, CRO and laboratory organisations. We help teams strengthen the processes, documentation, training and oversight needed to protect study participants, generate reliable data and prepare for audits and inspections.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials involving human participants. Good Laboratory Practice (GLP) establishes quality principles for the organisation, conduct, monitoring, recording, reporting and archiving of non-clinical safety studies.

GCP compliance for clinical research

Our GCP consulting services support sponsors, CROs, sites and clinical service providers throughout the clinical development lifecycle.

We can support:

GCP gap assessments and compliance roadmaps
Clinical operations and trial-management process reviews
Sponsor oversight and CRO governance
Clinical trial documentation and TMF process assessments
Monitoring, site-management and protocol-compliance reviews
Investigator-site and vendor audit support
Clinical data management process audits
Data integrity, traceability and record-retention assessments
GCP training for clinical teams and operational partners
GCP inspection readiness, mock inspections and CAPA support

GLP and GCLP quality support

PharMarketing helps laboratories and life sciences organisations assess and improve GLP and GCLP-related processes. Our work is adapted to the study type, laboratory role, systems, data flows and applicable requirements.

Our GLP and GCLP support can include:

GLP/GCLP gap assessments and audit preparation
Laboratory quality-system and SOP reviews
Study-plan, protocol, record and report reviews
Training and competency-management assessments
Sample, specimen and data traceability reviews
Equipment, calibration, maintenance and environmental-control oversight
Archiving, retention and retrieval process assessments
Laboratory information system and electronic-data governance reviews
Vendor, subcontractor and laboratory audit support

Clinical Data Management and Data Integrity

Clinical Data Management remains important but should be presented as a specialist GCP/GCLP capability rather than a disconnected service line. PharMarketing evaluates the processes and controls that protect the quality, completeness, consistency and traceability of clinical data.

Our assessments may cover:

Data-management plans, procedures and roles
EDC governance and user-access processes
Data cleaning, query management and reconciliation workflows
Database lock and data-transfer controls
Medical coding and safety-data interfaces
Audit trails, change control and data-integrity controls
Vendor oversight for outsourced data-management activities

Training and inspection readiness

We provide role-based GCP, GLP and GCLP training for clinical operations teams, laboratory personnel, project managers, quality teams and vendors. Training can be delivered remotely or on site and can be tailored to your study type, processes and audit findings.

For organizations preparing for an inspection, PharMarketing can conduct a focused readiness assessment, run mock interviews and help prioritise remediation activities before inspectors arrive.

PharMarketing combines knowledge of clinical research, laboratory operations, privacy, quality and computerised systems. This enables us to assess GxP compliance in the context of real operating models rather than a checklist detached from the people, suppliers and systems that create and manage your data.

Request a GxP Compliance Assessment