Good Clinical Practice
Accelerating clinical success through innovation and integrity
Good Clinical Practice
Accelerating clinical success through innovation and integrity
Protecting patient safety and data integrity
Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard that ensures the rights, safety, and wellbeing of participants in clinical trials are protected, and that the data collected is reliable.
G&L helps organizations uphold these standards by providing expert services that ensure compliance with GCP requirements.
Our services include auditing Trial Master File (TMF), Sponsor and Clinical Investigator sites as well as clinical vendors to ensure both ethical conduct and the generation of trustworthy, high-quality data in the clinical trials.
Expert-led GCP compliance at every step
G&L assists organizations in navigating Sponsor oversight requirements, ensuring their clinical trials meet required GCP standards.
Our tailored GCP support services assure stakeholders, including Sponsors, regulatory agencies, trial participants and patients that a trial is conducted responsibly and that the sponsor is dedicated to maintaining high quality and standards.
Services include:
- Audits of Trial Master Files (TMF)
- Good Clinical Practice (GCP) inspection readiness
- GCP auditor
- Quality Management System (QMS) development
- Remediation/troubleshooting
- Sponsor/study site and/or system Gap assessment
- Hosting of and/or assistance with Regulatory Authority inspections
- Assistance/guidance for studies on clinical hold or sites with compliance issues
- For cause audits
- Assessment, development and implementation of GCP Quality system
- On-site and/or remote Quality support
- Site and Project Management services
- GCP training
- Document control and lifecycle management
Phase-appropriate and fit-for-purpose QMS
G&L works with you to design and implement Quality Management Systems (QMS) that are tailored to the specific needs of your product’s development stage.
Whether you are in early clinical trials or scaling up for commercial production, our QMS solutions ensure that you meet all relevant GxP requirements while maintaining operational efficiency.
Fractional Head of Quality
For companies that require senior Quality leadership but may not need a full-time executive, G&L offers Fractional Head of Quality services.
Our experienced consultants step in to provide strategic direction, oversee quality operations, and ensure that your quality systems are robust and compliant.
Remediation and troubleshooting
When challenges arise, G&L is there to help.
Our remediation and troubleshooting services are designed to identify and address quality issues quickly and effectively, minimizing disruption and ensuring that your products and processes remain compliant.
Whether you’re facing issues with audits, inspections, or routine operations, our experts provide the guidance and support needed to get back on track.
Inspection readiness
Preparing for regulatory inspections is critical to maintaining compliance and avoiding costly delays.
G&L’s inspection readiness services help you anticipate and address potential issues before they arise.
We work with your team to conduct mock inspections, review documentation and ensure that your facilities, processes, and staff are fully prepared to meet regulatory expectations.
Case study
Clinical Quality Assurance support for novel therapeutic agent
"G&L conducted a meticulous review of the client's TMF over five days"
