At PHARMALANE UK, our highly experienced, trained, and competent GCP auditors conduct comprehensive GCP auditing services across various therapeutic areas, complying with international and national regulations as per the clients’ need.
Conducting GCP audits can be complex due to the nature of clinical trials and the diverse locations of investigator sites however our expert team (based locally as well as globally) is proficient in managing the cultural diversity encountered and ensuring thorough and effective audits. Our audits encompass various aspects, including Site Monitoring, Trial Management, and the activities conducted by monitors. Audit reports prepared followed by the audits are the honest representation of whatever has been cited and comprehensive enough for the clients to have an overview of audited company.
With a global reach and a focus on key regions such as the EU, UK, USA, Asia etc., PHARMALANE UK is dedicated to providing top-notch GCP auditing services, meeting the highest standards of quality and compliance.
FULL CLINICAL TRIAL AUDITS: In-depth assessment of clinical trial sites to ensure compliance with GCP guidelines and regulatory standards.
CRO AUDITS: Comprehensive assessments of Contract Research Organizations (CROs) managing trials on behalf of sponsors to ensure they adhere to all necessary regulations and standards.
CRO QUALIFICATION AUDITS: Detailed audits to qualify and select the most suitable CROs for your clinical trials, ensuring they possess the necessary compliance and capabilities to conduct high-quality research.
SYSTEM AUDITS: Review of systems and processes used in clinical trials, such as electronic data capture (EDC) systems, quality management systems (QMS), and trial master file (TMF) system, Verification of system validation, data security, and compliance with regulatory requirements.
INVESTIGATOR SITE AUDITS: Evaluation of the compliance of investigator sites with GCP guidelines, protocols, and regulatory requirements. Review of site facilities, documentation, informed consent process, and data integrity.
MOCK INSPECTIONS: Preparation and Training for upcoming inspections. Practice inspections to simulate real scenarios, ensuring that teams are well-prepared. Assistance and Coordination during actual inspections to facilitate a smooth process.
DOCUMENT AUDITS: Detailed review of various critical documents to ensure compliance. This includes checking protocols, case report forms, informed consent forms, investigator handbooks, clinical study reports, and safety update reports throughout the development process.
VENDOR AUDITS: Inspection of third-party vendors providing services such as data management, laboratory analysis, or equipment which provide the assurance that vendors adhere to GCP and relevant regulatory standards.
QUALITY ASSURANCE (QA) AUDITS: Comprehensive assessment of the overall quality assurance framework within an organization. Evaluation of QA processes, SOPs, and adherence to quality standards.
FOR-CAUSE AUDITS: Targeted audits initiated in response to specific concerns or issues identified during a clinical trial are conducted by the experts to ensure issues are identified and rectified. Focused investigation to address and resolve identified problems.
ROUTINE AUDITS: Regularly scheduled audits to ensure ongoing compliance with GCP and regulatory requirements. Continuous monitoring and improvement of clinical trial processes and practices.
CONSULTANCY SERVICES: Expert support in developing Standard Operating Procedures (SOPs) tailored to the specific needs, Thorough evaluations of Quality Management System (QMS) to identify areas for improvement and ensure adherence to industry standards. Keeping informed about the latest developments and changes in regulations.
SO, what are you waiting for, please contact us now for any of the related support you may need and we are happy to help!
Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier: