Expertise.
Good Clinical Practice (Clinical Trial).
Secure?
Compliant?
Ready?
Optimize your clinical trials now.
Good Clinical Practice - Compliance and quality assurance for clinical trials.
We offer you comprehensive support in complying with international regulations, including Regulation (EU) No. 536/2014. Through regular audits of your test sites and data, we ensure that you always comply with Good Clinical Practice requirements and pass inspections with ease.
Our services include:
- Regulatory compliance: Support in complying with Regulation (EU) No. 536/2014 and other international GCP regulations.
- Risk management in clinical trials: Implementation of GCP-compliant risk management strategies to identify and control potential risks.
- Quality assurance and data integrity: carrying out QA audits, SDV and SDR to ensure data integrity.
- Training and qualification of test sites: Training your trial sites and teams to comply with GCP standards.
GCP compliance services at a glance.
Regulatory compliance.
- Identification of compliance gaps and support in the creation of technical documentation.
- Preparation for GCP audits by global authorities, such as the EMA, to ensure compliance with regulatory requirements.
- Supporting compliance with international regulations, including Regulation (EU) No. 536/2014 and ICH GCP guidelines.
Risk management.
- Risk assessment and introduction of a comprehensive risk management system for clinical trials.
- Proactive risk minimization through regular evaluation and adjustment of risk strategies.
- Implementation of a GCP-compliant risk management system to ensure study quality.
Data integrity & quality assurance.
- Ensuring data integrity through SDV (Source Data Verification) and SDR (Source Data Review) processes.
- Implementation of QA audits to monitor and ensure GCP compliance.
- Introduction of digital solutions for real-time monitoring of clinical data.
Successful Good Clinical Practice compliance in clinical trials.
Our case studies show how Good Clinical Practice Consulting has helped companies to ensure compliance with GCP standards and successfully conduct clinical trials.
Challenge.
A global pharmaceutical company conducted clinical trials at several international locations. Compliance with GCP requirements and ensuring data quality were a challenge.
Measures.
- Harmonization of SOPs for all study locations.
- Introduction of a central monitoring system for the continuous review of GCP compliance.
- Training the international teams on GCP requirements.
Results.
- Improved consistency of study implementation.
- Faster regulatory approvals in various countries.
- Reduction of GCP violations by 25%.
Success.
Successful implementation of the international study in compliance with GCP requirements.
Challenge.
A biotechnology company had difficulties ensuring the integrity of study data in a decentralized clinical trial.
Measures.
- Introduction of a central data monitoring system to ensure data quality.
- Implementation of SDR and SDV processes to review the study data.
- Implementation of training courses to improve data management.
Results.
- 30% increase in data integrity through central monitoring.
- Reduction of deviations by 20%.
- Improved data quality in all study centers.
Success.
Successful assurance of data integrity and improvement of study quality.
Challenge.
A medical technology company needed to manage risks in a clinical trial while shortening the study time.
Measures.
- Implementation of a GCP-compliant risk management system.
- Introduction of BRAT (Benefit-Risk Action Team) for risk assessment.
- Adaptation of risk strategies to accelerate studies.
Results.
- Reduction of study risks by 40%.
- Acceleration of study time by 15%.
- Improving the traceability of risks.
Success.
Successful implementation of a comprehensive risk management system and acceleration of studies.
Optimize your clinical trials with GCP Consulting.
Our GCP Consulting Service Portfolio.
Our Good Clinical Practice Consulting Service portfolio offers comprehensive support to ensure GCP compliance and optimization of your clinical trials. We support you in complying with global regulations and standards and ensure the highest data integrity and study quality.
Ensuring compliance with international GCP standards, including Regulation (EU) No. 536/2014 and ICH GCP guidelines.
- EU Clinical Trials Regulation (EU) No. 536/2014: Support for the implementation of the regulation, which guarantees shorter approval times and the simplification of multinational clinical trials in the EU
- Global GCP standards: We ensure compliance with ICH GCP guidelines, which set globally harmonized standards for clinical trials to ensure consistent data quality and patient safety
Preparation for GCP audits by the EMA and inspection readiness according to international regulations.
- EMA GCP inspections: Helping to prepare for GCP inspections by the European Medicines Agency (EMA) and ensuring that all sites are brought up to date
- Inspection procedures: Implementation of a robust audit system for GCP compliance and preparation for regulatory inspections according to Regulation (EU) No. 536/2014
Ensuring the data integrity and quality assurance of your clinical trials through SDV and SDR.
- Source Data Verification (SDV) and Review (SDR): Conduct comprehensive data reviews to ensure that all clinical data is accurate and complete.
- Quality assurance audits: Implementation of QA audits to ensure compliance with GCP standards in all clinical processes and to identify and address potential risks at an early stage.
Introduction of GCP-compliant risk management strategies to proactively control potential risks in clinical trials.
- Risk management according to GCP: Identification and control of risks that may affect patient safety or data quality through the implementation of a comprehensive risk management system
- Proactive risk control: Regular evaluation and adjustment of risk strategies to minimize violations and ensure compliance with all regulatory requirements.