Expertise.
Clinical Compliance.
Ensure that your clinical trials comply with regulatory requirements and meet the highest quality standards.
Compliant?
Do your clinical trials meet the regulatory requirements and official regulations?
Secure?
Do you ensure that your study processes meet the highest quality standards?
Sustainable?
Are your studies structured to ensure long-term compliance and success?
Ensure your clinical compliance.
Clinical compliance - ensuring regulatory conformity.
Our Clinical Compliance Service supports you in complying with all regulatory requirements and standards for clinical trials.
Ensuring compliance in clinical trials is crucial for successful completion and regulatory approval. Our clinical compliance experts will help you implement the necessary structures and processes to ensure that your clinical trials comply with the applicable regulations. From study planning to monitoring and documentation, we ensure that all regulatory requirements are met.
Our services include:
- Regulatory support: Advice and support in complying with national and international regulations.
- Quality assurance: Implementation and monitoring of quality systems to ensure study integrity.
- Compliance monitoring: Regular review of your study processes to ensure conformity with GCP (Good Clinical Practice)
Clinical Compliance Services at a glance.
Our Clinical Compliance Services cover all key areas of regulatory compliance and quality assurance.
Regulatory support.
- Advice on compliance with GCP and regulatory requirements
- Support with official applications and approvals
- Ensuring compliance during the entire duration of the study
Quality assurance.
- Implementation of quality assurance systems for clinical studies
- Continuous monitoring and improvement of study quality
- Preparations for official audits and inspections
Compliance monitoring.
- Conducting internal audits and reviewing study processes
- Ensuring compliance with GCP standards and regulatory requirements
- Follow-up and monitoring of study deviations
Successful clinical compliance projects in the life science industry.
Our clinical compliance projects help companies to conduct their clinical trials efficiently and in compliance with regulations.
Ensuring GCP compliance for a pharmaceutical company
Audit preparation for a clinical study of a biotechnology company
Optimization of compliance processes in a clinical study for a medical technology company
Challenge.
A pharmaceutical company needed support in ensuring GCP compliance in a multinational clinical trial.Measures.
- Implementation of a quality assurance system in accordance with GCP standards
- Training the team to ensure compliance with regulatory requirements
- Regular review of study processes through internal audits
Results.
- Full GCP compliance throughout the study
- Improved quality of study data and reporting
- Successful official inspection without objections
Success.
The company was able to conduct its clinical trial successfully and in accordance with the regulations and complete the approval process on time.Ensure your clinical compliance and study quality.
Our Clinical Compliance Service Portfolio.
Our clinical compliance portfolio supports you in ensuring regulatory compliance and quality assurance in clinical trials. We offer comprehensive solutions to make your study processes efficient, compliant and sustainable.
We advise you on compliance with international regulations and GCP (Good Clinical Practice) standards. Our experts will accompany you throughout the entire duration of the study, including support with regulatory applications and approvals. You can find more information on GCP standards in the ICH GCP guidelines and from the EMA.
Our quality assurance systems ensure the integrity of your clinical trials and the security of your data. We implement quality assurance measures, monitor their implementation and prepare you optimally for regulatory audits. Visit our Quality Management page for more details
We conduct regular audits and reviews of your clinical trials to ensure that all processes comply with the applicable standards. Our experts help you to follow up on study deviations and optimize processes. Find out more in the FDA Clinical Trials Guidance.
Ensure the regulatory compliance of your clinical trials.
Clinical Compliance - Related topics for clinical compliance and safety.
These complementary services ensure that your clinical processes meet the highest regulatory requirements:
