Industries.
Clinical Monitoring.
Ensure compliance with GCP standards and data integrity in your clinical trials.
Compliant?
Are your clinical trials monitored and documented according to GCP standards?
Transparent?
Is your study data tracked efficiently and processed transparently?
Secure?
Are your clinical trial processes safe and error-free to meet regulatory requirements?
Ensure the quality of your clinical trials through efficient monitoring.
Clinical monitoring - quality assurance through comprehensive monitoring.
Our Clinical Monitoring Service offers you comprehensive support in monitoring your clinical trials to ensure GCP compliance and data integrity.
Compliance with Good Clinical Practice (GCP) and ensuring data integrity are critical to the success of your clinical trials. Our monitoring services offer you the opportunity to monitor all aspects of your clinical trial processes and ensure that the trials meet the highest regulatory requirements.
Our services include:
- Site monitoring: Regular monitoring of trial sites to ensure compliance with GCP standards and study protocols
- Data verification: Checking the study data for completeness, accuracy and consistency.
- Regulatory documentation: Ensuring the proper creation and maintenance of all regulatory documentation.
Clinical Monitoring Services at a glance.
Our Clinical Monitoring Services cover all aspects of clinical trial monitoring and ensure compliance with regulatory requirements.
Site Monitoring.
- Regular inspection of the test sites for GCP conformity
- Ensuring compliance with study protocols
- Monitoring of safety reports and study progress
Data verification.
- Checking data integrity and consistency
- Ensuring the correct recording of study data
- Implementation of Source Data Verification (SDV) and Source Data Review (SDR)
Regulatory documentation.
- Ensuring the correct creation and maintenance of the required documents
- Regular updating and archiving of study documents
- Preparation for official audits and inspections
Successful projects in the field of clinical monitoring.
Our clinical monitoring projects have helped companies improve the quality of their clinical trials and meet regulatory requirements.
Ensuring data integrity for a pharmaceutical company of CRO collaboration for a biotechnology company
Optimization of clinical monitoring for a biotechnology company
Implementation of a monitoring system for a medical technology company
Challenge.
A pharmaceutical company had to ensure that all study data was recorded consistently and in accordance with GCP.
Measures.
- Carrying out regular site monitoring visits to check data integrity
- Implementation of a system for continuous data verification
- Training the team on proper data collection and maintenance
Results.
- Improved data integrity and compliance with GCP guidelines
- Increased transparency and traceability of study data
- Successful preparation for upcoming official inspections
Success.
The company was able to ensure the data integrity of its clinical trials and meet the regulatory requirements on time.
Optimize your clinical monitoring and ensure your study quality.
Our Clinical Monitoring Service Portfolio.
Our Clinical Monitoring Service portfolio offers comprehensive solutions for monitoring clinical trials and ensuring data integrity and GCP compliance.
We regularly monitor your trial sites to ensure that all study protocols and GCP guidelines are adhered to. Our monitoring experts identify potential risks at an early stage and ensure that they are rectified in good time.
Our experts perform detailed Source Data Verification (SDV) and Source Data Review (SDR) to ensure that all study data is accurate and complete. This ensures the consistency and integrity of your data throughout the course of the study.
We ensure that all regulatory documents are properly created, maintained and archived. This includes preparing for regulatory audits and inspections as well as ensuring compliance with international standards such as GCP.
We implement Risk-Based Monitoring (RBM) to specifically monitor critical trial sites and trial data. Our RBM strategies focus on key indicators that enable resources to be used efficiently while ensuring the quality of study data. By regularly reviewing trial sites based on the risks identified, we ensure that potential problems are identified and resolved at an early stage.
Our experts identify potential risks in the early phases of the clinical trial. We develop preventive measures to minimize risks and avoid interruptions in the course of the trial. Through continuous risk assessment and monitoring, we ensure that risks are always kept in view and actively managed.
We provide you with comprehensive support in preparing for regulatory audits and inspections. Our experts review your study documentation and monitoring processes to ensure that all GCP standards are met. We also support you during audits and inspections to ensure the compliance of your clinical trials.
We offer specialized training for your study personnel to ensure that all monitoring activities are conducted to the highest standards. Our training covers compliance with GCP guidelines and proper documentation of monitoring activities. Through workshops on the implementation and improvement of monitoring strategies, we contribute to the quality assurance of your clinical trials.
Meet all regulatory requirements and secure market access.
Related topics for monitoring your clinical trials.
These complementary services help you to ensure the quality and compliance of your clinical trials and identify potential risks at an early stage:
