Ensuring data integrity
Our monitoring team regularly checks the data collected at the test centers. We ensure that:
- All relevant data is recorded completely and correctly
- Deviations from the study protocol are documented and evaluated
- Corrective measures are taken in the event of deviations
This proactive monitoring enables us to identify and solve problems at an early stage before they affect data quality.
Continuous data monitoring
We use state-of-the-art technologies such as electronic check forms (eCRF) and data management systems to continuously monitor the data. This enables us to:
- Recognize deviations and discrepancies immediately
- Proactively report missing or invalid data
- Initiate data cleansing measures
This continuous monitoring enables us to ensure data quality throughout the entire course of the study.
Documentation and reporting
All monitoring activities and results are carefully documented. We create detailed reports that:
- Document all checks and measures carried out
- Record deviations and corrective measures
- Make recommendations for further steps
These reports serve as proof of the quality of the data and compliance with the study protocol. They also form the basis for communication with investigators, sponsors and authorities.
Protection of patient rights and safety
The safety and well-being of trial participants is our top priority. We work closely with investigators and ethics committees to ensure that the rights and welfare of patients are protected at all times.
Close cooperation with investigators and ethics committees
To ensure the protection of patient rights and safety, we work closely with investigators and ethics committees. We inform them regularly about:
- Security problems and measures taken
- Changes to the study protocol or patient information
- Results of the monitoring and data review
Only through this close coordination can we ensure that the interests of patients are protected at all times.
Compliance with regulatory requirements
Clinical studies are subject to strict regulatory requirements, which we take into account in our monitoring.
Compliance with Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international quality standard for the planning, conduct, documentation and reporting of clinical trials. Our monitoring team ensures that:
- All study participants give informed consent
- Adverse events are properly documented and reported
- All data is recorded completely, correctly and comprehensibly
Compliance with relevant laws and regulations
Clinical trials are subject to a large number of laws and regulations, which can vary depending on the type of trial and test substance. By complying with these regulations, we minimize legal risks and contribute to the protection of trial participants. Our monitoring team ensures that:
- The relevant regulatory requirements for the respective project are complied with
- All necessary approvals from the relevant authorities have been obtained
- Data protection requirements are met
Through our quality-assured monitoring of regulatory requirements, we help to ensure that clinical trials are conducted safely, to a high standard and in compliance with all relevant laws and regulations. We work closely with the relevant authorities and ethics committees to ensure the integrity of study results and facilitate the approval of innovative products.
Optimization of the study processes
In addition to ensuring data quality and patient safety, we also optimize the processes in the trial centers. We identify areas where efficiency and effectiveness can be improved and develop customized solutions. Through these optimizations, we help to reduce the costs and duration of studies and keep the quality of the results optimal.
Optimization of patient recruitment and retention
Efficient patient recruitment is crucial to the success of a clinical trial. Our monitoring team works closely with the trial centers to:
- Develop suitable recruitment strategies that are tailored to the target group
- Identify and remove barriers to participation
- Create incentives and support for study participants to improve retention
Optimization of data acquisition
Data collection is a critical step in the conduct of a clinical trial. Our monitoring team works with the trial sites to:
- Use electronic data capture (EDC) systems that improve data quality and reduce errors
- Develop standardized processes and training for study personnel
- Implement regular reviews and feedback loops to monitor and improve data quality
Optimization of communication
Effective communication between all parties involved is crucial for the smooth running of a clinical trial. Our monitoring team relies on:
- Regular meetings and telephone conferences with the test centers to discuss progress, problems and solutions
- Clear communication channels and escalation strategies to identify and resolve problems quickly
- Transparency and open exchange to promote trust and cooperation between all parties involved
Locations
Maps
contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
Clinical monitoring is critical to ensure the integrity and validity of study results. It helps to identify and resolve problems at an early stage, protect patient safety and ensure compliance with all relevant laws and regulations.
The optimization of study processes helps to reduce the costs and duration of studies without compromising on quality. Through more efficient processes and improved communication, problems can be identified and solved more quickly, which leads to an acceleration of study execution.