Comprehensive expertise in gastroenterology
In gastroenterology, clinical trials play a crucial role in the development of new therapies and the improvement of existing treatment options. As a specialized contract research organization (CRO), Mediconomics supports companies and research institutions in conducting clinical trials.
Continuous safety monitoring
Our experienced team has extensive knowledge in gastroenterology and can conduct studies in a variety of indications such as Crohn’s disease, ulcerative colitis, irritable bowel syndrome, liver disease and many more. We work closely with physicians, clinics and research groups to ensure that studies are planned and conducted to the highest standards.
Specialized expertise in various indications:
- Inflammatory bowel diseases (IBD): Crohn’s disease and ulcerative colitis are complex diseases for which we have extensive experience in conducting clinical trials. We work with leading experts to develop innovative therapies and improve existing treatment options.
- Functional gastrointestinal disorders: Irritable bowel syndrome, constipation, diarrhea and other functional disorders require a holistic approach to research. Our team specializes in the development of new therapies that are tailored to the individual needs of patients.
- Liver diseases: From chronic hepatitis to advanced liver damage such as cirrhosis and hepatocellular carcinoma, we cover a broad spectrum of liver diseases. We work with hepatologists to evaluate innovative treatment strategies and improve patients’ quality of life.
- Gastrointestinal cancers: Colorectal carcinoma, esophageal carcinoma, gastric carcinoma and other gastrointestinal tumor diseases require close collaboration between oncologists and gastroenterologists. Our team supports the development of new therapies and early detection measures to improve the prognosis of patients.
Compliance with strict regulatory requirements
Clinical trials in gastroenterology are subject to strict regulatory requirements that must be adhered to in order to ensure the safety of the subjects and the integrity of the data. Mediconomics has extensive experience in complying with all relevant regulations such as Good Clinical Practice (GCP), the German Medicinal Products Act (AMG) and the German Medical Devices Implementation Act (MPDG) and provides support in the submission of approval applications and cooperation with authorities.
Comprehensive expertise in regulatory affairs
Our experienced Regulatory Affairs team ensures that all regulatory requirements are met:
Advice and guidance: We provide comprehensive regulatory advice and guidance throughout the course of study to ensure that all requirements are met.
Approvals, changes, notifications and reporting: Our Regulatory Affairs team takes care of obtaining and maintaining all necessary approvals, applying for changes, reporting incidents and preparing reports.
Close cooperation with authorities: We work closely with the relevant authorities such as the BfArM and the PEI to ensure that the studies run smoothly and meet all requirements
Official reporting obligations
Our experts ensure the timely submission of Individual Case Safety Reports (ICSRs) to the relevant authorities via EudraVigilance. We ensure that all regulatory requirements are met and prepare you optimally for inspections. We offer:
- Timely reporting of ICSRs to authorities and EudraVigilance
- Preparation and support for inspections
- Creation and maintenance of standard operating procedures (SOPs)
Quality management and risk management
To ensure compliance with regulatory requirements, we have implemented a comprehensive quality management and risk management system:
Quality management: Our ISO 9001:2015-certified quality management system ensures that all processes are standardized and controlled.
Risk management: We conduct a systematic risk assessment to identify and minimize potential risks to study participants and data integrity.
Our extensive expertise in regulatory affairs and our quality and risk management system enable us to ensure that our clinical trials in gastroenterology meet all regulatory requirements. Our goal is to ensure the safety of the subjects while ensuring the integrity of the study data to achieve high-quality results.
Innovative technologies for efficient studies
Mediconomics uses state-of-the-art technologies to optimize the conduct of clinical trials in gastroenterology. This includes electronic data capture (EDC) systems and tools for decentralized study conduct. By using innovative approaches, we can improve data quality, accelerate patient recruitment, reduce costs and ultimately improve patient care. Our goal is to continuously increase the efficiency and quality of our studies through the use of innovative approaches and thus contribute to the development of innovative therapies.
Our EDC system enables efficient and error-free data collection:
Real-time data validation: Integrated plausibility checks detect and correct errors and inconsistencies in the data while it is being recorded.
Automated data analyses: Our EDC system performs regular data analyses and generates reports that highlight trends and anomalies.
Secure data transmission: All data is transmitted and stored in encrypted form to ensure the confidentiality and integrity of the information.
Global reach and local expertise
As a multinational company, Mediconomics has a global network of test centers and experts. At the same time, we place great emphasis on local expertise and work with experienced gastroenterologists and research groups in the respective countries. This combination of global reach and local expertise allows us to conduct studies in different regions while taking into account the specific requirements and characteristics of each market.
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
- Mediconomics has implemented a comprehensive quality management and risk management system to ensure quality and safety in clinical trials:
- Our ISO 9001:2015 certified quality management system ensures that all processes are standardized and controlled to guarantee consistent quality.
- We conduct a systematic risk assessment to identify potential risks to study participants and data integrity at an early stage and take measures to minimize them.
- Our experienced monitoring team (CRAs) ensures that the studies are conducted according to GCP, regulatory requirements and study protocol to ensure subject safety
Our experienced Regulatory Affairs team ensures that the relevant regulations such as GCP, AMG and MPDG are complied with. We support customers with the submission of approval applications and cooperation with authorities.
- During the course of a clinical trial, there may be changes to the study protocol, the investigational medicinal product or other aspects. Mediconomics has established processes to deal with such changes:
- We advise on the necessity and type of changes.
- We prepare the necessary documents for the application for changes with the authorities and ethics committees.
- Our project management team coordinates the implementation of the changes in the test centers.
- We communicate the changes transparently to all those involved.
This structured approach ensures that changes are implemented efficiently and in compliance with regulatory requirements during the course of the study.