Our expertise for clinical studies
- Design development and test plan creation
- Selection of test sites and investigators
- Application and regulatory support
- Project management
- Recruitment support
- Monitoring
- Quality assurance
- Site Management
- Statistics from concept to evaluation
- Preparation of the integrated final report
Services for clinical research
Mediconomics offers you customized solutions for your clinical studies with medicinal products and medical devices. Our experienced team supports you from the planning to the execution and evaluation of your studies, always in compliance with the highest quality standards and regulatory requirements.
Project management
A clinical trial is a complex project that requires various specialist areas for professional implementation. It is therefore important to coordinate the various experts efficiently, from preparation to implementation and evaluation.
Our project managers ensure that your study is carried out efficiently, on time and within budget. They are the central point of contact and ensure that all parts of your project are seamlessly integrated. You benefit from our structured approach, which guarantees transparency, flexibility and fast response times.
Planning and design
We create individually tailored study plans, perform case number calculations and select suitable endpoints to optimize your research project. Our expertise includes:
- Creation of individual test plans
- Carrying out feasibility studies
- Selection of suitable endpoints and biomarkers
- Case number calculation and statistical planning
Regulatory Affairs
Our team will provide you with comprehensive advice on regulatory requirements and support you with applications and submissions. We offer:
- Advice on regulatory requirements
- Support / implementation of the preparation and submission of applications
- Communication with authorities and ethics committees
- Preparation and monitoring of audits and inspections
Site Management
Effective site management is crucial for the smooth running of your clinical trial. We ensure professional implementation by means of the following aspects:
- Identification and qualification of suitable inspection bodies, including contract and budget negotiations. Among other things, we take into account qualifications and experience, resources and infrastructure, motivation and commitment, compliance and quality, test center-specific factors
- Training and support for test personnel , e.g. by providing training and ongoing support for test personnel
- Monitoring and quality assurance to ensure compliance with GCP, study protocol and regulatory requirements.
Our experienced CRAs work closely with the inspection bodies to ensure high data quality and compliance with all regulatory requirements. By using the latest technologies and targeted methods, we optimize the efficiency and quality of site management.
Patient recruitment and retention
Development and implementation of strategies for efficient recruitment and retention of patients and test subjects:
- Target population analysis: Identification and analysis of the target patient population based on the design and inclusion/exclusion criteria.
- Advertising strategies: Development and implementation of targeted advertising campaigns via various channels such as social media, online platforms, print media and local health organizations.
- Partnerships: Working with local patient organizations to build trust and reach potential participants.
- Patient approach: Creation of comprehensible and informative materials that inform potential participants and motivate them to take part.
- Monitoring and adaptation: Continuous monitoring of recruitment progress and adaptation of strategies to ensure that recruitment targets are met.
Clinical monitoring
We offer a wide range of monitoring services to ensure quality, integrity and security:
- On-site monitoring: regular on-site visits to check implementation, data quality and patient safety
- Remote monitoring: remote monitoring of study data and processes using digital technologies
- Central monitoring: Continuous analysis of key data for early detection of trends and risks
- Risk-based monitoring: adjustment of monitoring intensity based on identified risks
Our experienced monitoring team (CRAs) ensures that your study is conducted according to GCP, regulatory requirements and study protocol. We assist in the selection and training of trial sites, monitor patient recruitment, verify source data and ensure compliance with the protocol. Our goal is to maximize data integrity and optimize monitoring efficiency.
Clinical data management
We use validated eCRF systems and ensure data quality assurance and GDPR-compliant data management. Our services include:
- Design and implementation of eCRFs
- Database management and maintenance
- Quality assurance and data validation
- GDPR-compliant data management
For more information, please read our specialist page for clinical data management.
Biostatistics
Our experts carry out complex statistical analyses and prepare interim analyses and final reports. Our services include
- Statistical consulting and experimental design
- Implementation of interim analyses
- Preparation of final statistical reports
- Publication preparation and support
Procedure of a clinical trial
Our expertise
More than 25 years of experience
In our more than 25 years of project work, we have successfully completed numerous studies in almost all relevant therapeutic areas, including
- Oncology
- Cardiology
- Gastroenerology
- Infectious diseases
- Neurology
- Urology
- Dermatology
- Rare diseases
Special fields
Our expertise with biological active ingredients and phytotherapeutics in these therapeutic areas is particularly noteworthy.
Different types of studies
Mediconomics conducts various types of clinical trials, including:
- Phase I to IV
- Medical device studies
- Post-Market Clinical Follow-up (PMCF)
- PASS, AWB, NIS, observational studies and registers
Our technologies
eCRF and CTMS systems
We use state-of-the-art systems to ensure efficient and secure data collection and management.
- Validated and up-to-date eCRF systems
- Integrated CTMS (Clinical Trial Management Systems)
- Tools for remote monitoring and decentralized studies
Data security
Our measures ensure the highest security standards and compliance. These include
- Encryption and secure data transmission
- Regular safety audits
- GDPR-compliant data processing
Our quality standards
Certifications
We are ISO 9001 certified and maintain a comprehensive quality management system that ensures our processes and thus the smooth running of your project.
Quality assurance processes
Internal audits and continuous improvements ensure the quality of our services.
Audit experience
Our flexibility
Customized solutions
The approaches we use to develop solutions are as varied as the initial situations: We offer individual solutions for all project sizes and types.
Flexible resource allocation
We are flexible if your requirements change and adapt our resource planning to your needs. In this way, we can also add other specialist areas if a broader focus is required.
Fast response times
We do not operate waiting loops or ticketing systems. Instead, we rely on personal contacts who guarantee personal support and fast response times – in the local language or in English, of course.
Our efficiency
Optimized processes
Our efficient processes and many years of experience enable us to optimize costs for our customers.
Transparent pricing
We offer transparent and fair pricing with no hidden costs.
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
A CRO (Contract Research Organization) is a company that provides services for the pharmaceutical and biotechnology industry as well as for medical technology companies. CROs assist in the planning, execution and evaluation of clinical trials. Working with a CRO like Mediconomics can help you save time and resources, efficiently meet regulatory requirements and benefit from specific expertise.
- Phase I to IV
- Medical device studies
- Post-Market Clinical Follow-up (PMCF)
- PASS, AWB, NIS, observational studies and registers
Depending on the complexity, the time it takes to start a clinical trial also varies in terms of regulatory requirements and study design.
Typically, the process from concept development to first patient inclusion takes between 3 and 12 months. We work closely with our customers to make this process as efficient as possible.
- ISO 9001-certified processes
- Regular internal and external audits
- Continuous training for our staff
- Use of validated systems and technologies
- Strict compliance with GCP, ICH guidelines and local regulations
Yes, we have experience in conducting international studies. Our global network of trial centers and researchers as well as our multilingual team enable us to efficiently coordinate and conduct research in different countries. Our branches in Germany, Denmark, Switzerland, the UK and the USA are involved as required.
The cost of a clinical trial depends on various factors, such as study design, number of patients, duration of the study and services required.
We create an individual, transparent offer for every customer. Contact us for a detailed cost estimate for your specific project.
- Advice on current regulatory requirements
- Preparation and submission of approval documents
- Communication with authorities and ethics committees
- Preparation and monitoring of inspections
Yes, we offer our clients secure access to electronic data collection on request, allowing them to track the progress of their study in real time.
In addition, you receive regular progress reports and have a dedicated project manager as your direct contact.
Our experienced team is prepared to react flexibly to unexpected situations. We have established processes for risk management and crisis intervention. In the event of problems, we inform you immediately and work together to develop solution strategies to ensure integrity and progress.
About clinical research
No approval without clinical data
Clinical research is important basic biomedical research and is therefore also a prerequisite for approval and aims to improve medical treatment. To this end, clinical studies are conducted with test subjects in order to test and scientifically prove the effectiveness and safety of medical devices, drugs and treatment methods.
Regulations protect the health of test subjects
Preliminary trials must prove that the participants are only exposed to a low health risk. In addition, a positive vote by the responsible ethics committee and approval by the higher federal authorities (BfArM or Paul Ehrlich Institute) is required before clinical trials can even begin. Clinical research is subject to numerous national and international regulations according to which all trials must be conducted. These include the AMG (German Medicinal Products Act), MPDG (Medical Devices Implementation Act) and the Declaration of Helsinki, GCP (Good Clinical Practice). Putting together a multinational research team can be useful for certain issues. A particular challenge here is the consideration of all regulations of the countries involved. The European Clinical Research Infrastructure Network (ECRIN) provides support in this regard.
In summary, a clinical trial is any examination carried out on humans in order to
- to research or demonstrate clinical, pharmacological and/or other pharmacodynamic effects of investigational medicinal products
- and/or any side effect of investigational medicinal products
- and/or to investigate the absorption, distribution, metabolism and excretion of investigational medicinal products,
- with the aim of ascertaining their safety and/or efficacy.
This includes clinical trials conducted in one or more trial sites in one or more Member States.
Conducting clinical studies according to GCP standards
There is currently no satisfactory therapy for a large number of diseases. Drugs and medical devices are tested for their efficacy and safety in clinical trials. As the cost-benefit analysis of an innovation is of paramount importance alongside these medical aspects, the pharmacoeconomic evaluation also becomes increasingly relevant at this stage.
Mediconomics implements your clinical project in whole or in part.
Our multinational team will support you throughout the design and execution, ensuring that the highest quality data is obtained. In addition, we are experts in the management of post-marketing studies, including PASS and NIS.
We are a proud member of the BIOCOM registry and work closely with the Research Association of Pharmaceutical Manufacturers (FAH) and the Institute of Clinical Research (ICR).