Clinical Research – Professional services for Clinical Trials

Our Clinical Research services include:

  • Project management
  • Design development and protocol creation
  • Selection of investigational sites and investigators
  • Application submission and regulatory support
  • Recruitment support
  • Monitoring
  • Quality assurance
  • Site management
  • Statistics from conception to analysis
  • Preparation of the Integrated Final Report (IFR)
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Clinical Studies with Mediconomics

Mediconomics offers you bespoke solutions for your clinical studies involving pharmaceuticals and medical devices. Our experienced team supports you from planning to execution and evaluation of your studies, always adhering to the highest quality standards and regulatory requirements.

Project Management

A clinical study is a complex project that requires various specialised areas for professional implementation. From preparation through execution to evaluation, efficient coordination of diverse experts is crucial.

Our project managers ensure that your clinical study is conducted efficiently, on schedule, and within budget. They will be your central points of contact and ensure that all aspects of your study integrate seamlessly. You benefit from our structured approach, ensuring transparency, flexibility, and rapid response times.

Study Planning and Design

We create individually tailored study protocols, perform sample size calculations, and select appropriate endpoints to optimally design your clinical study. Our expertise includes:

  • Creation of customised study protocols
  • Conducting feasibility studies
  • Selection of suitable endpoints and biomarkers
  • Sample size calculation and statistical planning

Regulatory Affairs

Our team provides comprehensive advice on regulatory requirements and supports you with applications and submissions. We offer:

  • Consultation on regulatory requirements
  • Support/execution of application preparation and submission
  • Communication with authorities and ethics committees
  • Preparation and support for audits and inspections

Site Management

Effective site management is crucial for the smooth execution of your clinical study. We ensure professional implementation through the following aspects:

  • Identification and qualification of suitable study sites including contract and budget negotiations. We consider factors such as qualification and experience, resources and infrastructure, motivation and commitment, compliance and quality, and site-specific factors.
  • Training and support of study personnel: Providing comprehensive training and continuous assistance for study personnel.
  • Monitoring and quality assurance to ensure compliance with GCP, study protocol, and regulatory requirements.
Our experienced CRAs work closely with study sites to ensure high data quality and compliance with all regulatory requirements. By employing state-of-the-art technologies and targeted methods, we optimise the efficiency and quality of site management.

Patient Recruitment and Retention

Development and implementation of strategies for efficient recruitment and retention of study participants through:

  • Target population analysis: Identification and analysis of the target patient population based on study design and inclusion/exclusion criteria.
  • Advertising strategies: Development and implementation of targeted advertising campaigns across various channels such as social media, online platforms, print media, and local health organisations.
  • Partnerships: Collaboration with local patient organisations to build trust and reach potential participants.
  • Patient communication: Creation of comprehensible and informative materials that inform potential participants about the study and motivate participation.
  • Monitoring and adaptation: Continuous monitoring of recruitment progress and adjustment of strategies to ensure recruitment goals are met.

Clinical Monitoring

We offer a wide range of monitoring services to ensure the quality, integrity, and safety of your clinical study:

  • On-site monitoring: Regular on-site visits to verify study conduct, data quality, and patient safety
  • Remote monitoring: Remote surveillance of study data and processes using digital technologies
  • Central monitoring: Continuous analysis of study 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 in accordance with GCP, regulatory requirements, and the study protocol. We assist in selecting and training study centres, monitor patient recruitment, verify source data, and ensure adherence to the study protocol. Our goal is to maximise data integrity and optimise monitoring efficiency.

Clinical Data Management

We use validated eCRF systems and ensure data quality assurance as well as 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 page on clinical data management.

Biostatistics

Our experts conduct complex statistical analyses and create interim analyses as well as final reports. Our services include:

  • Statistical consultation and experimental design
  • Conducting interim analyses
  • Creation of statistical final reports
  • Publication preparation and support

Procedure of Clinical Trials

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
  • Gastroenterology
  • Infectious diseases
  • Neurology
  • Urology
  • Dermatology
  • Rare diseases

Specialised Fields

Our expertise with biological agents and phytotherapeutics in these therapeutic areas is particularly noteworthy.
Through Medicoforum, our sister company for the certification of medical devices, we have extensive expertise in the field of medical device studies, including PMCF.
We are passionate about supporting research projects that are not solely conducted by the industry, which is why we have developed processes that are well suitedto supporting IITs, allowing sponsor-investigators to focus on clinical activities.

Various Study Types

Mediconomics conducts various types of clinical studies, including:
  • Phase I to IV studies
  • Medical device studies
  • Post-Market Clinical Follow-up (PMCF) studies
  • PASS, NIS, observational studies and registries

Our Technologies

eCRF and CTMS Systems

We employ state-of-the-art systems to ensure efficient and secure data collection and management.
  • Validated and contemporary eCRF systems
  • Integrated CTMS (Clinical Trial Management Systems)
  • Tools for remote monitoring and decentralised studies

Data Security

Our measures ensure the highest security standards and compliance. These include:
  • Encryption and secure data transmission
  • Regular security audits
  • GDPR-compliant data processing

Our Quality Standards

Certifications

We are ISO 9001 certified and maintain a comprehensive quality management system that secures our processes and thus ensures the smooth execution of your project.

Quality Assurance Processes

Internal audits and continuous improvements ensure the quality of our services.

Audit Experience

We have extensive experience with audits and inspections by authorities and sponsors. As a client, you are invited to take a closer look through an audit while you can rest assured that we are adequately prepared in case of regulatory inspections.

Our Flexibility

Tailored Solutions

Our solutions are as diverse as the unique clinical context they are made to address: We offer individual solutions for all project sizes and types.

Flexible Resource Allocation

We are flexible when your requirements change and adapt our resource planning to your needs. This way, we can also incorporate additional specialised areas when a broader focus is needed.

Quick Response Times

We do not operate waiting loops or ticketing systems. Instead, we rely on personal contacts who guarantee personal support and quick response times – , in either English or your preferred language.

Our Efficiency

Optimised Processes

Through our efficient processes and years of experience, we can optimise timelines and costs for our customers.

Transparent Pricing

We offer transparent and fair pricing without hidden costs.

FAQ – frequently asked questions

A CRO (Contract Research Organisation) 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 analysis of clinical trials. Working with a CRO like Mediconomics can help you save time and resources, efficiently fulfil regulatory requirements and benefit from specific expertise.

Mediconomics conducts various types of clinical studies, including:
  • Phase I to IV studies
  • Medical device studies
  • Post-Market Clinical Follow-up (PMCF) studies
  • PASS, NIS, observational studies and registries
We adapt our services to the specific requirements of each study.

Depending on the complexity, the time it takes to start a clinical trial also varies in terms of regulatory requirements and trial design.

Typically, the process from concept development to first patient enrolment takes between 3 and 12 months. e work closely with our clients to make this process as efficient as possible.

We rely on several quality assurance measures:
  • ISO 9001 certified processes
  • Regular internal and external audits
  • Continuous training for our staff
  • Use of validated systems and technologies
  • Strict adherence to GCP, ICH guidelines, and local regulations

Yes, we have experience in conducting international studies. Our global network of trial centres and researchers, as well as our multilingual team, enable us to efficiently coordinate and conduct studies in different countries. Our subsidiaries in Germany, Denmark, Switzerland, the UK and the USA are involved as needed.

The costs of a clinical study depend on various factors, such as the study design, the number of patients, the duration of the study and the services required.
We prepare an individual, transparent offer for each customer. Contact us for a detailed cost estimate for your specific project.

Our regulatory team offers comprehensive support, including:
  • Advice on current regulatory requirements
  • Preparation and submission of approval documents
  • Communication with authorities and ethics committees
  • Preparation and support for inspections

Yes, we offer our clients secure access to electronic data collection, which they can use to track the progress of their study in real time.

In addition, you will receive regular progress reports and have a dedicated project manager as a direct point of contact.

Our experienced team is prepared to respond flexibly to unexpected situations. We have established processes for risk management and rapid response. If problems arise, we will inform you immediately and work with you to develop strategies to ensure the integrity and progress of the study.

About clinical research

Clinical data are a prerequisite for marketing authorisation

Clinical research is essential basic biomedical research performed to improve medical treatment and is thus also a prerequisite for market approval. Therefore, clinical trials must be carried out with subjects to test and scientifically prove the efficacy and safety of medicinal products, medical devices and other treatment methods.

Strict regulations ensure the subject’s health

Preliminary trials are performed to prove that the health risk to which participants will be exposed is low and is outweighed by potential benefits. Before these trials may commence, a positive evaluation by the responsible ethics committee and approval by the federal authorities (BfArM or Paul Ehrlich Institute) are required. Clinical research is subject to numerous national and international regulations, according to which all trials must be conducted. These include the AMG (Medicines Act), MPDG (Medical Device Law Implementation Act) and the Declaration of Helsinki, GCP (Good Clinical Practice). A multinational research team including a range of experience and perspectives is beneficial, particularly as projects often involve several countries, each of which have different regulations which must be taken into account. In these cases, the European Clinical Research Infrastructure Network (ECRIN) provides support.

During clinical trials, the credibility and comprehensibility of all findings, observations and conclusions are critical. After all studies have been completed, an application for marketing authorisation is submitted to the competent regulatory authority.

In summary, the term clinical trial refers to any investigation conducted in humans to investigate or demonstrate clinical, pharmacological and/or other pharmacodynamic effects of investigational medicinal products and/or to determine any adverse reaction to investigational medicinal products and/or to investigate the absorption, distribution, metabolism and excretion of investigational medicinal products, to ascertain their safety and/or efficacy.

This includes clinical trials conducted in one or more investigational sites in one or more countries.

Generation and compilation of clinical data through GCP-standard compliant Clinical Trials:

There is currently no satisfactory therapy available for a large number of diseases. Drugs and medical devices are tested in clinical trials for their efficacy and safety. However, since the cost-benefit analysis of innovation is also of importance in addition to these medical aspects, a pharmacoeconomic evaluation is also relevant at this stage.

We have many years of experience in coordinating and conducting phase I-IV clinical trials in various therapeutic areas.

Mediconomics takes care of your clinical study entirely or in parts.

For instance: application, project management, monitoring, statistics and preparation of the final report.

Our multinational team assists you throughout study design and conduct, ensuring the highest quality data are obtained. Furthermore, we are specialists in the supervision of essential post-marketing studies, including PASS and NIS. In addition, we are proud to be listed in the BIOCOM directory and work closely with the Research Association of Drug Manufacturers (FAH) and the Institute of Clinical Research.

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Get in touch now

Call us on +49 511 560 9980 or use the contact form.

Request a non-binding offer or a free consultation.