Contract Research Organization - CRO

Mediconomics as your partner for clinical research

A Contract Research Organization (CRO), also known as a contract research organization, is a specialized company that supports pharmaceutical, biotechnology and medical technology companies in the planning, execution and evaluation of clinical trials.

Mediconomics GmbH, with headquarters in Hanover and international subsidiaries, has established itself as a leading full-service CRO with over 420 successfully completed clinical research projects since 1999. The company is characterized by systematic, tailor-made solutions and offers comprehensive services from study conception to approval – always in compliance with the highest quality standards and regulatory requirements.

Tasks and range of services of a contract research organization

Study design and project planning

Contract Research Organizations undertake the comprehensive planning of clinical trials, including the definition of study objectives and endpoints, statistical planning and the preparation of detailed study protocols. This phase includes the selection of suitable study populations, the precise determination of the required number of participants through case number calculations and the strategic selection of optimal study centers. Mediconomics brings over two decades of experience to this critical phase and creates customized study plans that meet both scientific and regulatory requirements.

The planning phase requires a deep understanding of both the scientific question and the regulatory landscape. Modern CROs such as Mediconomics use advanced statistical methods and proven design principles to develop studies that deliver meaningful results while minimizing risks to participants. Expertise spans all study phases from Phase I to Phase IV as well as specialized areas such as Post-Market Clinical Follow-up (PMCF) for medical devices.

Study implementation and management

Conducting clinical trials requires precise coordination and continuous monitoring of all trial activities. CROs ensure that all aspects are conducted according to the approved study protocol and in compliance with Good Clinical Practice (GCP) standards. This includes the recruitment and management of study participants, the implementation of the planned interventions and the systematic collection and management of data.

Mediconomics has a multinational expert team of experienced physicians, scientists, statisticians and project managers who coordinate all aspects of study execution. The company uses state-of-the-art technologies for data collection and ensures the highest data quality through structured working methods and quality-assured environments. The systematic approach enables transparency, flexibility and fast response times throughout the duration of the study.

Data management and statistical analysis

The collection, storage, management and statistical analysis of trial data is at the heart of successful clinical research. CROs create specialized Case Report Forms (CRFs), implement robust database systems and perform continuous quality control to ensure data integrity and completeness. Statistical analysis is performed according to predefined Statistical Analysis Plans (SAP) and using advanced biostatistical methods.

Mediconomics places particular emphasis on data integrity, traceability and transparency throughout the study lifecycle. The company implements efficient processes and uses advanced technologies to ensure high-quality, reproducible results. The team’s biostatistics expertise enables sound statistical analyses that help to derive meaningful conclusions from the clinical data.

Mediconomics as a specialized contract research organization

Comprehensive range of services

Mediconomics positions itself as a full-service CRO offering a comprehensive range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies. The range of services includes regulatory affairs, clinical research, data management, product development, pharmacovigilance and medical writing. This integrative approach makes it possible to manage projects from a single source and to make optimum use of synergies between the various specialist areas.

Mediconomics’ regulatory services cover all areas of regulatory affairs, from clinical trials to drug approvals. The company assists with scientific and regulatory consultations, the management and submission of national and international eCTDs as well as approval procedures in various categories. Its expertise covers the entire life cycle management of marketing authorizations, including variation notifications and renewals.

International presence and expertise

With offices in Germany, Denmark, Switzerland, the United Kingdom and the USA, Mediconomics operates in an international network and has extensive knowledge of various regulatory environments. This international presence enables the company to efficiently coordinate multinational studies while taking local regulatory specifics into account. The long-standing contacts with relevant authorities worldwide facilitate communication and accelerate approval procedures.

Quality assurance and certifications

Mediconomics maintains a certified quality management system in accordance with DIN EN ISO 9001:2015, which ensures the continuous improvement of all processes and services. Activities are governed by standardized Standard Operating Procedures (SOPs), which are regularly updated to meet changing regulatory requirements. Quality management is one of the foundations of the company’s success and ensures that only the highest quality results leave the company.

The continuous training of the interdisciplinary team ensures that all employees remain up to date with the latest scientific and regulatory developments. Mediconomics is a member of relevant professional organizations such as the European Medical Writers Association (EMWA), which underlines its commitment to maintaining the highest scientific and ethical standards. This systematic approach to quality assurance has earned the company an excellent reputation over more than two decades.

Quality measures and monitoring at Mediconomics

Clinical Research Associates and Monitoring

Mediconomics utilizes experienced Clinical Research Associates (CRAs) to ensure comprehensive site monitoring and adherence to GCP protocols. Clinical monitoring ensures that all aspects of the study are conducted to the highest standards and includes regular review of study sites, validation of data quality and ensuring proper storage of investigational drugs or products.

A key task of the CRAs is source data verification (SDV), in which source data is compared with the case report forms to ensure the accuracy and completeness of the study data. The Mediconomics monitoring team systematically checks the maintenance of patient identification lists, the correct documentation of informed consent forms and the legally compliant reporting of serious adverse events (SAEs). In the event of discrepancies or questions, queries are immediately sent to the trial centers to ensure the highest possible data quality.

Audit preparation and regulatory compliance

Mediconomics carries out both internal and external quality controls and prepares planned audits professionally. The company assumes the tasks of the sponsor in conducting audits and systematically evaluates study centers with regard to their suitability and performance. The comprehensive documentation of all processes and compliance with regulatory requirements ensure that audits are passed successfully.

The expertise in regulatory affairs enables Mediconomics to support clients in the submission of study documents to competent authorities such as BfArM or PEI. This includes the preparation of study reports and safety reports, the submission of clinical trial applications and ongoing collaboration with regulatory authorities. The proactive approach to regulatory compliance minimizes delays and increases the likelihood of successful approval procedures.

Why Mediconomics is the ideal CRO partner

Over 20 years of experience and a proven track record

Since its foundation in 1999, Mediconomics has become a trusted partner for over 420 successfully completed clinical research projects. This extensive experience spans all phases of clinical trials and various therapeutic areas, from pharmaceuticals and medical devices to specialized areas such as nutraceuticals, dietary supplements and homeopathic medicines. The company’s proven track record demonstrates its ability to bring even complex and challenging projects to a successful conclusion.

Mediconomics’ core philosophy, developed over more than two decades of successful client relationships, is to keep the company small enough to offer flexible, customized solutions, but large enough to handle complex situations. This balanced approach makes it possible to serve both start-up and established pharmaceutical companies with the same care and expertise.

Customized solutions and flexible support

Mediconomics understands that every research project has unique requirements and challenges. The company develops systematic and customized solutions that are tailored to the specific needs of each client. Depending on the requirements of each study, clients can engage Mediconomics to conduct the entire project or just specific areas. This flexibility makes it possible to make optimum use of resources and control costs.

Comprehensive expertise in medical writing and documentation

Mediconomics has particular expertise in medical writing, a critical success factor for the successful communication of clinical and scientific information. The experienced medical writing team produces customized documentation ranging from study designs and protocols to Investigational Medicinal Product Dossiers (IMPD), integrated study reports and expert reports for eCTDs. The precision and accuracy of Mediconomics’ medical writing ensures that all documents meet the highest scientific and ethical standards.