A contract research organization (CRO; German: Auftragsforschungsinstitut) is a company that supports, pharmaceutical and biotechnology companies, among others, by providing research services that are outsourced on a contractual basis. Contract research organizations can offer a wide range of services, including drug development, clinical trials, bioanalytical research, consulting services, data management and statistical analysis.

The areas of responsibility of a contract research organization include, among other things:

• Conducting clinical trials: CROs are often involved in the planning, organization and documentation of clinical trials (translation into German: klinische Studien) at all stages of drug development, from phase I (studies on a small group of healthy volunteers) to phase IV (post-marketing studies after the drug has been launched).
• Drug development: Contract research organizations provide services for chemical synthesis, drug formulation, toxicology testing and the initial phases of preclinical studies.
• Marketing authorization support: Support in preparing documents and liaising with regulatory authorities such as the FDA in the USA or the EMA in Europe to ensure that all aspects of development and testing comply with applicable regulations and standards.
• Pharmacovigilance: Monitoring the safety of a product during the entire clinical trial process as well as after its marketing authorization (German: Zulassung).
• Data management and statistics: Collecting, analyzing and interpreting research data and preparing reports and publications.

Advantages of working with a contract research organization:

• Efficiency: Outsourcing research and development work to CROs enables companies to reduce the cost and time required to conduct clinical trials and develop new products.
• Know-how: Contract research organizations provide access to highly skilled professionals and modern equipment, which is particularly important for small and medium-sized enterprises that do not have the internal resources to conduct large scale research .
• Global reach: Many CROs have offices and laboratories in different countries, allowing them to conduct multi-center international clinical trials and expedite regulatory approval in different regions.

Contract research organizations play an important role in today’s pharmaceutical and biotechnology industry as they provide the necessary infrastructure and expertise to accelerate the research and development of new active pharmaceutical ingredients.

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