Procurement of comparative products

In clinical drug research, comparator products are essential for assessing the efficacy and safety of new drugs.

Comparator products (control products or placebos) serve as a reference for assessing the effect of the investigational medicinal product. They enable researchers to assess the therapeutic effect of the new drug in comparison with established therapies or a neutral substance. Their use contributes to an accurate, objective and reliable assessment of the efficacy of the investigational product.

The comparator products are usually obtained from companies that specialise in providing medicines for clinical trials. These companies ensure that the comparator products meet the quality requirements and specifications of the clinical trial. They work closely with research teams and sponsors to provide the appropriate comparator products in a timely manner.

Sourcing comparator products requires careful planning and coordination. Researchers need to decide early on which comparator product is optimal for their study. This depends on several factors, including the nature of the disease or condition, the patient population being studied, and ethical guidelines for the use of placebos. The exact amount and dosage of the comparator is also determined to ensure that the trial is conducted correctly.

Before conducting a clinical trial, an application must be submitted to the relevant ethics committees and the competent authorities. These applications contain detailed information about the planned study, including the planned use of comparator products. Approval is granted after a full review of the ethical and legal aspects of the trial.

To ensure the safety of the study participants, it is of utmost importance that the procurement of comparator products complies with strict regulations and quality standards. Suppliers of these products are subject to strict control mechanisms and quality assurance processes to ensure that the comparator products meet regulatory and quality requirements.

If you have any questions or require additional information on sourcing comparator products for clinical trials, please do not hesitate to contact us.

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EudraCT and NCT number

In the field of clinical research, two identification numbers play a central role: the EudraCT number and the NCT number.