BIOCAD Clinical Trials

• to inform potential participants and physicians about BIOCAD’s clinical studies being conducted in Russia and other countries;
• to help potential participants to quickly and easily find a study center where BIOCAD conducts a clinical study they want to participate in.

BIOCAD conducts its clinical studies in Russia, the Republic of Belarus, China, India, Hungary, and Slovakia.

The number of clinical studies conducted by BIOCAD has been increasing annually, from 17 projects in 2020 to as much as 37 in 2022. In 2023, the company will be conducting 49 studies.

BIOCAD conducts clinical studies of treatments for diseases with a high social impact, e.g. spinal muscular atrophy, neuroblastoma, axial ankylosing spondylitis, melanoma, non-small cell lung cancer, multiple myeloma, cervical cancer, systemic scleroderma, Devic's disease and others.

The number of participants in clinical studies of BIOCAD’s products has also increased, from 1,450 in 2020 to 2,353 in 2021. In 2023, more than 3,500 subjects will be enrolled in our studies.

For each investigational medicinal product, safety studies begin as early as at the time of its creation in a laboratory test tube. Investigators analyze existing global experience in creating analogs of the product and simulate its safety profile. Non-clinical animal studies are performed at the next step. All these steps enable establishing the safe dose of the product for studies in humans.

In each clinical study, an independent data monitoring committee (IDMC) reviews its conduct, including safety data and key efficacy outcomes, and advises the sponsor whether to continue, terminate, or modify the study.

In the Russian Federation, clinical studies of BIOCAD comply with protocols approved by the Ethics Committee of the Ministry of Health, the Ministry of Health of the Russian Federation, and independent ethics committees.

With its specific features and requirements, each clinical study is subject to internal and external independent audits. Audits are performed in all study centers and BIOCAD’s divisions involved in the clinical development program. Mandatory audits of vendors for clinical studies are also conducted.

BIOCAD is responsible for the safety of patients participating in its clinical studies. Studies comply with the scientific and ethical principles, Decision No. 79 On Approval of the Rules for Good Clinical Practice of the Eurasian Economic Union of November 03, 2016, and Order No. 200н of the Ministry of Health of the Russian Federation On Approval of the Rules of Good Clinical Practice dated April 1, 2016.

All subjects participating in the clinical studies of BIOCAD are insured to cover the expenses associated with medical risks.

For each participant, his/her clinical status is monitored by physicians according to the clinical study protocol.

Healthy volunteers participating in phase I clinical studies of BIOCAD may be reimbursed.