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We provide full support at every stage of the study – from planning to the registration process. Contact us to discuss the details of cooperation.
What types of clinical and bioequivalence studies do you conduct?
Our company specializes in Phase I-IV clinical trials and bioequivalence studies of generic and biological drugs. We offer comprehensive support at every stage of the study.
What does the participant recruitment process look like?
The recruitment process is carried out in accordance with the highest ethical and regulatory standards. We use advanced selection methods to ensure an appropriate group of participants who meet the study’s inclusion criteria.
What data management systems do you use?
We use modern eCRF systems compliant with the requirements of 21 CFR Part 11 and GDPR. We ensure full data security and integrity.
Do you offer support with regulatory audits and inspections?
Yes, our expert teams provide full support in preparing for and conducting audits as well as regulatory inspections, including EMA and FDA.
What are the main benefits of working with your company?
We offer many years of experience, modern infrastructure, and a flexible approach to the sponsor’s individual needs. We ensure high-quality studies and on-time project delivery.
What pharmacokinetic analysis methods do you use in bioequivalence studies?
We use modern analytical methods, such as liquid chromatography coupled with mass spectrometry (LC-MS/MS), ensuring precise analysis of drug concentration in various biological matrices, including serum and plasma.
How do you ensure that studies comply with GCP and GLP principles?
Our studies are conducted in accordance with ICH-GCP and GLP requirements, which includes regular internal audits, staff training, and the use of quality control systems.
What are the key challenges in conducting bioequivalence studies and how do you minimize them?
The key challenges are proper recruitment of participants, control of pharmacokinetic variability, and ensuring the consistency of analytical methods. We use advanced recruitment algorithms, precise analytical methods, and rigorous control protocols.
How long does a typical bioequivalence study take?
The duration depends on the product’s characteristics, but a typical bioequivalence study lasts from a few weeks to several months, including recruitment, drug administration, and data analysis.
What do you consider key when conducting clinical and bioequivalence studies?
The most important aspects are precise planning of the study protocol, proper recruitment of participants, strict control over drug administration, and monitoring of pharmacokinetic and pharmacodynamic parameters. The use of modern analytical methods and ensuring full compliance with GCP and GLP regulations is also of key importance.
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