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    Ascent CRS is a full-service CRO that provides an entire range of clinical research services from Phase I and Proof of Concept to Phase III-IV and Bioequivalence studies.

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Bioequivalence

Having successfully conducted more than 50 BE studies in our units, we at Ascent have developed a strong understanding of the various requirements that pharmaceutical companies of all sizes from small to large may have.

One of the main requirements that all sponsors have in common is being first to market. Understanding this we have helped global companies bring their products to markets sooner than they have expected.

Understanding each company we have worked with has strict timelines, budget and very specific requirements for conducting BE studies, we have developed dedicated facilities that are specifically designed for them: long confinement, intensive-care units, 24/7 medical personal availability, state-of-the-art equipment.

These units are located in Moscow, Russia and Tbilisi, Georgia. Both of them have an exceptional ICH-GCP certified staff on board, all the needed equipment for conducting and monitoring trials and have been numerously audited by sponsors and independent auditors. Providing best locations and facilities possible ensures a lower cost and fast start-up environment for every trial.

Although we have our own dedicated units and highly experienced BE staff, for highly complex designs we also conduct studies in our partner hospitals. Our well-developed network of research physicians and strong connections with medical centres in most therapeutic areas provide access to diverse groups of patients and make conducting any complex trial a reality.
For example, we at Ascent have recent successful experience in performing BE trials in oncology populations for brain and breast cancers.

Here's a quick overview of our recent BE studies and capabilities we provide our partners with

BE recent

We understand that importance of qualification and training is paramount for clinical trials to ensure every procedure is conducted correctly. All our staff involved in a study is frequently trained according to our BE SOPs and is proficient in monitoring and managing study as well as documenting all the performed activities. Medical staff also receives appropriate training in drug storage, drug administration, blood draws, PK sample processing, PK sample storage & shipment.

 

Here's what our BioEquivalence package consists of

  • Full package of study documents
    Including Study Protocol, Investigators Brochure, Case Report Forms (CRFs), Informed Consent Forms (ICF)
  • Regulatory affairs.
    We provide assistance with clinical study submission to the Regulatory Authorities (HA/EC approvals, import/export of study medication, etc) in Russia & Georgia
  • Project Management
  • Clinical Conduct
    Including Healthy volunteers recruitment and screening, drug administration, laboratory tests, blood sampling, hospitalization, emergency care
  • Monitoring
  • Data management & Biostatistics
  • Medical writing and scientific review

We perform Quality Assurance and Quality Check at every stage of the study according to our SOPs and provide you with prompt and direct feedback.
 

 We'll make everything possible for your product to hit the market according to your timelines!