We collaborate with the modern laboratory of 2 and 3 biosafety level. Biosafety Zone Level 2 (BSL-2) includes the following laboratories: General Bacteriology, Virology, Serology, Molecular Epidemiology / Genome, Cell Culture, Parasitology and Endemology. All clinical and laboratory diagnostic and scientific research, requiring the use of the BSL-3 laboratory, is carried out at the Lugar Center. This Center is equipped with New Generation Sequence equipment, which provides a unique opportunity for genome research as well. The Lugar Center is the only BSL-3 laboratory throughout the Caucasus and Central Asia.
Using about 10 years of the clinical trial experience of our employees, Axis CRO provides the knowledge and resources to conduct comprehensive protocol, country and site feasibility that deliver accurate and more predictable study plans. Our team’s detailed understanding of clinical trial protocol design, regional regulatory requirements, standards of care and patient recruitment and retention strategies provides unparalleled foresight into potential challenges for clinical trial execution that delivers as planned. Before committing to a project, we follow a detailed feasibility process, which includes strategic site selection, taking into account the priorities of our clients.
Axis can provide you with all the local regulatory expertise to ensure the smoothest possible start of your study. We are local experts of country specific regulations/requirements. We specialize in supporting small, virtual start-ups, and innovative drug development companies, we give you with regulatory guidance and expertise as well as with the experience to accelerate your life-changing new therapies through to regulatory approval.
As the key interface between regulatory authorities and the project team, we work closely with you to anticipate requirements early utilizing strategic advice meetings and best practices from our experience.
Our local team executes start-up strategy through coordination of regulatory and ethics submissions, ensuring ICH GCP compliance through provision of essential documents, negotiation and execution of site contracts.
- Organization of legal representation
- Translation of all study-related documents into local language
- Ethics Committee submissions
- Submissions to regulatory body
- Organization of study supply logistics, including obtaining import and export licenses
- Organizing local insurance coverage
Axis CRO provides a team of experts, who are medical doctors, certified in different specialties, that identifies and selects the right sites for your study, with respect to therapeutic area experience.
Our process for identifying, qualifying and selecting clinical trial sites starts during feasibility and continues into the start of a program. Axis CRO guides our clients through the following processes, ensuring that each trial gets off to the strongest possible start. We collaborate with the most experienced Principal Investigators and sites in the country, who ensure high enrollment rate in the study. We follow a qualification and selection process that can be customized for each client, for each study.
For a clinical trial to proceed smoothly, meet its milestones on schedule and produce the best results, it is vital that both the research sites conducting the study and the participating patients remain thoroughly involved and engaged, from the study startup to its conclusion. Axis CRO has assembled team of local industry-leading experts, who are focused specifically on enrolling, engaging, and retaining the right participants for your study. For the site engagement our team developing authentic long-term relationships with principal investigators and their site staff.
- Site identification and selection of investigators
- Site and investigator contracts, budget negotiation
Axis Clinical Research Associates are locally-based, highly skilled professionals with Medical Doctor degrees, experienced in monitoring clinical trials according to Good Clinical Practice (GCP) standards. They are up to date with leading technologies including EDC, CTMS, eTMF solutions. Because of their professional background, our CRAs have on-going professional relationships with the leading investigators and their colleagues based at their sites.
- Site, qualification, selection, activation and closeout
- Regulatory document review and collection
- Site training
- Interim site monitoring
- Investigational Drug accountability
- Data query resolution
- Data lock in collaboration with biometrics
- Study closure
We provide high-quality translation service for all study-related documents into local language in the tight timelines. We also provide notary certification cervices for the translated documents, as MoH requirement is to submit notary certified Georgian translated documents.
We will help you to efficiently manage clinical supply logistics to ensure clinical trial supplies, ancillary supplies, and central lab services are delivered in time and within budget.