Ensuring the integrity of safety data and reporting adverse drug reactions (ADRs) by researchers in randomized multicenter clinical trials is a cornerstone of pharmacovigilance, according to the scientific journal “Scientific Research Journal”. Tinatin, who conducted this study, emphasized that critical issues such as data integrity and proper reporting must be addressed first.
Tinatin Gogrichiani, MD, is a Senior Clinical Research Associate with the top Global Clinical Research Organization, ICON Plc . Additionally, she is a member of the Washington, DC-based Association of Clinical Research Professionals and Center for Health and Human Rights Research (HC&HRRC).
Tinatin successfully participates and oversees clinical trials in Oncology, Rare diseases, Genetic Disorders, Neurology, Systemic Metabolic Disorders. As a Senior Clinical Research Associate and Monitor her role is crucial for managing, monitoring trial processes to ensure research validity , protect data integrity and enhance the quality of the research outcomes. In addition, she is actively involved in public work. Tinatin has taken part in monitoring the activities of the Parliamentary Committee on Health initiated by the Foundation for Innovation and Development and has made significant contributions to the implementation of impactful USAID-funded healthcare projects in Georgia as the Research Team Leader at the Center for Health and Human Rights Research (HC&HRRC).
Tinatin Gogrichiani, thanks to successful execution of large-scale clinical trials, took the position of head of the Clinical Research department at JSC Jerarsi Clinic, one of the leading multidisciplinary therapeutic institutions in Georgia, at the age of 25. She contributed to the development of an efficient organizational structure of the clinic that focused on providing patients with innovative treatments and improved the quality of research, with strict respect for human rights and safety.
“The Comprehensive Standard Operating Procedure (SOP), developed by me, fosters consistency in the clinic’s operations and addresses common challenges in clinical research and helps clinical trial team systematically manage research data and report adverse events, ensuring patient safety and adherence to regulatory and scientific requirements. The standards serve to harmonize international and local regulations to integrate them into medical institutions processes enhancing study deliverables, outcomes and filling the process gaps and preventing issues like improper documentation and misunderstandings in work procedures. These factors often lead to noncompliance during audits and inspections, both in Georgia and globally. So The main goal is to improve the efficiency and reliability of clinical trials, setting a higher standard for operational excellence in the field.” Tinatin said. Data collection and optimization play a key role in the activities of large companies, especially those involved in the healthcare sector. Tinatin’s developments have helped medical organizations in Georgia to improve their data collection processes. This has allowed for increased patient engagement, a deeper understanding of the safety profile of studied drugs, and ensured the reliability of research information.
Under the leadership of Tinatin Gogrichiani, the clinic has achieved remarkable success in implementing a series of international and other.
Her contributions benefit not only the institutions she works with but also the broader healthcare system and the Georgian economy. By ensuring compliance with rigorous research standards and providing access to cutting-edge treatment options for more patients, she contributes to enhancing the quality of care. In addition, her contribution has supported to strengthening Georgia’s position in the global pharmaceutical industry by ensuring a high level of reliability of the data obtained. This evidenced by several successful inspections and audits performed by both local authorities and foreign audit companies.
“Throughout my work I am contributing to the delivery of medicines with transformational impact for cancer, rare diseases, and biosimilars for more affordable treatment options for patients”
Since 2021 has moved on a global scale and joined World`s leading Healthcare Intelligence CRO (clinical research organization) has been working with several leading global American and European pharmaceutical corporations , biotechnology companies – participating in the development of best-in-class small molecules and cell therapies in oncology and immunology. Focusing on high unmet medical needs and shape the future of healthcare currently working on the such important research as: Gastric Cancer, Phase 1 study in patients with locally advanced or metastatic tumors, CDKL5 deficiency disorder , Lupus erythematosus , Rheumatoid Arthritis.
In 2024 year, the Senior Clinical research monitor was appointed to the position of leading clinical researcher at the International Research Organization for gastric oncology, where she led a team in Turkey. Her experience and achievements contributed to her appointment as a global clinical specialist within the immunology project, including remote monitoring of the quality of research documentation, and coordination of investigational drugs related processes in the USA, Poland, Taiwan, South Korea, India.
“Throughout my work i am contributing to the delivery of medicines with transformational impact for cancer, rare diseases and biosimilars for more affordable treatment options for patients , by close oversight and monitoring of research processes , ensuring the validity of research data , confirming patients eligibility for the trials , assessing medication intake impacts , treatment results , dynamics of disease development , proper reporting of side effects while ensuring patients safety , rights and data integrity is protected” noted Tinatin.
The most significant scientific achievements of Tinatin Gogrichiani MD led to the collection of primary and secondary data on new therapeutic agents. These data contribute to the development of innovative drugs for the treatment of oncological and rare diseases with significant clinical implications. The types of drugs that were developed include biosimilars, cell therapies, cytokines, interleukins, interferons, monoclonal antibodies, and immune checkpoint inhibitors. These breakthroughs significantly improve the prospects for fighting cancer and other diseases, providing patients with a stronger hope for recovery.
In addition to career and social achievements, Tinatin pays great attention to public initiatives and continuous professional development. She participated in three international conferences of researchers held in Spain. The conferences were devoted to topical issues of medical science, such as gastric cancer, lupus erythematosus, and CDKL5 deficiency syndrome.
“By facilitating timely and precise monitoring of clinical trials, we play a crucial role in enhancing the overall success of the drug development process and securing FDA and EMA approvals. We mitigate risks that could lead to deviation from all applicable regulatory and scientific requirements in order to maximize our success in developing and delivering best-in-class medicines and aim to make transformational impact happen faster,” emphasized Gogrichiani.
Tinatin Gogrichiani is an active member of the Center for Health and Human Rights Research (HC&HRRC) and has been an integral part of the team since 2022. She has served as the head of the research group on several key projects, including “To Elaborate a Homecare Model for Georgia” (2022): Financed by Caritas Czech Republic in Georgia, the “Coalition for Independent Living” USAID-funded project, and “Evaluation of Integrated Care Services in Georgia for Psychoactive Substance Users and Their Family Members to Advocate for Best Practices” (2024): Funded by the Open Society Georgian Foundation (OSGF) and the European Union (EU).
As a result of the research advisory documents were established about the necessary regulations, funding, and support systems needed to implement and sustain effective homecare services in Georgia, emphasize the importance of patient education and self-management, empowering patients and caregivers with the knowledge and skills to manage health conditions effectively and explored how technology, such as telehealth and remote monitoring, can be integrated into homecare, enhancing service delivery and patient monitoring.
Tinatin’s outstanding skills, innovative approach and dedication have greatly benefited the organization and contributed to the advancement of healthcare and research in Georgia, according to Nino Mirzikashvili, the Director of HC&HRRC.
Tinatin has shared her aspirations for improving the clinical research data collection process and implementing a comprehensive standard operating procedure nationally in several medical institutions, setting a higher standard for operational excellence in the field and providing quality research data having impact in drug development globally. These initiatives aim to make sure innovations reach patients who need them most and optimize the work of researchers in key areas of medicine.
