Cromos Pharma
Dr. Mikhail Kamkha has a diverse work experience in the medical and clinical research field. Dr. Mikhail started their career as a hospital attendant and nurse in surgical departments, where they gained hands-on experience in patient care and surgical procedures. Dr. Mikhail then worked as a Medical Consultant at Forte and as a Clinical Research Specialist at Crocus Medical B.V.
In 2013, Dr. Kamkha joined Biorasi, where they held various roles including Associate, Clinical; Lead, Clinical Monitoring; Quality Assurance Specialist; Manager, Clinical Optimization; and Clinical Team Manager. In these roles, they demonstrated expertise in managing clinical aspects of studies, optimizing trial planning and execution, conducting site visits, and ensuring compliance with regulations and guidelines.
Currently, Dr. Kamkha serves as the Head of Study Start-Up and previously held the position of Head of QA at Cromos Pharma since December 2021. In these positions, they are responsible for overseeing quality assurance processes and study start-up activities.
Overall, Dr. Mikhail Kamkha has a well-rounded work experience in clinical research, quality assurance, study start-up, clinical monitoring, and patient care.
Dr. Mikhail Kamkha, MD, MRQA completed their education at the First Moscow State Medical University named after I.M. Sechenov. Dr. Mikhail earned a Doctor of Medicine (MD) degree from 2002 to 2010 in the field of Medical Doctor. Following their medical degree, they pursued further training in the Department of Surgery № 2 of MMA I.M. Sechenov in municipal clinical hospital 61, where they completed a General Surgery Residency Program from 2010 to 2011.
In addition to their educational qualifications, Dr. Kamkha has obtained several certifications. These include certifications in various aspects of clinical research such as collecting and reporting adverse events, data management, informed consent, the principles of Good Clinical Practice (GCP), conducting GCP inspections/audits, and good laboratory practices. Dr. Mikhail has also received training in clinical research and project management in Europe, bioequivalence studies in Russia, and monitoring of clinical trials.
Furthermore, Dr. Kamkha has attended workshops and training sessions on pharmacovigilance, drug safety, and the responsibilities of a Qualified Person responsible for Pharmacovigilance (QPPV). Dr. Mikhail has also completed a workshop on GCP.
Overall, Dr. Mikhail Kamkha has a strong educational background in medicine and has obtained additional certifications and training to enhance their expertise in clinical research and related areas.
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Cromos Pharma
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Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management. Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye resulting in rapid patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials. We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data. Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.