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Year 2018 ( Hide...)

December’18 
  • Final statistical analysis completed and report prepared in Phase II study on the efficacy and safety of oral combination therapy with patients with chronic hepatitis C.
  • Final statistical analysis completed and report prepared in long-term observational study in patients with breast cancer.
  • Ethical approval obtained, Investigator Meeting conducted and First Patient First Visit achieved in big observational study in patients with acute non-specific low back pain.
November’18 
  • The second interim statistical analysis was completed and interim report prepared for Phase II study on the efficacy and safety of oral combination therapy with patients with chronic hepatitis C.
  • On November 13-14, 2018 ALMEDIS took part in the international forum “Clinical research in Russia” by Adam Smith. ALMEDIS presented its practical experience in supporting of investigator initiated trials in Russia.
  • Last patient last visit occurred in Phase II study on the efficacy and safety of oral combination therapy with patients with chronic hepatitis C.
  • Project for Russian translation and cultural adaptation of questionnaire for patients with oncohematological diseases started.
  • Database was closed in long-term observational study in patients with breast cancer.
  • Statistical analysis completed and report prepared in long-term observational study in patients with prostate cancer.
October’18 
  • On October 10, 2018, ALMEDIS, as a member of the MedDRA translation working group, took part in the International Conference “Pharmacovigilance: Challenges and Opportunities”, organized by the Russian Federal Service for Supervision Healthcare and Social Development (Roszdravnadzor) and the AIPM.
  • On October 18-19, 2018, the Executive Manager of ALMEDIS, as a member of the ACTO board, participated in a seminar for local ethical committees members "Actual issues of clinical research ethical expertise", organized by the Yevdokimov Moscow State Medical University, Pfizer and the Association of Clinical Research Organizations (ACTO).
  • Statistical analysis of observational studies in patients with prostate cancer has been completed.
  • The last patient last visit (for Russian Federation) achieved in the international multicenter Phase III clinical trial in patients with acute coronary syndrome receiving antiplatelet therapy after pharmacological thrombolysis (TREAT), initiated by the researcher. In Russia, 700 patients were included in the study.
  • The next regular cycle of webinars for physicians on good clinical practice, conducted by ALMEDIS in collaboration with Institute of Laboratory Medicine (https://dpo-ilm.ru/info/faculties/29/cathedra/49/information), started. After the webinar cycle and final testing participants received state training certificates.
  • The Association of Clinical Research Organizations (ACTO, http://acto-russia.org) published the next issue of the Newsletter on the results of the first half of 2018: http://acto-russia.org/files/bulletin_17.pdf
September’18 
  • ALMEDIS applied to the Federal Institute of Industrial Property (FIPS) an application for a patent for medical device.
  • ALMEDIS will participate in the Adam Smith international forum “Clinical trials in Russia” on November 13-14, 2018. We invite you to visit our presentation on IIT - investigator initiated trials. We plan to talk about our practical experience in supporting such research in Russia.
August’18 
  • The database for a long-term observational study in patients with prostate cancer was locked.
  • The first patient's first visit was conducted in a study evaluating the effect of the biologically active supplement (probiotic Lactobacillus reuteri) on formation of intestinal microbiota in children born by cesarean section.
July’18 
  • Interim analysis in a long-term observational study in patients with breast cancer has been finalized.
  • ALMEDIS joined the working group on the Russian translation of MedDRA coding dictionary. Having broad practical experience in medical coding in clinical trials data management, we hope to add value to this work and facilitate the introduction of standard coding processes into the routine data management practice of pharmacovigilance and clinical trials in Russia.
June’18 
  • ALMEDIS received the approval of the Ministry of Health for conduction in Russia of the international clinical trial, phase IV, for prevention of recurrent thromboembolic complications during pregnancy (Highlow). This study is initiated by Academic Medical Center, the Netherlands, and conducted in France, Ireland, Belgium, Norway, USA and Canada. The information about the study can be found on its webpage.
  • Clinical study report has been prepared and approved by the sponsor for the international multicentre clinical study of bioequivalence in patients with advanced prostate cancer.
  • ALMEDIS received the approval of the Interdisciplinary Ethics Committee for conduction of a study evaluating the effect of the biologically active supplement (probiotic Lactobacillus reuteri) on formation of intestinal microbiota in children born by cesarean section.
  • ALMEDIS prepared the article based on results of a clinical study of the efficacy, safety and tolerability of the drug for colon cleansing before colonoscopy.
May’18 
  • ALMEDIS in collaboration with the Institute of Laboratory Medicine announced the launch of the Clinical Research Department for conduction of trainings in clinical researches.
  • ALMEDIS participated in the training “MedDRA: Safety Data Analysis and SMQs”, organized by the ICH MedDRA Maintenance and Support Services Organization (MSSO). MedDRA is international vocabulary of standardised medical terminology used in the registration, documentation and safety monitoring of medical products. ALMEDIS is subscriber of MedDRA since 2007. We use the dictionary for Data Management and Pharmacovigilance services.
  • ALMEDIS participated in the Ennov User Group Meeting, which took place in New Orleans, USA. Ennov provides software solutions for the pharmaceutical industry in pharmacovigilance, regulatory, quality management and clinical trials management. For more than 10 years, ALMEDIS has been using the clinical trials data management system developed by Ennov.
  • ALMEDIS has prepared the concept of myelofibrosis patients register.
  • ALMEDIS prepared interim clinical study report based on the results of the analysis in Phase II clinical trial evaluating the efficacy and safety of all-oral combined therapy in patients with chronic hepatitis C.
April’18 
  • ACTO (Association of Clinical Trials Organizations, http://acto-russia.org/en/) has issued ACTO Newsletter No. 16 providing an analysis of trends and dynamics of the Russian clinical trials market in 2017
  • ALMEDIS has prepared data for an interim analysis in Phase II clinical trial evaluating the efficacy and safety of all-oral combined therapy in patients with chronic hepatitis C
  • On May 23rd, 2018, ALMEDIS will participate in the 3rd Clinical Operations Strategy Meeting Europe, which will take place in Munich, Germany https://proventainternational.com/clinical-operation-eu-2018/
March’18 
  • Interim analysis of an international multicenter Phase III clinical trial in patients with acute coronary syndrome receiving antiplatelet therapy after pharmacological thrombolysis (TREAT) was reported by the study sponsor in Orlando, USA, at ACC.18, 67th Annual scientific session & expo (https://accscientificsession.acc.org/Plan-Your-Program/Late-Breakers). ALMEDIS is proud of the patient recruitment in the Russian Federation (700 patients), and thanks all the investigators for their excellent work! 
  • Patients recruitment is completed in the Phase II clinical trial evaluating the efficacy and safety of all-oral combined therapy in patients with chronic hepatitis C
  • ALMEDIS closed the database of the international multicentre clinical study of bioequivalence in patients with advanced prostate cancer and started data analysis
February’18 
  • First patient was enrolled in a non-interventional study in patients with hemophilia A. 
  • ALMEDIS completed additional analysis of data for phase 3 clinical trial in patients with CML. The clinical study report and datasets prepared in compliance with all international standards are finalized and approved by the sponsor. 
  • The textbook "Management of Clinical Research" written with participation of ALMEDIS employees was published. This book describes the methodology for developing and marketing medicines. Detailed information can be obtained on the website of the publisher LLC "Publishing House OKI": http://www.izdat-oki.ru/journals/item/upravlenie-klinicheskimi-issledovaniyami
  • ALMEDIS representatives took part in ACTO business breakfast, held jointly with the Executive Secretary of the Independent Interdisciplinary Ethics Committee, the Chairman of the Inter-College Ethics Committee, the Vice-Rector of the MGMS named afetr U. A.Evdokimov E.A. Volskaya. The meeting was devoted to practical questions and issues arising during the ethical review of clinical trials. 
January’18 
  • Clinical trial application for Phase IV clinical study in prevention of trombotic complications of pregnancy has been submitted to the Ministry of Health of the Russian Federation.
  • Statistical report has been prepared for a sponsor in a non-interventional study, involving more than 12 000 patients with osteoarthritis and lower back pain.

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