OCT presence in CEE
OCT Offices
Organization Chart
OCT infrastructure in Russia Samara Novosibirsk Rostov-on-Don Yekaterinburg Saint-Petersburg  Moscow Nizhniy Novgorod
<ul><li>OCT Staff  about 90 people   in total </li></ul><ul><li>1/2 of the staff are in clinical department </li></ul><ul>...
Clinical Experience
Clinical Experience Therapeutic Area Indication Phase Status 2008 Ophthalmology ARMD Phase I Finished Neurology Arterial A...
Clinical Experience Therapeutic Area Indication Phase Status 2010 Oncology  Advanced cancer /solid tumor Phase I-IIa Ongoi...
Clinical Experience Therapeutic Area Indication Phase Status 2010 Gastroenterology Liver disorder P ost-marketing Finished...
Clinical Experience Therapeutic Area Indication Phase Status 2011 Poisoning Sedation of benzodiazines Phase III Medical wr...
Clinical Experience Therapeutic Area Indication Phase Status 2011 Oncology Locally Advanced Pancreatic Adenocarcinoma  Pha...
Clinical Experience Therapeutic Area Indication Phase Status 2011 Gastroenterology Spasms, colonoscopy Phase III  Start-up...
<ul><li>Consulting </li></ul><ul><li>Medical writing </li></ul><ul><li>Feasibility </li></ul><ul><li>Project management </...
Clinical trials HOW WE DO IT
<ul><li>Consulting and Medical Writing </li></ul><ul><li>Study design in country-specific environment </li></ul><ul><li>Sa...
<ul><li>Primary client contact and every - day communication </li></ul><ul><li>Project planning </li></ul><ul><li>Ensuring...
<ul><li>Medical Doctors on staff </li></ul><ul><li>Monitors have at least 2 years of experience </li></ul><ul><li>Accumula...
<ul><li>Translation of essential study documents required for submission </li></ul><ul><li>Adjustment of informed consent ...
<ul><li>Average time from application submission </li></ul><ul><li>to final study approval (months) </li></ul>Regulatory a...
<ul><li>Import of drugs, laboratory kits, other supplies </li></ul><ul><li>Export of biologic samples </li></ul><ul><li>Cu...
<ul><li>EDC System development (CDISC CDASH compliance)  </li></ul><ul><li>Double data entry (for paper CRF) </li></ul><ul...
Overall Indexed Clinical Trial Costs Source: A.T. Kearny analysis
Contacts <ul><li>Russia: </li></ul><ul><ul><li>HEADQUARTERS :  8/2 Bolshaya Moskovskaya Str., Suite 4-1 St.Petersburg, 191...
 
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OCT_clinical trials in Russia and CEE

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Headquartered in St-Petersburg, Russia, OCT is a full-service contract research organization (CRO) providing high-quality services in clinical trials conduct in Central and Eastern Europe (CEE).
Since 2005 OCT have opened several branch offices in CEE and grown to its current size of 90 people. Our qualified clinical team includes medical doctors and R&D professionals in Russia, Ukraine, Bulgaria, Belarus, Latvia, Lithuania, Estonia, Poland and Czech Republic.
OCT have extensive experience in a wide range of therapeutic areas handling both drug and device trials.
We are dedicated to provide high quality yet personal service.

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OCT_clinical trials in Russia and CEE

  1. 2. OCT presence in CEE
  2. 3. OCT Offices
  3. 4. Organization Chart
  4. 5. OCT infrastructure in Russia Samara Novosibirsk Rostov-on-Don Yekaterinburg Saint-Petersburg Moscow Nizhniy Novgorod
  5. 6. <ul><li>OCT Staff about 90 people in total </li></ul><ul><li>1/2 of the staff are in clinical department </li></ul><ul><li>Home- based CRAs and freelance CRAs </li></ul>Clinical Staff
  6. 7. Clinical Experience
  7. 8. Clinical Experience Therapeutic Area Indication Phase Status 2008 Ophthalmology ARMD Phase I Finished Neurology Arterial Aneurysm Phase III Finished Urology Erectile Dysfunction Phase III Finished Endocrinology Diabetes Mellitus Phase II Finished Oncology Ovarian Cancer Phase III Ongoing Oncology Breast Cancer Phase III Ongoing Oncology Cancer Phase I Finished 2009 Gastroenterology H. Pylori Phase III Finished Endocrinology Hypothyriosis Post-marketing Finished Gastroenterology Liver diseases Post-marketing Finished Endocrinology Diabetes Mellitus Phase II Finished Oncology Breast cancer Phase III Ongoing Cardiology Hypertension+LVH Phase IV Finished Hepatology Hepatic cirrhosis Phase III Finished
  8. 9. Clinical Experience Therapeutic Area Indication Phase Status 2010 Oncology Advanced cancer /solid tumor Phase I-IIa Ongoing Surgery Pain Phase II Ongoing Oncology Metastatic breast cancer Phase II Ongoing   (patients enrollment) Cardiology Hypertension Phase II On hold Neurosurgery Aneurism rupture Phase III Finished CNS Bioequivalence BE/PK Medical writing completed Endocrinology Autoimmune thyroiditis Phase IV Finished Rheumatology Gout Phase II I Start-up Oncology Cancer Pre-clinical Finished Neurology Multiple Sclerosis Post-marketing Ongoing Pediatrics Gastroenterology, Neonatology Flatulence, intestinal colics P ost-marketing Finished
  9. 10. Clinical Experience Therapeutic Area Indication Phase Status 2010 Gastroenterology Liver disorder P ost-marketing Finished Traumatology, orthopedics Major joints surgery Phase III Finished Pulmonology, Pediatrics Bronchitis, pneumonia, asthma P ost-marketing, Finished Otorinolaringology Rhinitis Post-marketing Finished Respiratory Sore throat associated with URTI Pilot study Finished Oncology Ovarian cancer Phase III Ongoing (patients enrollment) Oncology Metastatic breast cancer Phase II Ongoing Oncology Endometrial cancer Phase II Start-up   Surgery Colorectal anastomosis Pilot (device) Finished Pediatrics Acute bronchitis Phase IV Start-up Systemic diseases Mastocytosis Phase III Start-up Pediatric/gastroenterology Intestinal colics Phase II Ongoing Infectious diseases HDV Phase I Data management
  10. 11. Clinical Experience Therapeutic Area Indication Phase Status 2011 Poisoning Sedation of benzodiazines Phase III Medical writing completed CNS Alzheimer disease Phase I Medical writing completed Oncology Multiple myeloma Phase III Start-up CNS Multiple sclerosis Phase I Start-up Oncology Breast Cancer Phase I-II Start-up Oncology Cancer Pre-clinical Finished Oncology Cancer Pre-clinical Finished Cardiology Hypertension Phase III Medical writing Psychiatry Alcohol addiction Phase I Start-up Surgery Foot ulcers Phase III On hold Oncology Solid tumors Phase I Start-up CNS Hemispheric ischemic stroke Phase IV Data management
  11. 12. Clinical Experience Therapeutic Area Indication Phase Status 2011 Oncology Locally Advanced Pancreatic Adenocarcinoma Phase II Start-up Internal diseases Chronic fatigue Phase I Start-up Oncology Colorectal cancer Phase III Start-up Internal diseases Healthy volunteers Phase I Start-up Oncology Bladder cancer Phase II b Start-up Respiratory diseases Asthma, COPD Phase III Start-up Oncology Head and neck cancer Phase III Start-up Therapy Arthrosis, Polyarthritis BE Start-up Cardiology Isolated systolic hypertension Phase III Start-up Pediatrics Colitis Phase II Start-up Oncology Advanced solid tumors Phase I b Start-up Therapy Myalgia, arthritis Phase III Start-up Pulmonology Bronchitis, Pneumonia BE Start-up
  12. 13. Clinical Experience Therapeutic Area Indication Phase Status 2011 Gastroenterology Spasms, colonoscopy Phase III Start-up Therapy Central catheter's maintenance Phase II Start-up Surgery Parenteral nutrition Phase III Start-up Rheumatology Rheumatoid arthritis, psoriasis Phase IIb-III Medical writing Oncology Neutropenia in breast cancer Phase I-II Medical writing Neurology Pregnancy registry, multiple sclerosis Post-marketing Start-up Nephrology Anemia in chronic kidney disease Phase IIa-III Medical writing
  13. 14. <ul><li>Consulting </li></ul><ul><li>Medical writing </li></ul><ul><li>Feasibility </li></ul><ul><li>Project management </li></ul><ul><li>Regulatory support </li></ul><ul><li>Clinical monitoring </li></ul><ul><li>CRA training </li></ul>Services provided by OCT <ul><li>Logistics support </li></ul><ul><li>Audits </li></ul><ul><li>Purchase of concomitant medication </li></ul><ul><li>Data management </li></ul><ul><li>Statistics </li></ul><ul><li>Safety Management </li></ul>
  14. 15. Clinical trials HOW WE DO IT
  15. 16. <ul><li>Consulting and Medical Writing </li></ul><ul><li>Study design in country-specific environment </li></ul><ul><li>Sample size calculation </li></ul><ul><li>Development of study essential documents </li></ul><ul><li>Study protocol </li></ul><ul><li>Informed Consent Form </li></ul><ul><li>Investigators’ Brochure </li></ul><ul><li>IMPD review </li></ul><ul><li>Strategic clinical development planning </li></ul>Consulting and Medical Writing
  16. 17. <ul><li>Primary client contact and every - day communication </li></ul><ul><li>Project planning </li></ul><ul><li>Ensuring strict adherence to project timelines, budget, and quality performance in accordance with CFR 21/ICH GCP and local regulations </li></ul><ul><li>Team trainings </li></ul><ul><li>Principal Investigator selection </li></ul><ul><li>Investigators’ Meeting preparation </li></ul>Project Management
  17. 18. <ul><li>Medical Doctors on staff </li></ul><ul><li>Monitors have at least 2 years of experience </li></ul><ul><li>Accumulated experience in all therapeutic areas </li></ul><ul><li>Team trainings </li></ul><ul><li>Second person review of monitoring reports </li></ul><ul><li>Internal audits </li></ul><ul><li>Site selection based on experience </li></ul><ul><li>Co-monitoring </li></ul><ul><li>Project review meetings </li></ul>Assuring quality of monitoring
  18. 19. <ul><li>Translation of essential study documents required for submission </li></ul><ul><li>Adjustment of informed consent forms to country-specific requirements, cultural adaptation </li></ul><ul><li>Collection of documents required for submission from investigators </li></ul><ul><li>Arrangement of local insurance </li></ul>Regulatory support <ul><li>IMPD preparation if required </li></ul><ul><li>Preparation and QC of the submission application </li></ul><ul><li>Submission of the clinical trial application to regulatory authorities and ethics </li></ul><ul><li>Communication with regulatory authorities and ethics if required </li></ul><ul><li>Export / import license </li></ul>
  19. 20. <ul><li>Average time from application submission </li></ul><ul><li>to final study approval (months) </li></ul>Regulatory approval timelines
  20. 21. <ul><li>Import of drugs, laboratory kits, other supplies </li></ul><ul><li>Export of biologic samples </li></ul><ul><li>Customs clearance </li></ul><ul><li>Shipments tracking </li></ul><ul><li>Clinical trial materials distribution to sites </li></ul><ul><li>Collection of biologic samples from sites </li></ul><ul><li>Biosample export to central laboratories </li></ul>Logistics support
  21. 22. <ul><li>EDC System development (CDISC CDASH compliance) </li></ul><ul><li>Double data entry (for paper CRF) </li></ul><ul><li>Clinical trial database creation and maintaining </li></ul><ul><li>Data cleaning and query processing </li></ul><ul><li>Data coding (acc. to MedDRA) </li></ul><ul><li>Clinical data output (CDISC ODM compliance) </li></ul><ul><li>Power analysis and sample size evaluations </li></ul><ul><li>Biostatistical evaluations </li></ul><ul><li>Statistical report writing </li></ul>DM and Biostatistics
  22. 23. Overall Indexed Clinical Trial Costs Source: A.T. Kearny analysis
  23. 24. Contacts <ul><li>Russia: </li></ul><ul><ul><li>HEADQUARTERS : 8/2 Bolshaya Moskovskaya Str., Suite 4-1 St.Petersburg, 191002, Russia </li></ul></ul><ul><ul><li>MOSCOW OFFICE: Gamsonovsky per. 2, building 2, Suite 77-82, Moscow 115191, Russia </li></ul></ul><ul><li>USA BD Office: </li></ul><ul><li>845 Third Avenue, 6th Floor </li></ul><ul><li>New York, NY 10022, US </li></ul><ul><li>Ukraine: </li></ul><ul><li>34 Lesi Ukrainki Str., Suite 219 </li></ul><ul><li>PO box 50, 01601, Kiev, Ukraine </li></ul>Bulgaria: 2A Temenuga, Str., Apt. 20 Slatina district, Sofia, 1574, Bulgaria The Baltic States: Bauskas str. 33-4 Riga, LV-1004, Latvia Belarus: Severny per. 13/2, Suite 3 Minsk, 220036, Belarus

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