OCT presence in CEEOCT presence in CEE
OCT OfficesOCT Offices
Organization ChartOrganization Chart
OCT infrastructure in RussiaOCT infrastructure in Russia
SamaraSamaraSamaraSamara
NovosibirskNovosibirskNovosibirskNovosibirskRostov-on-DonRostov-on-DonRostov-on-DonRostov-on-Don
YekaterinburgYekaterinburgYekaterinburgYekaterinburg
Saint-Petersburg Saint-Petersburg Saint-Petersburg Saint-Petersburg
MoscowMoscow MoscowMoscowNizhniy NovgorodNizhniy NovgorodNizhniy NovgorodNizhniy Novgorod
• OCT Staff about 90 people in total
• 1/2 of the staff are in clinical department
• Home- based CRAs and freelance CRAs
Clinical StaffClinical Staff
Clinical ExperienceClinical Experience
Therapeutic Area Indication Phase Status
2008Ophthalmology ARMD Phase I FinishedNeurology Arterial Aneurysm Phase III FinishedUrology Erectile Dysfunction Phase III FinishedEndocrinology Diabetes Mellitus Phase II FinishedOncology Ovarian Cancer Phase III OngoingOncology Breast Cancer Phase III OngoingOncology Cancer Phase I Finished
2009Gastroenterology H. Pylori Phase III FinishedEndocrinology Hypothyriosis Post-marketing FinishedGastroenterology Liver diseases Post-marketing FinishedEndocrinology Diabetes Mellitus Phase II FinishedOncology Breast cancer Phase III OngoingCardiology Hypertension+LVH Phase IV FinishedHepatology Hepatic cirrhosis Phase III Finished
Clinical ExperienceClinical Experience
Clinical ExperienceClinical ExperienceTherapeutic Area Indication Phase Status
2010Oncology 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 holdNeurosurgery Aneurism rupture Phase III Finished
CNS Bioequivalence BE/PKMedical writing completed
Endocrinology Autoimmune thyroiditis Phase IV FinishedRheumatology Gout Phase III Start-up
Oncology Cancer Pre-clinical Finished
Neurology Multiple Sclerosis Post-marketing Ongoing
Pediatrics Gastroenterology, Neonatology
Flatulence, intestinal colics Post-marketing Finished
Clinical ExperienceClinical ExperienceTherapeutic Area Indication Phase Status2010
Gastroenterology Liver disorder Post-marketing
Finished
Traumatology, orthopedics Major joints surgery Phase III Finished
Pulmonology, Pediatrics Bronchitis, pneumonia, asthma Post-marketing,
Finished
Otorinolaringology Rhinitis Post-marketing
Finished
Respiratory Sore throat associated with URTI Pilot study Finished
Oncology Ovarian cancer Phase IIIOngoing (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
Clinical ExperienceClinical ExperienceTherapeutic 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
Clinical ExperienceClinical ExperienceTherapeutic 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
Clinical ExperienceClinical ExperienceTherapeutic 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
• Consulting
• Medical writing
• Feasibility
• Project management
• Regulatory support
• Clinical monitoring
• CRA training
Services provided by OCTServices provided by OCT
• Logistics support
• Audits
• Purchase of concomitant
medication
• Data management
• Statistics
• Safety Management
Clinical trials
HOW WE DO IT
• Consulting and Medical Writing
• Study design in country-specific environment
• Sample size calculation
• Development of study essential documents
• Study protocol
• Informed Consent Form
• Investigators’ Brochure
• IMPD review
• Strategic clinical development planning
Consulting and Medical WritingConsulting and Medical Writing
• Primary client contact and every-day communication
• Project planning
• Ensuring strict adherence to project timelines, budget, and quality performance in accordance with CFR 21/ICH GCP and local regulations
• Team trainings
• Principal Investigator selection
• Investigators’ Meeting preparation
Project ManagementProject Management
• Medical Doctors on staff
• Monitors have at least 2 years of experience
• Accumulated experience in all therapeutic areas
• Team trainings
• Second person review of monitoring reports
• Internal audits
• Site selection based on experience
• Co-monitoring
• Project review meetings
Assuring quality of monitoringAssuring quality of monitoring
• Translation of essential study documents required for submission
• Adjustment of informed consent forms to country-specific requirements, cultural adaptation
• Collection of documents required for submissionfrom investigators
• Arrangement of local insurance
Regulatory supportRegulatory support
• IMPD preparationif required
• Preparation and QCof the submission application
• Submission of the clinical trial application to regulatory authorities and ethics
• Communicationwith regulatory authorities and ethics if required
• Export / import license
Average time from application submissionto final study approval (months)
Regulatory approval timelinesRegulatory approval timelines
• Import of drugs, laboratory kits, other supplies
• Export of biologic samples
• Customs clearance
• Shipments tracking
• Clinical trial materials distribution to sites
• Collection of biologic samples from sites
• Biosample export to central laboratories
Logistics supportLogistics support
• EDC System development (CDISC CDASH compliance)
• Double data entry (for paper CRF)
• Clinical trial database creation and maintaining
• Data cleaning and query processing
• Data coding (acc. to MedDRA)
• Clinical data output (CDISC ODM compliance)
• Power analysis and sample size evaluations
• Biostatistical evaluations
• Statistical report writing
DM and BiostatisticsDM and Biostatistics
Overall Indexed Clinical Trial CostsOverall Indexed Clinical Trial Costs
Source: A.T. Kearny analysis
ContactsContacts
Russia:HEADQUARTERS:
8/2 Bolshaya Moskovskaya Str., Suite 4-1St.Petersburg, 191002, Russia
MOSCOW OFFICE:
Gamsonovsky per. 2, building 2, Suite 77-82, Moscow 115191, Russia
USA BD Office:845 Third Avenue, 6th FloorNew York, NY 10022, US
Ukraine: 34 Lesi Ukrainki Str., Suite 219 PO box 50, 01601, Kiev, Ukraine
Bulgaria: 2A Temenuga, Str., Apt. 20Slatina district, Sofia, 1574, Bulgaria
The Baltic States: Bauskas str. 33-4Riga, LV-1004, Latvia
Belarus:Severny per. 13/2, Suite 3Minsk, 220036, Belarus