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