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  September 29, 2016
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OCT Group

5 Kovensky lane
Saint-Petersburg, 191014
Russia

Phone: +7 (812) 449-86-34
Fax: +7 (812) 449-86-35
E-Mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Description:

Center Overview

OCT is your clinical trial experts in Russia, Europe and the US.

OCT is a contract research organization (CRO) offering full-scale clinical trial support for Phases I-IV to pharmaceutical, biotech, and nutraceutical companies interested in conducting clinical trials in Eastern and Central Europe and the US. The company has offices in Russia, Ukraine, Baltic States, Bulgaria, Belarus, Georgia, Germany, US. OCT delivers rapid patient recruitment, ensures quick and efficient addressing of regulatory issues and provides solid logistical support to reduce trial set-up time. Our hands-on region-specific experience across the broad range of clinical trial management activities is your guarantee to a successful clinical trial.

OCT collaborates with highly qualified investigators (sites) with prior experience in conducting GCP-compliant clinical trials across various therapeutic areas. We ensure the integrity of your clinical trial by selecting investigators experienced in conducting industry-sponsored GCP compliant clinical trials and providing them with the support of our monitors they need at each stage of a study. Our local monitors are medical doctors (MD) experienced in conducting industry-driven clinical trials and building reciprocally appreciative professional relationships with the investigators to make your trial flow as smooth as possible. Our clients benefit from access to a large pool of mostly drug-naive patients, rapid patient enrollment and high level of patient compliance due to centralized healthcare systems, and competitive costs. OCT’s established regulatory interface with the authorities allows expediting review times. The net effect of these factors for the client is both cost-saving and the reduction of time necessary to complete the trial. Besides clinical studies of drug candidates for biotech and pharmaceutical companies, OCT conducts clinical studies of nutritional products. OCT is the first CRO conducting such trials in Russia in compliance with ICH-GCP.

We are committed to providing flexible service options for our clients, who may choose to outsource to us only a part of management of the clinical trials: regulatory submissions, logistical support, medical GCP-compliant monitoring, medical writing, QA/Co-monitoring. Importantly, we can rapidly join a study at any stage to provide fast patient recruitment when the study falls behind schedule.

Clinical Trial Services

Medical monitoring and project management

  • Selecting research centers, pre-study site assessment
  • Assistance in coordinating activities of the researchers
  • Monitoring study progress
  • Source document reviewing and verification
  • Confirming patient eligibility
  • Tracking patient compliance
  • Managing study supply inventories
  • Reporting adverse events
  • Monitoring regulatory compliance
  • Drug registration in Russia

Staffing

  • CRAs, Lead CRAs, Project Managers, Regulatory Officers, Logistics Coordinators, and CTAs

Regulatory support

Regulatory support for clinical trials in Russia and Europe:

  • Established regulatory interface with the authorities
  • Submission to health care authorities, central and local ethics committees for approvals to carry out clinical trials
  • Regulatory consultation
  • Obtaining permissions to destroy remaining investigational product
  • Certification of imported equipment
  • Translation services
  • Drug registration in Russia

Finance Management

  • Financial project planning
  • Grant payments to the medical researchers
  • Payments to the clinic administration
  • Designing and managing contracts with clinic administration and investigators
  • All customs payments during clinical trials
  • Supporting the finance budget for clinical research
  • Negotiating purchase of additional equipment, accompanying materials, and various supplies
  • Any other finance support

Insurance policies

  • Obtaining insurance for patients and investigators’ liability for participating in studies
  • Obtaining insurance for the medications under research during their transportation to the country of research
  • Obtaining insurance for the medications during their storage in clinics or at a centralized warehouse

Logistical Support

  • Obtaining import and export licenses for investigational product and biologic specimens
  • Preparation of documents for customs clearance
  • Customs clearance of the cargoes
  • Allocation and transportation of the cargoes
  • Tracking of the cargo during delivery
  • Providing the insurance of the cargoes and carrier responsibility if necessary
  • Delivering all clinical trial materials and medications to the research centers
  • Temperature tracking in cool-chain delivery
  • Shipment of biosamples to a central laboratory
  • Purchasing and distributing additional equipment, various accompanying materials and supplies

Distribution and Drug Storage

Outsourced warehouse facilities in all countries of activities of OCT include:

  • restricted, computer-controlled access to the storage spaces
  • quarantine chamber
  • fully computerized temperature and humidity control
  • warehouse facilities allow to store medications at different temperature modes, research protocol conditions and sponsor requirements
  • multiple refrigerating modes from +8 to -10 , from -10 to -40 , from -40 to -86
  • alarm systems with preset values responding to power outages and temperature fluctuations
  • providing daily graphs, others

Investigators’ Meeting Organization

  • Inviting and summoning all investigators and representatives of the research sponsor
  • Working out the meeting schedule, advertising materials and other supporting tools
  • Translating materials for the meetings
  • Offering all required working materials of the meeting to the investigators
  • Preparing presentations
  • Selecting convenient venues, including workshops and banquettes
  • Negotiating contracts with service personnel
  • Hotel reservations, visa support, traveling assistance
  • General administrative support
  • Arranging for audio- / video- equipment, Internet access
  • Simultaneous translations

Quality Assessment

  • Providing accuracy and compliance to GCP and country-specific regulatory, applicable SOPs of data
  • Maintaining SOPs, conducting QA of sites and subcontractors
  • Organizing sponsors audits
  • Others

Medical writing

  • Design and preparation of Investigator brochures, Study protocols, Case report forms, Informed consent forms, other study related documents in compliance with federal/local requirements, ICH-GCP, FDA /EMEA standards is done by our team of 6 highly professional medical writers.


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Last update of this entry: August 25, 2015

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