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Our Services

Central & Eastern Europe Research Institute - CEERI/Turkey offers a wide array of services for clients. CEERI/Turkey is generally a Site Management Organization (SMO), however, we are versatile in functionality and can operate as a Clinical Research Organization (CRO) as well, performing all essential functions.

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Our Services:

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There are many advantages of hiring CEERI/Turkey when looking to expand to our region of the world including our expertise in what we do, qualified and experienced staff, our extensive network of affiliated investigatory sites and the cost-effective and quality clinical research environment in the countries in which we operate.

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The central and eastern European region provides a high quality yet cost-effective climate for conducting clinical research which many of the world's largest pharmaceutical companies have entered and taken advantage of the benefits to their success.

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Advantages:

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  • 25-30% lower operating costs than western countries

  • Quick clinical trial approval

  • Rapid patient enrollment

  • Quality and accurate clinical trial results

  • High clinical site productivity

  • Advanced and highly developed clinical infrastructure

  • High clinical trial potential in most major therapeutic areas

Site Management & Monitoring

CEERI/Turkey supports clinical studies across a large number of clinical sites in central and eastern Europe as well as the Balkans. In order to facilitate multi-site studies for pharmaceutical companies that require large patient population coverage, CEERI/Turkey provides a centralized process of managing and monitoring sites with robust IT infrastructure and is staffed by highly qualified individuals. This enables companies to handle several sites at the same time with no incremental resources or costs. 

CEERI/Turkey Site Management Services:

  • Study Site Feasibility and Qualification - According to Protocol Requirements

  • On-site Investigational Team and Study Staff Training

  • Patient Recruitment

  • Archiving Trial Documentation and Quality Control


Our Clinical Research Coordinators and Monitors follow Sponsors' or our own Standards of Practice (SOP's). We are also able to use our own monitoring plans and procedures and GCP (Good Clinical Practice) online training.

 

CEERI/Turkey Monitoring Services: ​

  • Pre-study Site Evaluation Visits

  • Investigator Assessments

  • Investigator Enrollment

  • Study Site Feasibility

  • Study Site Initiation Visits

  • Regulatory Document Preparation and Collection

  • Budget and Contract Negotiation

  • Staff Training

  • Documentation Maintenance and Updating

  • Study Development Monitoring

  • Study Site Close-out Visits

 

CEERI/Turkey staff trained to:

  • Clarify protocol issues with the investigational team

  • Handle protocol amendments

  • Review source documents related to clinical study data

  • Report adverse events

  • Ensure patient safety and enrollment procedures

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*CEERI/Turkey's services are conducted in accordance with ICH and GCP guidelines and local regulatory requirements.

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Biostatistics

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CEERI/Turkey Biostatistics Group consists of biostatisticians and consultants who are faculty members at leading universities in Turkey. The group collaborates with biostatisticians from other global research institutions, therefore it can meet sponsors needs of all levels of sophistication in biostatistical services, whether in study design or analysis. CEERI/Turkey can assist pharmaceutical companies/sponsors with expertise accumulated from years of experience in clinical research and medical care. We encourage our clients to consult with us as early on as possible. 
CEERI/Turkey Biostatistics Group was formed as a research team dedicated to biostatistics and clinical research. CEERI/Turkey has an important role in developing and applying biostatistical methods to clinical studies and health outcomes.

Lab Services

LAB

Clinical research studies lab services are supported by hospital based and outpatient service centers. CEERI/Turkey also cooperates with central labs suggested by sponsors.


Laboratory staff are highly experienced scientists committed to quality, access and cost effectiveness. The Laboratories network supports all types of needed lab work and is able to transport lab samples from remote sites to main hospitals.

The pathology staff includes a physicians board certified in anatomic and clinical pathology as well as sub-specialties certified in cytopathology, immunopathology, chemical pathology, transfusion medicine, clinical microbiology, hematopathology, dermatopathology and oral pathology. Our pathology staff provide medical and technical consultations and interpretations every hour of the day, every day of the year. Our certified and registered clinical laboratory professionals provide the knowledge and experience to support clinical studies.

CEERI/Turkey provides a full range of clinical laboratory services. With highly qualified lab technicians and specialty MDs, CEERI/Turkey labs are operated in strict compliance with regulatory standards and with a focus on quality assurance and quality control. CEERI/Turkey provides laboratory services for clinical research projects in all phases. Analyses are performed on the day of receipt. Upon request, re-analysis of abnormal values will be performed.

Data Managment

DATA

At CEERI/Turkey , we realize the importance of proper Data Management for the accuracy and safety of data. Therefore, we employ advanced tools lead by staff with extensive experience in data management.

Our Data Management services include:

  • Database Design

  • Forms Management

  • Web Interface and Graphical User Interface (GUI) for each study and per pharmaceutical company's/sponsor's requirement

  • Database Programming

  • Medical Coding

  • Case Report Form Design: electronic and paper versions

  • Data Entry and Status Reporting


We support most commercial Electronic Data Capture (EDC) software and can assist sponsors in designing and engineering a tailored EDC interface for their unique study.

CEERI/Turkey's goal in clinical trial management is to facilitate the planning, execution and tracking of relevant clinical trial activities. We have a clinical trial management solution built in-house.

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Benefits of our in-house solution:

  • Improved Process Planning

  • Model Visit Schedules

  • Standardized Data Collection Processes

  • Provide single access to multiple clinical processes including Electronic Data Capture (EDC), data management, and adverse events reporting

  • Exchange critical documents electronically and securely

  • Integrate with budgeting and finance applications

  • Provide study sites with online access to sponsor and CRO information, archived documents and frequently asked questions (FAQs)

Regulatory Services

regulatory

CEERI/Turkey provides regulatory services to pharmaceutical companies/sponsors and institutions in several regulatory areas: 

  • Regulatory Consultation on FDA, GCP, HIPPA Compliance

  • Informed Consent Design

  • Protocol Writing

  • Preparation and Filing of investigator-initiated IND/IDEs

  • Safety Reporting to regulatory bodies

  • Clinical Study Reports


CEERI/Turkey also prepares, maintains, tracks and submits clinical trial applications to regulatory authorities and reviews clinical trial documentation to ensure compliance with all applicable GCP (Good Clinical Practice) and regulatory guidelines.

Our regulatory affairs specialists work closely with clinical study monitors to ensure that safety information is appropriately collected, evaluated and reported, including serious adverse events and other significant safety events.

At CEERI/Turkey, we manage and compile the documents required for pharmaceutical regulatory affairs, IND and NDA submission. The submission involves all documents containing the details of a new drug or medical device and clinical trial.

Our staff offers solutions to meet various challenges for pharmaceutical, biotechnology, diagnostics and CRO industries.

Business Models

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Full-Service Model

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  • CEERI/Turkey has the resources and capabilities to undertake most clinical trial projects internationally and act as a full-service Contract Research Organization (CRO)

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  • The full-service model is ideal when pharmaceutical companies/sponsors have limited resources and deployment of additional staff is costly or impractical

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  • In this model, CEERI/Turkey contracts with medical institutions to conduct clinical trials

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  • Clinical Trial Agreement (CTA) and payments are between CEERI/Turkey and the medical institution. CEERI/Turkey commits to payments and is paid by sponsors

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Functional Service Provider Model

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  • The Functional Service Provider (FSP) Model is ideal when pharmaceutical companies/sponsors only need assistance in certain functions or geographic locations or need additional staff to support current in-house departments or functions

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  • FSP is very flexible and varies from project to project

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  • All contracts, payments and legal framework are executed by two sets of agreements:

    • Master Service Agreements (MSA) that deals with the general deliverables

    • Statements of Work that deal with specific parts and sections

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Hybrid Model

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  • The Hybrid Model deals with the structural and support gaps between pharmaceutical companies/sponsors and Contract Research Organizations (CROs) on one side and investigators and sites on the other

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  • We embrace the Hybrid Model that emphasizes Contract Reserach Organization (CRO)/Site Management Organization (SMO) support systems in several international locations in central and eastern Europe

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  • The Hybrid model enables CEERI/Turkey  or any of its affiliates to completely compliment sponsors’ resources to manage studies, whether they have another CRO or they manage the study without a CRO

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