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CROTURK, is a leading and pathbreaking foundation for conduct, organization and improvement of clinical researches in Turkey
CROTURK, a member of DIA, EUCROF and SAKDER (Association of CROs in Turkey) , is a CRO working in full compliance with the principles of “Guideline For Good Clinical Practices” under the relevant legislation
GENERAL OVERVIEW
2015 2014
In addition to the main office based in Ankara, CROTURK provides home based personnel all over Turkey depending on the project needs
CROTURK, provides staffing solutions to Sponsor companies in following titles,
› Study Coordinators› Data Entry Specialist› Clinical Research AssociatesProviding services with the team of experts in the fields,
CROTURK is aiming to achieve excellence with the precise structure, well-established infrastructure and with innovative management policy
2015
GENERAL OVERVIEW
2014
In addition to all of the design services (protocol, PIS/ICF, CRF,eCRF etc.), medical writing and translation services are performed under the supervision of the General Manager
Quality of the services provided by staff are controlled by the Quality Department and the requirements for the sponsor SOPs are insured
2015
GENERAL OVERVIEW
2014
Our team has a wide range of experience in different therapeutic areas,EXPERIENCE
2015 2014
FEASIBILITY STUDIES
2015
Cooperating with the sponsor company for the selection, in order to select Investigators who can work in compliance with the GCP regulations.
Providing information regarding Ethics Committee procedures and recommendations
Providing information about the efficiency of the sites that are planned to be included in the studies and the patient population,
Investigation of imaging centers organization, central laboratory, and the feasibility of the sample abroad delivery services
2014
EC SUBMISSION AND FOLLOW-UP
Study protocol translation,CRF design,Preparation and delivery of the Ethics Committee Submission
Dossier,Ethics Committee submission, revision and approval follow-up,Ministry of Health submission revision and approval follow-up,Ethics Commitee Submission (copy) dossier preparation for the
Sponsor,Protocol amendment and ICF translations
2015 2014
MONITORING
2015
Investigator’s file preparation,Monitoring visit form preparation,Site selection, initiation, periodic and close-out monitoring
visits,Periodic (monthly)reports to the sponsor company,Reporting to the sponsor company after each and every
monitoring visit,
2014
2014
Contacting with the sites and collecting information about enrolment rates/plans, adverse event submissions, supply/device requirements and other issues and transmitting them to the sponsor company,
Annual Notification and Study Final Reports preparation,
Serious Adverse Event (SAE) notification
MONITORING
2015
DATA ENTRANCE AND ANALYSIS
2015
Database formation,Dual data entry,Amendment lists formation,Amendment lists resolution,Interim analysis and preparation of the reports in the studies if required,End of Trial Analysis preparation and reporting
2014
EPIDEMIOLOGICAL STUDIES
2015
Implementation of the study design and performing sample size and other statistical calculations for the studies,
Performing the investigator selection with the sponsor companies by using the database including the investigator’s information participated to the clinical studies conducted before,
Study patient enrollment forms design, Study protocol preparation, Sending the enrollment forms to the investigators
participating to the study,
2014
In order to collect data from the sites, performing monitoring at certain interval visits,
Reporting about the collected data regularly, Performing interim analysis about the collected data , if
needed, At the end of the time determinated, analyzing the whole data
after the study is completed, End of Trial Report Notification
EPIDEMIOLOGICAL STUDIES
2015 2014
MARKETING STUDIES
2015
For the studies and implementation of the study design, performing sample size and other statistical calculations ,
Identification of the units in which the investigation will be performed, in accordance with the following study type,
Data collection in between identified intervals, Regularly collected data reporting, Performing interim analysis about the data collected, if
needed, Analyzing the whole data after the study is completed, Performing the required assessments and presentation of the
marketing strategies
2014
ELECTRONIC DATA STUDIES
2015
Performing sample size and other statistical calculations for the studies and implementation of the study design,
Contacting with medical association and other type of organizations related to the therapeutic area that the study is going to take place,
Preparation of the study according to the scientific consultancy and suggestions of these associations,
By using the database which includes the investigator’s information who has participated to the clinical studies conducted before, performing the investigator selection with the sponsor companies and the scientific consultant medical association,
2014
As the data are collected online, performing a prestudy to identify the technical efficiencies of the sites
Study protocol preparation, Study patient enrollment forms design, In order to be transmitted to the electronic environment,
providing the designed patient enrollment forms, Preparation of the technical infrastructure which every site
can follow it’s own enrollment from, (generating an account by providing each site a password and a username),
At first providing all data entry to be online but also providing the sites which can enroll offline to be included in the system by us,
ELECTRONIC DATA STUDIES
2015 2014
Regular reporting about the collected data to the sponsor company and to the scientific consultant,
Performing interim analysis about the collected data if requested,
At the end of the time determinated, analyzing the whole data after the study is completed,
Notification of the End of Trial Report, After the end of the study, publishing the whole system on the
consultant medical association’s and institution’s web site, Providing the whole entered data which can only be used by
the the sponsor company in charge of the study and scientific consultant
ELECTRONIC DATA STUDIES
2015 2014
SOFTWARE STUDIES
2015
Performing the software programmes which are related to the required therapeutic field,
Copying the software, Preparation and printing of the software user’s manual, Turn all the prepared materials into products that will be
presented to the investigators, Providing the distribution of the softwares to the doctors that
are identified by the sponsor company,
2014
Installing the programme into computer, organizing the meeting regarding the data recording methods,
Providing the consultancy service about the application process issues,
Collecting and reporting data regularly,
Analyzing the collected data up on request
SOFTWARE STUDIES
2015 2014
MEDICAL DEVICE STUDIES
2015
Implementation of the study design, performing sample size and other statistical calculations for the studies,
Researching the devices about the therapeutic field that the study will be conducted and the implementation of these devices to the drug which will break into market,
Performing the investigator selection with the sponsor companies by using the database including the investigator’s information who has participated to the clinical studies conducted before,
2014
2015
Study protocol preparation,
Patient study enrollment forms design,
Sending the enrollment forms to the investigators who will participate to the study,
With the company representative providing the medical device, performing investigator visits and explaining device utilization and data recording management,
MEDICAL DEVICE STUDIES
2014
2014
In order to collect data regularly, performing monitoring visits to the sites and investigators, Reporting to the sponsor company about the regularly collected data,Performing interim analysis about the collected data upon request,At the end of the time determinated, analyzing the whole data after the study is completed,End of Trial Report Notification
MEDICAL DEVICE STUDIES
2015
TRAININGS
Basic CRA Training: ICH-GCP, local regulations and project management,
CROTURK SOP, Basic Therapeutic Area Training: Medication indication,
therapeutic area trainings,Other Trainings: Orientation, ICH-GCP refreshment, time
management, project management, staff management etc.
2015 2014
QC & QA
Quality checks during the study regarding every project management related activity inorder to provide high quality
SOP complianceCo-monitoring/Site AuditsProject related document control/ Office AuditsStudy material inventoryArchiving (paper / electronic+ scanned)Training requirements
2015 2014
INTERNATIONAL PARTNERS
CROTURK’s collaboration with worldwide Clinical Research Associations and Institutions is a part of the organization’s continuous improvement and contemporary vision
2015 2014
THANK YOU...
20142015
