A final clinical trial report is prepared for submission to the relevant authorities.
If requested, an article is written about the study.
A final clinical trial report is prepared for submission to the relevant authorities.
The final analysis is made from the cleaned data.
The data in the case report form is entered into the database by two different people and checked.
It covers all the services related to the study, including reaching the conclusion that there are no outstanding actions related to the work, ensuring that all queries are resolved, all payments are m
It covers the clinical trial site coordinator service to assist the investigator during the conduct of the study at the site in line with the sponsor's request. 0.5 FTE or 1 FTE service is provided.
It covers the preparing an e-bulletin on the current status of the work and sharing this e-bulletin with the sites at the end of each month.
It covers any translation related to the study. It is prepared according to the ATASEHIR CRO work instructions and submitted to the sponsor together with the signed translation certificate.
It covers the process starting with the first site opening of the study until the completion of the study. It refers to the management of the study sites by the project manager, quality manager, and c
It covers the process starting with the first site opening of the study until the completion of the study. It refers to the management of the study sites by the project manager, quality manager, and c
It covers services such as updates, changes and presentations about the study from the previous visit to the next visit, preparing the forms to be collected during the visit, requesting an appointment
It covers the services related to the study in which all the processes related to the study are first studied by the monitor, the forms to be collected during the visit are prepared, an appointment re
It covers the preparation of the database necessary for the analysis of the study.
It includes the preparation of contracts between the selected laboratories of the tests to be studied related to the research and the sponsor or ATASEHIR CRO, and the completion of the signature proce
It covers the service of filing the cover letter, application form and amended documents for the presentation in case of a change in the documents or situation related to the study and making the pres
It covers the service of filing the cover letter, application form and amended documents for the presentation in case of a change in the documents or situation related to the study and making the pres
After trial approval, there may be updates to the trial protocol, informed consent form or case report form until the trial is completed. This service covers the update of each document.
After the initial application file is reviewed by the Ethics Committee and/or the Ministry of Health, some corrections and clarifications may be requested in the application file. This service item co
It includes the service to register all information and updates of the clinical study on clinicaltrials.gov.
It includes the preparation of the project management file related to the clinical study, which will be kept in the ATASEHIR CRO office from the beginning until the completion of the study and will be
It includes the preparation of files containing all information and documents related to the study to be sent to the trial sites before the site initiation visits.
It includes a site visit to select the sites before the study starts. ATASEHIR CRO is predictive in site selection with its past experience. One of the most important factors affecting the success of
If there is a site affiliated with Public Hospitals (e.g., Training and Research Hospitals), after obtaining approval from the trial Ethics Committee and the Ministry of Health, it is mandatory to obt
After the approval of the Ethics Committee and the Ministry of Health, a trial study contract is made with the trial sites. This contract is signed by the institution, the investigator, and the sponso
It includes the preparation of the initial application file of the research to the Ministry of Health, submission to the Ministry of Health, scanning all documents and sending the scanned version of t
It includes the preparation of the initial application file of the research to the Ethics Committee, submission to the Ethics Committee and scanning all documents and sending the scanned version of th
It includes the preparation and collection of documents such as CV, IKU-Helsinki documents, research protocol signature pages, I read the investigator brochure documents, confidentiality documents, au
PREPARING THE CASE REPORT FORM COMPLETION GUIDE: A guide on how to complete the case report form is prepared and users are trained. PREPARING MONITORIZATION GUIDE: A guide on how to perform study mon
It is the document in which the sponsor (person or organization) undertakes that the payments related to the trial protocol, other concurrent treatment, and trial-induced rescue treatment costs forese
This service includes the preparation or adaptation of patient cards, patient diaries, questionnaires, instructions for use, application instructions, information texts, posters, brochures, informatio
All documents used only to inform the trial team, such as investigational product application instructions, information texts, doctor's letters, etc. are prepared by ATASEHIR CRO in accordance with th
Insurance coverage is provided in the event that volunteers participating in clinical trials are exposed to damage or death due to the investigational products used during the clinical trial and the p
An informed consent form (ICF) is a written document indicating that the volunteer decides to participate in the trial of his/her free will after the volunteer or, if necessary, his/her legal represen
Investigator Brochure: Documents pertaining to non-clinical and clinical data related to the investigated product or application. It is prepared for the Ethics Committee and Ministry of Health applic
E-LEARNING: It is the service that ensures that all training related to the project, legal legislation, ATASEHIR CRO SOP/WI, and supporting SOP/WI are provided as e-training for the personnel involved
E-TMF: It is a project-specific system service created for the storage of all documents and/or files created and collected related to the study from the beginning to the end of the study in an electro
WTRS : In studies requiring randomization, it is a system where research products are assigned to volunteers through an electronic environment, confirmation of the receipt of research products from th
Case Report Form (CRF): A printed, optical or electronic document prepared to record the data and other information of each volunteer in the study as defined in the study protocol. ATASEHIR CRO can de
An informed consent form (ICF) is a written document indicating that the volunteer decides to participate in the trial of his/her free will after the volunteer or, if necessary, his/her legal represen
The quality of a study depends on the quality of the trial protocol. Therefore, when a study is designed from the very beginning, the more details are mastered and the whole is reached, the closer the
It is a document that defines in detail the purpose, design, methodology, statistical methods to be applied, and the regulations of the clinical trial. ATASEHIR CRO designs the research protocol toget
The calculation of the sample size is carried out while the research is still in the design phase. In research, multiple variables of different types are often examined with separate statistical tests
