Designing of a clinical study starts with good established systems supported by reliable standard operating procedures and well known regulatory processes. One of Klinar’s best ability is to help you on deciding how to move forward with your projects for the solutions. In this regard Klinar provides the below services:
● Developing Standart Operating Procedure and giving necessary counselling in this regard,
● Providing central audit and system audit counseling and staff hiring
● Designing and conducting of pharmaceutical studies, observational studies, medical device studies, pattern studies, pharmacoeconomy studies, compassionate use program, ATMP studies and other gene theraphy studies
● Preparation of study support material and process management (Guideline, patient cards, physician information cards, brochures,newsletter, e-newsletter etc.)
● Preparation of Ethics Committee and Ministry of Health Submission Files,
● Submission Follow Up and Approval
Our services also include:
Investigator Meeting Organization:
Klinar CRO organizes investigator meetings at the start of the study, during the study and/or at the end of the study. These meetings are conducted in order to provide study specific information to investigators, to increase patient recruitment, to evaluate the current state of the study and/or to inform investigators about the progress of study. Meeting agenda is prepared in cooperation with sponsor and meeting binders can be prepared by Klinar CRO if requested.
This service includes design of study CRFs by project coordinators according to the study protocol and final review is performed by QC unit.
Study Protocol Design:
In the protocol design procedure, overview of the study is discussed with sponsor and requested parameters are assessed. Trial protocol is finalized by a statistician and a medical advisor who is a specialist in the therapeutic area of the study. In this process, comments from sponsor and/or investigators are also taken into consideration.