DESIGN and REGULATORY

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.

CRF Design:

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.

The Best Outsourcing Solution!

Full service CRO with Customer-Oriented project management and proposals

Excellent expertise with more than 350 completed projects.

High level of customer satisfaction with dedicated team work and synergy.

Clear strategies for your projects starting from the beginning.

Project and staff stability.

Quick start-up timelines with good communication to the ECs and RA.

Flexible, proactive, professional teamwork.

Competitive costs, Efficient processes

Open communication to our clients and employees

Good risk mitigation processes and planned business continuinity

Quality Certificates such as MoH GCP Certificate, ISO:27001 Information Security Management.

Micromanagement on project and site performence.

High patient recruitment level and efficient patient retention policies.

Recruitment strategies for targeted populations.