Management of Institutional Agreements for Clinical Research
The success of clinical trials depends on establishing a healthy collaboration between all parties involved. The foundation of this collaboration is laid through detailed and comprehensive institutional agreements. Clinical Trial Agreements (CTAs) ensure that the research is conducted in accordance with ethical, scientific, and legal requirements. These agreements are vital for clearly defining the responsibilities among research centers, sponsors, and investigators. Our service covers all processes necessary for the seamless progress of your clinical trials. From the initiation to the completion of the research, we provide professional support. Our experienced team prepares agreements in compliance with ICH-GCP, FDA, and EMA standards. Additionally, we follow the IKU guidelines in Turkey. By focusing on critical issues like confidentiality and data management, we create a secure environment for all parties involved. With our service, we guarantee quality and compliance at every stage of your research.
Negotiations and Document Preparation with the Revolving Fund Unit
For Clinical Trial Agreements (CTA), requirements are determined through communication with the Revolving Fund Unit. At this stage, all necessary documents for the research center are thoroughly prepared and presented to the relevant parties.
Public Hospital Approval Process
Application documents are prepared and submitted in accordance with regulations. The approval process is closely monitored, and support is provided when necessary.
Fulfillment of Revolving Fund Requirements
The Revolving Fund procedures are implemented for the employment contracts, and investigator agreements are prepared to ensure the completion of the process for each visit. Additionally, after the contract is signed, the project code creation process is completed.
Contract Amendments
During the study period, the agreement is revised and updated whenever protocol or fee changes are necessary.
Center CTA Closeout Visit Process
At the end of the study, the agreement is completed, the study code is closed, and the relevant documents are finalized.
Regular Reporting
All transactions are regularly reported and monitored. These reports are shared with stakeholders to provide information about the process.
Our Solutions
Contract and Approval Process Management
We ensure that the necessary documents are prepared and the approval process is closely monitored for the regulatory compliance of your clinical trials. By establishing effective communication with public hospitals and revolving fund units, we make sure your projects are aligned with legal and ethical standards.
Project Management
We ensure the professional execution of employment contracts and project code creation processes. We provide expert support to ensure that all processes are completed efficiently and on time.
Public Hospitals Approval Process
We prepare the necessary application documents in compliance with regulations and follow the approval process with the relevant authorities. We provide support when needed to ensure the smooth progress of your projects.
Continuous Reporting
We provide regular and detailed reporting to the sponsor throughout the research process. These reports are designed to include project progress and critical data, ensuring the transparency needed.
CTA Revision
In cases of protocol or fee changes, we revise your agreements quickly and efficiently. We provide up-to-date and comprehensive solutions to ensure compliance with the changing conditions.
Closure Process
When the research is completed, we finalize all documents by completing the CTA closure process. We ensure that your projects are closed in an orderly manner and ready for future audits.
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