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Clinical studies are an integral part of the medical field, driving the progress of knowledge and the development of innovative treatments and therapies for patients. In order to ensure success, it is crucial to focus on three key elements: proper preparation, diligent monitoring, and building strong relationships with hospitals.; by paying attention to these aspects, you can pave the way for a smooth and effective clinical study
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+39 347 1468757
Office Email
info@kronemed.com
Office Location
Via Granito di Belmonte 41
00121 Rome
Italy
Email: info@kronemed.com
The optimal approach to manage clinical studies
Study Protocol
The study protocol is a detailed plan outlining the objectives, design, methodology, eligibility criteria, data collection, and analysis methods. It serves as a blueprint for the entire study and must be carefully developed and reviewed.
Ethical Approval
Before commencing any clinical study, obtaining approval from an institutional review board (IRB) or ethics committee is mandatory. These bodies ensure that the study is scientifically valid and ethically conducted to protect the rights and safety of study participants.
Regulatory Compliance
Complying with all relevant regulatory guidelines and requirements is crucial to ensure the study’s legitimacy and adherence to good clinical practice (GCP) standards.
Site Selection
Identifying qualified investigators and suitable research sites (hospitals or clinics) is vital. Investigators must have the necessary expertise, training, and infrastructure to conduct the study effectively.
Patient Informed Consent
Adequate patient recruitment is essential for the study’s success. Obtaining informed consent from participants is a critical ethical requirement, ensuring they understand the study’s purpose, risks, and benefits.
Site Selection and Initiation
Monitoring Visits
Monitoring visits to the clinical site during the study, monitoring that the study to ensure that it adheres to the study protoco, confirming that patients are enrolled according to the inclusion and exclusion criteria and that the study procedures are being followed correctly
Adverse Event Reporting
Communication
Site Training
Providing training to site staff on GCP, study procedures, and any specific requirements of the study
Site Closeout
Ensuring the integrity of clinical trial data and patient safety, uccessful completion of clinical studies and the submission of reliable data to regulatory authorities for the approval of new drugs, medical devices, or treatments.