Den Clinical Research specializes in a wide range of services to support Phase II to Phase IV clinical trials and site management. Our expertise encompasses the following areas:
- Site and Investigator Selection
- Ethics Committee and Ministry of Health Applications
- Site Coordinator Support
- Site Evaluation, Site Initiation, Monitoring, and Close-out Visits
Site and Investigator Selection: Den Clinical Research assists in identifying suitable research sites and investigators based on specific study requirements. We carefully evaluate site capabilities, patient populations, and regulatory considerations to ensure optimal site selection.
Ethics Committee and Ministry of Health Submission: We provide guidance and support in preparing initial dossier and performing submission to Ethics Committees and relevant regulatory bodies such as the Ministry of Health and Association of Public Hospital. Our experienced team ensures compliance with ethical and legal requirements for conducting clinical trials.
Site Coordinator Support: Den Clinical Research offers comprehensive support to site coordinators throughout the trial process. We provide training, guidance, and ongoing assistance to ensure efficient site management and adherence to study protocols.
Site Evaluation, Site Initiation, Monitoring and Close-out Visits: Our team facilitates smooth site evaluation, site initiation, conducting monitoring visits to ensure protocol compliance, data accuracy and patient safety. We also provide support during site close-out, ensuring proper documentation and regulatory requirements are met.
Informed Consent Form Design: We collaborate with study sponsors and investigators to design clear and comprehensive informed consent forms regarding local regulatory requirements. These forms ensure that participants fully understand the study procedures, potential risks and benefits before providing their consent to participate.
With Den Clinical Research's expertise in Phase II to Phase IV clinical trials and site management, you can rely on our comprehensive services to support your research endeavors. Our dedicated team is committed to ensuring high-quality trial execution, data integrity and regulatory compliance throughout the entire clinical trial process.