Departments
07 in clinico
07 in clinico: Clinical Translation & Regulatory Compliance
Introduction
Our in clinico Department at INVITROVO is dedicated to guiding biomedical innovations through the final and most critical phase: clinical application. We provide comprehensive, end-to-end clinical research support, helping you transition from preclinical success to real-world human testing with confidence and full regulatory compliance. Our services span the entire process, from the submission and acquisition of ethical approvals to clinical study design, patient recruitment, and on-site testing, ensuring every step aligns with national and international clinical research standards. All clinical activities are conducted under the supervision of licensed clinicians, clinical researchers, and regulatory experts to ensure patient safety, data integrity, and scientific reliability
Aim
The strategic aim of the In Clinico Department is to accelerate clinical validation while upholding the highest ethical and safety standards. We achieve this by focusing on three core objectives:
- To Navigate Regulatory Hurdles: To efficiently manage the submission and acquisition of ethical approvals and ensure every study aligns with national and international clinical research standards.
- To Guarantee Study Integrity: To design scientifically robust study protocols and oversee on-site activities, including sample collection, testing, and vital sign monitoring, ensuring data is reliable and scientifically sound.
- To Ensure Patient Protection: To work closely with Institutional Review Boards (IRBs) and Ethics Committees, prioritizing patient safety, informed consent, and meticulous adverse event reporting throughout the clinical trial process.
Scope
The operational scope of the 07 in clinico department encompasses the entire clinical research lifecycle, providing hands-on support from preparation through validation. We provide comprehensive support covering:
- Ethical and Regulatory Preparation:
- Preparation and submission of ethics applications.
- Collaboration with Institutional Review Boards (IRBs) to accelerate approval processes.
- Clinical Study Design and Management:
- Study protocol design and creation of comprehensive regulatory documentation.
- Patient enrollment and management of the informed consent process.
- On-Site Clinical Support:
- Coordination of on-site sample collection and clinical testing.
- Continuous vital sign monitoring, symptom tracking, and adverse event reporting.
- Data Analysis and Follow-Up:
- Conducting longitudinal follow-up and clinical outcome analysis to validate results.
- Ensuring data integrity and scientific reliability throughout all phases of human testing.
Meet the Experts
Dr. Hanif Tabesh
Dr. Mino Shafiee
Prof. Dr. Farah Farzaneh
Offered Services
07 in clinico
• Proof of concept clinical study
• Phase I clinical trial
•And More
