CRO

We assist sponsors in determining the most appropriate studies or design according to parameters such as drug and/or device safety, study feasibility, optimal approval strategies, validity, scientific interest, and investment profitability. Our team applies intelligence and creativity to develop a comprehensive global strategy that minimizes resource utilization and facilitates the introduction of medicine into multiple major markets. By incorporating a well-designed global plan, we aim to prevent redundant efforts and streamline the adaptation process to meet international standards and specific regulations in each country. Our experts share their knowledge to design effective programs that enable compliance with country-specific regulations and facilitate optimal distribution of medical devices and drugs. 

Through our Clinical Operations department and medical team, we provide support in selecting principal investigators and highly skilled healthcare professionals for each therapeutic area, ensuring their commitment to the study. We have already established excellent relationships with the investigators we have worked with, which enables us to earn their confidence and achieve success in every investigation we undertake. They are our primary prescribers.

Additionally, with our extensive database of investigators, we could also assist sponsors in selecting the best sites across Europe. Our site selection system and database ensure the feasibility of site services (Pharmacy, Laboratory, Imaging Service, General Resources, and Human Resources) based on the specific needs of the study.

We have extensive experience in facilitating the communication and coordination between the sponsor's internal regulatory affairs department and government agencies and competent authorities at the local, regional, national, and European levels. This helps us to achieve approval for studies and clinical trials by simplifying the entire process and reducing associated costs. We collaborate with an extensive network of sites and their Ethics Committees, enabling us to minimize resource utilization and ensure EC approval for each project we undertake. 

As a crucial element in the development of any trial or study, we play an intermediary role and offer legal guidance in negotiating contracts between the Sponsor and all participating vendors, ensuring compliance with local regulations. Our specialized team is exclusively dedicated to contract negotiation with sites and has a proven track record of successfully negotiating site and vendor contracts. We have established strong relationships with individuals responsible for contract negotiation at various sites. 

We understand safety vigilance as the pharmacovigilance process of monitoring the safety of developmental medicinal products (DMPs), authorized medicinal products (AMPs), and medical devices. Our aim is to identify and evaluate adverse reactions in order to reduce risks. We provide a high-quality vigilance service that covers the entire product lifecycle, from inception to completion. Our approach includes developing a customized safety system plan for each product, in compliance with the guidelines outlined in the EU legal framework for good pharmacovigilance practices. 

We also have a procedure and system in place to review and conduct quality check controls for completed studies, as well as ongoing studies conducted by other parties. This way, we can ensure that the study and all associated documentation are in optimal condition and prepared for potential inspections by regulatory authorities.