At KONEXIO BIOTECH, we offer a wide range of clinical services designed to support all phases of clinical studies. We begin with the preparation and review of essential documentation, which includes sample size calculation and study design, as well as drafting and reviewing the protocol, patient information sheet, and other study materials. Our team also handles the design of data collection notebooks, ensuring efficient updating and extraction of data. We provide scientific consultations with regulatory agencies and manage all necessary procedures to obtain approvals from ethics committees and regulatory bodies, including the submission of studies on platforms such as clinicaltrials.gov, ReEC, and CTIS. We closely follow all regulatory procedures throughout the study, ensuring strict compliance with current regulations.

Study monitoring is another key area of our clinical services. We develop a detailed Monitoring Plan and conduct initiation, monitoring, and close-out visits to ensure the study is conducted according to established protocols. We manage the collected data and resolve any discrepancies or queries that may arise during the process. Additionally, we handle the preparation and management of the investigator's file, and provide pharmacovigilance services for reporting adverse events and recording the medication used in the study. Our thorough monitoring ensures the integrity and validity of the data throughout the entire clinical study.

Finally, at KONEXIO BIOTECH, we focus on comprehensive project management, effectively coordinating all participants, including sponsors, researchers, and collaborating companies. We conduct continuous team follow-up through regular meetings and provide guidance throughout the study. Our team also handles statistical analysis, developing a detailed Analysis Plan and generating charts and tables of results for publication. We conclude with the preparation of the final results report and provide support to researchers in the review process, ensuring that findings are communicated clearly and effectively. Our commitment is to offer a complete and personalized service that guarantees the success of each clinical study.