Experience and expertise in each phase of VCRO
As a professional CRO company, VCRO started with clinical trials of new drugs and new medical materials, accumulated more than 600 clinical project experience, and guided countless new pharmaceutical product manufacturers towards clinical development. In nearly 30 years of clinical experience, has accumulated more than 40 experience in the field of medicine, adhering to the strengths of VCRO is good at innovative drugs, innovative medical materials and innovative fields, and completed the phase I ~ IV clinical trials of partner customers.
Phase I clinical trials are the first phase of human trials of innovative drugs, usually the first time that the drug is tested in humans (first-in-human, first-in-class), the main objective is to explore the pharmacokinetics (PK) of safe dosage and drug absorption, distribution and metabolism in the human body. In this multi-purpose and highly configurable trial, VCRO started with the design of the trial, convened the Data Security Committee (DSMB), held DSMB meetings between the dose groups, and ensured that the PK data was compatible with the DSMB meeting.
Phase II clinical trials explore the effectiveness of a drug in a small patient population. VCRO performs such therapeutic initial clinical trials, specializing in the design and analysis of the relationship between effectiveness and dose, as well as the analysis of the efficacy of different disease conditions and different patient types, which effectively helps partner clients to adjust the preparation, dosage form and dosage, and lock the target patient population before the phase III pivotal trial.
Phase III clinical trials to validate the efficacy and safety of the drug are performed in large patient populations and are the closest trials to post-marketing use. VCRO has a wealth of experience in assisting clients to design more efficient trials by strategically applying the regulation’s special qualification and acceleration mechanisms. Through cross-regional resources, the layout of the trial execution hospital, the control of patient resources, and the tracking of reward receipt progress to ensure the smooth execution of the trial.
Phase IV clinical trials Trials evaluating the safety and efficacy of long-term treatment are investigational clinical trials. VCRO specializes in the integration of Real World Data (RWD), designing and performing retrospective and observational trials for clients, and applying VCRO’s data processing and statistical analysis expertise to bring together valuable clinical data trends as the cornerstone for clients to develop new clinical research pipelines.