Medical Affairs

Noahpharm owns a group of high-quality clinical experts and a well-trained medical team, and enjoys a good reputation for acquiring the high-quality clinical trial data and meeting customers’ expectations on clinical development. Different from counterparts, we take into account products of different customers, design protocols using technologies such as bridging or exemption based on clinical quantitative pharmacology, and formulate for customers the practical and feasible clinical development strategy, which could greatly shorten the drug clinical development time and further cut clinical fee. Besides, we can independently design and conduct the clinical trial protocol for mass balance study.

Clinical Operation

Noahpharm provides customers with all-round clinical operation services covering from the early clinical trial to final approval for marketing of the drug. We are not only responsible for the sponsor, but also assume the same commitment for the patient, doctor, investigator and regulator. While establishing the team for your study, we will refer to our clinical experience and professional treatment knowledge, and ensure to provide the exactly solution for you.

Data Management & Statistical Analysis

Noahpharm can meet the customer’s specific data management and statistical analysis demand during the trial, and provide the customer with flexible and precise solutions through the whole process from study startup to the end of study, covering biostatistical services in all aspects of clinical development.

Quality Assurance

Noahpharm’s quality management system focuses on control of study specific risks, and ensures data integrity and subject protection and safety. In accordance with the quality management principles, GCP guidelines and pharmaceutical regulatory requirements, we follow the company policy and project control requirements and establish the complete operation department’s standard operation procedures (SOP) and quality management systems. Our quality assurance system ensures the protocol compliance and identifies quality risks.