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BY Yajie Li, Frank Gao & Yuexia Li Regulatory & Access, Parexel International - 8.20.20 -
Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special considerations. In China, in order to establish clear guidelines to optimize clinical trials during COVID-19, the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of the P.R.C (People’s Republic of China) summarized NMPA’s management experience and solicited the external opinion from the industry, including investigator and sites. This resulted in the introduction of Guidance for the Management of Clinical Trials during the COVID-19 pandemic, which was implemented in July 2020. The objective, scope and key points for the guidance are summarized as below.
The objective: To protect subjects’ safety and encourage responsibility by the sponsor to ensure the quality of clinical trials and data authenticity, accuracy, integrity and traceability.
Scope: The guidance applies to all drugs being developed during the COVID-19 pandemic, including COVID-19 drugs seeking emergency approval.
How Parexel can help:
Our 1,000+ consultants worldwide, including 80+ former regulators / inspectors / assessors, are optimally positioned to understand just what type of information biopharmaceutical companies need to share with the NMPA for their products and how to effectively collaborate to develop the most effective regulatory and product development strategies for new potential treatments in the combat against COVID-19 and other critical diseases.
Information cited in this article is from:
"During the COVID-19 pandemic, sponsors may choose to utilize digital technology to remotely manage the clinical trial. All aspects of such clinical trial management must be well planned and GCP compliant. Additionally, communications with regulatory authorities on the use of technology is highly recommended."
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