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The 6th Vaccine Innovation Forum (VIF World 2025) was held in Shanghai, China from March 20 to 22 attracting over 1,000 global experts from over 30 countries to discuss vaccine R&D progress and development trends.
Dr Mo Zhaojun, General Manager of SDM Shanghai, the vaccine business unit of SDM, delivered at a group session 'Vaccine Clinical Trials: Practical Insights to Avoid Pitfalls. With nearly 20 years of experience as a principal investigator, Dr Mo shared his valuable insights on overcoming common trial challenges - covering regulatory requirements, sponsor needs, investigator quality control, and CRO collaboration. The session provided practical solutions for ensuring trial quality and efficiency while aligning with global vaccine development best practices.
Dr Mo emphasized that successful vaccine trials depend on strong collaborations among sponsors, investigators, CROs, patients and vendors.
When planning vaccine clinical development, Dr Mo stressed that protocol design must prioritize key regulatory requirements. This includes: Leveraging preclinical data insights, ensuring scientifically sound trial design (endpoints, target populations, sample size), incorporating learnings from similar vaccines while accounting for unique features (e.g., adjuvants/carriers), aligning statistical and medical strategies to present clinical results effectively.
For operational execution, Dr Mo advised defining clear timelines, enrollment plans and key visit milestones, supported by robust CRO monitoring, quality control, audit systems to ensure scientific and operational rigor.
Dr Mo shared practical strategies for avoiding pitfalls in vaccine clinical trials, emphasizing fulfilling responsibilities, effective communication, and mutual trust & complementarity - insights that strongly resonated with attendees.
Contact SDM and Dr Mo for vaccine development solutions and professional advice at any time.
This session focuses on Stakeholder Engagement: developing strategies for collaborative project decision-making and execution.
The updated draft guidance involves a focus on clinical trial design, regulatory considerations, and whether these trials can demonstrate that the drugs can maintain weight loss as determined by BMI.
Let's take a look back at the previous two installments of the Clinical Data Management “PM” series: Scope Management, which clarifies the scope of responsibilities of all parties involved in a clinical trial, and Project Resource Management, which focuses on the utilization of company and personal resources to accomplish data management tasks. In this installment, we will focus on the most important part of project management - project schedule management - to share the timeline planning and progress follow-up of data management activities, so as to efficiently complete the data management work under the premise of ensuring the data quality and reaching the important milestones of the project.
In the last session, we learned about project scope management for data management work, identifying the scope of responsibilities for data cleansing and data management activities. After defining the scope of the data management work, in this session, we will learn how to mobilize the resources within the scope of work to carry out the data management work more efficiently and with higher quality.
Shanghai SDM Vaccine Data Management Department, in collaboration with the International Project Department, has launched a series of training sessions on "Application of Project Management Knowledge in Data Management." The Application of Project Management Knowledge in Data Management Work contains eight modules, including Project Integration Management, Project Scope Management, Project Progress Management, Project Quality Management, Project Resource Management, Project Communication Management, Project Risk Management, and Project Stakeholder Management, etc. It mainly refers to the theoretical knowledge of the Guide to the Project Management Body of Knowledge (PMBOK Guide) and combines the content of the data management work and practical experience of the project.
Want to quickly penetrate the Chinese, American and European pharmaceutical markets? Registering for communication exchanges is the key!
SDM PV team detects drug safety risks.
SDM Vaccine Experts Share Roadmap to Avoid Clinical Trial Pitfalls.
this article outlines essential documentation preparation and strategic considerations for conducting pre-IND communication meetings with CDE, ensuring effective regulatory alignment and adequate guidance.
Clinical Database Design: Balancing Standardization and Innovation
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