Quality has always been of special concern when choosing service providers in China. In the drug development service sector, quality levels are maintained by the observation of ICH-GCP, GLP and GMP standards, and service providers have an incentive to ensure quality services and stay competitive. However, issues at a detailed level could arise that come with different interpretation of protocols, standard procedures different from those in the West, the training level of those carrying out the studies, or negligence due to work overload. These issues could impair the study outcome, and preventing them requires not only a well-designed SOP, but also careful day-to-day project management and problem solving.
Project managers assigned by CROs typically have a few shortcomings. They may be limited in experience (usually 2-3 years in the industry after college) and thus may not understand your product and disease well; they tend to be limited in English with varying communication skills; they tend to have a high turnover rate (six months to a year at a firm is typical;) and they are often overcommitted and may have difficulty giving your project the attention it deserves. (In some companies, a CRA can be working on six projects at the same time.) Most importantly, a project manager assigned by a CRO works for the CRO and does not act in your interest in situations of ambiguity.
One of our most important tasks is going beyond finding you the right partner and managing their work to make sure your project is delivered on time with the quality that you need. Once the project starts, we can assign a dedicated project manager for you as your representative in China. They assume three major roles: First, the PM stays in close communication with you, and gives you day-to-day monitoring and control of the project. Second, on-the-ground project management allows for early detection and resolution of any unexpected problems. Third, the PM acts as the liaison and buffer between you and your service providers in China. If the situation requires, the PM can resolve issues and defuse potential conflicts.
Our project managers are bilingual professionals, typically with 5-10 years experience in their specific domain. They are experts in the development process with first-hand experience in drug and device development. We also implement internal mechanisms to overcome the fast turnover rate prominent in the industry, to ensure the completion of your product development.
To find out more about our project management capabilities, please contact inquiries@modularrandd.com.