George Clinical has recently expanded its China operations to include in-country Data Management services. This is in order to better manage the growing number of electronic data capture (EDC) trials that George Clinical is running in China, and to provide a local service solution for the Chinese R&D industry.
Yu Jia has been appointed as a Senior Data Manager, based at George Clinical’s Beijing office. He possesses extensive experience across Data Management and Biostatistics. Yu Jia joins us from a global contract research organization (CRO) where he led a team of data managers for a number of years. Prior to this, he held data management and statistical analysis roles at a global pharmaceutical and another global CRO. He is familiar with several Clinical Data Management Systems, such as Oracle Clinical, Oracle InForm and Medidata Rave.
The decision to place in country Data Management services in China is due to the dramatic increase in adoption rates for EDC in China. This has been fuelled by improved technology developments in mobile applications, and the increasing experience with EDC usage in clinical research. The number of regional and global studies in China, which typically uses EDC, is increasing, which in turn causes familiarity at site level to rise.
EDC adoption on the rise in China
There are many developments in the EDC environment that are encouraging its adoption in China. Infrastructure and technology limitations are rapidly being overcome, facilitating the growth of EDC trials. Some connectivity issues continue to a degree in China, particularly in the lower grade hospitals and community health centers. However, at major research hospitals, connectivity limitations no longer exist. In these centers, we have found little or no difference in training required compared to Western sites.
As China emerges as a major contributor to clinical trials, software has been developed to meet the requirements of Chinese sites. Local language availability was previously a broader challenge, not one just limited to China. But over recent years we have seen translation tools developed that allow eCRFs switch text to a variety of languages. Whether this be Spanish, German or indeed Mandarin, this has vastly increased the number of sites that are able to participate in EDC trials.
The variety of EDC providers now available also mean there is greater competition in the field, and hence a range of tools with broadening functionality are continuously emerging. These software now allow data from different sources, or for different tasks, to be centrally held, with pre-defined integrations. For example, randomisation modules (IWRS) can sit alongside drug supply management tool, endpoint adjudication hinges upon robust data being accessible remotely in a timely manner, electronic Patient Reported Outcomes (ePRO) are increasingly being utilized, risk based monitoring relies on near real time data for success, and lab data is now routinely sent electronically from a central laboratory. And yet, despite the increasing functionality, we are seeing a variety of competitive licensing options being offered, reducing the cost hurdle for EDC adoption. Robust EDC solutions are now accessible to smaller budgets and even Investigator initiated studies.
The increasing exposure to EDC technology will increase the number of sites who are able to participate in regional and global trials, and in a cyclical effect, dramatically increase in the number of such trials conducted in China. This rising familiarity and experience, not just at site level but across service providers and sponsors, is essential in a clinical trial environment that is fast becoming electronic. There is no doubt that China will be part of this shift, and it is imperative we put in place highly experienced resources in China to support it.