Contract Research Organisations (CROs) need highly efficient data capture and clinical data management systems to ensure their clients have access to high quality data whenever they need it. That’s why leading Chinese CRO Rundo turned to NNIT when looking for a new system that could handle both Chinese and English language data, and paper andelectronic studies. After careful analysis of Rundo’s needs, NNIT proposed a tailored solution consisting of Oracle Clinical (OC), Remote DataCapture (RDC) and Trial Management System (TMS). The system was installed and validated in just six weeks to ensureit met Rundo’s specific requirements for efficiency and CDISC standard compliance. After comprehensive training byNNIT, Rundo staff are now using the system to manage and produce data with a guaranteed error rate of less than0.03 percent.
As a leading contract research organisation, Rundo has conducted clinical studies in more than 250 clinical research centres across China and Japan. The company offers its clients the full range of clinical research services through phases 1 to 4, including strategy consultation, regulation and registration, clinical trial management, data management, biometrics, medical writing and market research. Rundo was looking for a complete data management system that was fully validated and easy to use by its 14 monitoring teams across China and Japan.
In order to meet Rundo’s extremely high standards of data management and remote data capture, the entire system had to comply with the CDISC standard and accommodate Rundo’s strict standard operating procedures (SOPs) – including double data entry. To support Rundo’s business model, the system also had to be able to handle input and output in both Chinese and English, and be fully integrated into Rundo’s current IT system so that staff had fast and simple access to information when they need it. In addition, the solution had to be able to handle both paper and electronic data capture (EDC) because many clinical trials in China still use paper.
“Although EDC has apparent advantage, in China, there is a reality that in many clinical researches, data is still recorded by paper. Therefore we need a solution catering for China’s clinical research.” – Hua Yu, Medical Affair Director of Rundo.
NNIT began by mapping Rundo’s drug development process on an as-is basis, and conducted interviews with the majorstakeholders at Rundo in order to identify operational and strategic needs. The NNIT and Rundo project team then analysed the market offerings to ascertain the best system for Rundo’s data management requirements.Taking into account Rundo’s current IT systems – as well as the company’s future requirements – the project team settledon an OC/RDC/TMS package. However, it was clear that the system still had to be tailored to suit Rundo’s specific equirements and SOPs.Once the system had been installed and validated, NNIT worked with Rundo to ensure the system met the company’sspecific requirements. NNIT created a Chinese RDC interface and helped load the required dictionaries into TMS toensure dual-language efficiency. Also, to ensure compliance with the CDISC standard, NNIT helped Rundo buildGeneral Language and Instrument Behaviour (GLIB) items, which can be used in all clinical trials to significantly save time and improve overall efficiency. NNIT also drafted a Disaster Recovery Plan to ensure all data can be recovered ifa disaster occurs – and tested the plan with Rundo’s IT department. As no system is complete without skilled users, NNIT provided a three-week training course for all end users using a virtual clinical study as a training arena.
“The training for Rundo is tailor-made which is designed after several communication meetings with customer.”- Lu Lu,
Life Science Consultancy Manager at NNIT. NNIT supplied all aspects of the training, from training slides and user guides to final tests and certificates. In addition, NNIT worked with Rundo staff to design five CRFs and over 100 finished Edit-checks. “NNIT’s training is professional, efficient and pragmatic.” – Terry Sun, Data Management & Bio-statistic Director of Rundo.
Rundo’s new data capture and clinical data management system is now used by staff across China and Japan to input,organise and retrieve essential data from clinical trials. The company’s SOPs have been fully integrated into the system’sworkflow, and the data generated has a guaranteed error rate of less than 0.03 percent.
One of the most important improvements for Rundo since implementing the new system is the ability to handle two languages as well as paper and electronic data within the same system. This enables Rundo’s clients to select the language and method of data capture needed to match the trial’s requirements. And, whatever the language or data capture method, clients know that Rundo’s processes comply with the stringent CDISC standard.
As well as delivering the system and training, NNIT is supplying Rundo with one-year of continuous technical support,as well as conducting periodical health checks for the server and database to ensure the infrastructure continues tomeet the requirements of Rundo’s business. “Comparing with before, we have achieved a big improvement on datamanagement by building up a clean, pragmatic and easy-to-handle data management system.” – Hua Yu, MedicalAffair Director of Rundo.
Rundo International Pharmaceutical Research & Development Co., Ltd. is the first CRO to be formed by two CROs fromChina and Japan. It provides complete CRO services, from strategy consultation and clinical trial management to data management and market research. Headquartered in Shanghai, the company has offices in Beijing, Tokyo and Osaka, as well as monitoring teams in 14 cities in China and Japan. Rundo has conducted studies in 30 different cities and nearly 250 clinical research centres.