A full-service Contract Research Organisation (CRO), Choice Pharma is one of the fastest-growing CROs in the Asia-Pacific region. But as patient numbers increased, Choice Pharma realised that it needed to manage clinical trials more effectively in order to consolidate its success. The company turned to NNIT for help.NNIT analysed Choice Pharma’s operational and strategic pains and delivered reports for the client’s program execution,focus area and budget plan. NNIT then provided a full validation package and training courses to support Choice Pharma’s globalised clinical trials in compliance with CDISC standard. With CDISC (CDASH, SDTM) requirements fulfilled, Choice Pharma is now well on the way to achieving its targets in AsiaPacific. Reusable resources are synchronised in a Global Library and staff across the region have immediate access to data when they need it.
Fast growth presented Choice Pharma with a challenge. Patient numbers rose from 4,500 to 26,000 in just one year,and the company needed a data management system that could cope with the sharp increase in data volume from clinical trials. In particular, the company wanted to develop a solution that would enable it to utilise historical information to improve clinical development programmes, support marketing and help answer questions from the authorities. The solution also had to be flexible enough to support the use of data across functional areas in a global organisation.In addition, Choice Pharma needed to identify and implement prerequisites in its management systems.
“There are certainly many benefits from conducting clinical trials in Asia,” explains Chris Wang, Managing Director at Choice Pharma, “but understanding these advantages demands uncompromising standards for data management.”
NNIT used its industry experience to map out Choice Pharma’s complete drug development process on an as-is level.The NNIT team then analysed Choice Pharma’s operational and strategic pains and produced reports on programmeexecution, focus areas and budgeting.
Choice Pharma had already implemented Oracle Clinical, an integrated Clinical Data Management (CDM) and Remote DataCapture (RDC) application. However, the system needed to be validated. NNIT provided a full validation package,including training courses, to ensure the company’s globalised clinical trials comply with the CDISC standard.The LSH-pre-oriented solution ensures Choice Pharma has access to accurate and timely information, while the integratedclinical data environment enables Choice Pharma to make better-informed decisions.Henry Liu, NNIT’s Project Manager, explains:
“All data is automatically standardised to international standards. This is a great benefit. It means that the data is now consolidated and available for crossstudy analysis – and the client can quickly answer queries from regulatory bodies.”
Thanks to its understanding of pharmaceutical standards and processes, NNIT was able to develop a solution thatenables Choice Pharma to increase its return on investment. The easy-to-use and scalable system makes managingclinical data simpler and reduces the amount of time Choice Pharma spends on managing clinical trial documents.
By ensuring all trials data is managed to the CDISC standard, Choice Pharma is far better placed to achieve its globalisation targets. Also, as all re-usable resources are synchronised in a Global Library, the company can capture and track archives with minimum effort across its locations worldwide.
In addition, the solution provides very specific benefits for staff on a daily basis. This includes:
• Reducing the frequency of monitoring visits• Reducing queries and discrepancies• Increasing monitoring efficiency• Enabling real-time data capture• Reducing protocol violations• Providing consistency of source documentation across all sites• Providing seamless transmission to backend data systems• Maintaining the familiar look and feel of paper• Allowing more subjects to be processed per day• Providing automatic calculations for data points such as BMI• Eliminating the majority of data entry errors and discrepancies• Reducing the invalid enrolment of participants• Establishing an HIPAA and 21 CFR Part 11 compliant audit trail• Minimising time lost to training and troubleshooting problems• Freeing sites from having to develop their own source documentation• Providing secure and accessible storage
Choice Pharma is an international contract research organisation established in the UK in 1998. Today, the company’s expertise is focused on the management of clinical trials across Asia-Pacific. With six operational offices, Choice Pharma is one of the fastest-growing CROs in the region. And, as part of ChoiceOne group, Choice Pharma also has global businesssupport and project management capabilities in the USA, the UK, Switzerland and Dubai.