The George Clinical Data Management Team are experts in the delivery of customized data management solutions through a variety of database options, tailored for each study and sponsor.
Our highly experienced Data Management team have a wealth of industry experience from contract research organisations, to biotech, medical device and pharmaceutical companies. They have vast experience working across a range of therapeutic areas and studies.
The Data Management team focusses on the development and maintenance of databases for a range of study types, from simple questionnaires to large global registration studies. We customize our approach to a study’s needs. We deliver cost effective solutions for epidemiology, registration and post-registration studies, for academic and commercial customers. We are the leading data management team in the Asia-Pacific. Our Data Management team operates globally and has unique expertise in Australia, China, India, Japan, Korea, Hong Kong, New Zealand, the Philippines and Malaysia.
The George Clinical Data Management team offers end-to-end data management services for phase I – IV and post-marketing clinical trials, as well as tailored services for academic research trials. Our goal is to provide flexible solutions to our customers by offering a range of database options to suit study requirements. Fully validated and CFR part 11 compliant systems used include InForm and Medrio; and options for academic research trials include REDCap.
George Clinical’s Data Management Services include:
- Design, testing, validation and maintenance of 21 CFR Part 11 databases and websites
- Data cleaning and reconciliation activities
- Web based randomization
- Set up and management of EDC user accounts
- Coding of adverse events and medications
- Electronic Patient Reported Outcomes (ePRO)
Fully integrated eSystems are essential to simplifying the overall clinical trial process. George Clinical has a number of preferred EDC platforms: InForm, Medidata RAVE, Merge e-clinicalOS, Medrio and REDCap. Having a number of platform options available, allows us to tailor our data management solution to fit study and sponsor requirements. We also have a depth of experience working with a number of bespoke customer systems.
Merge eClinicalOS (eCOS)
Merge eCOS is a fully integrated EDC system that provides an easy-to-build system with competitive data point fees and minimal infrastructure requirements. eClinicalOS (eCOS) is an innovative and cost efficient platform to manage clinical research data. It’s a highly scalable clinical data management system that offers all of the support capabilities you need no matter the size of your study or organization. Working from a single, secure platform, you can build your study and manage randomization to endpoint adjudication and archiving results. eCOS sets the industry standard for a simple, straightforward user experience.
Medrio is also a fully integrated EDC system which offers much reduced cost and time savings compared to traditional EDC. It is a simple, easy-to-build system with low data point fees and requiring minimal infrastructure. More importantly, it is built in a validated environment and is fully compliant with major regulatory requirements. By using Medrio as one of our preferred systems, we can offer all the benefits of EDC to a wider range of customer needs.
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. We are committed to advancing the competitive and scientific goals of our life sciences customers worldwide: more than 700 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations. Our industry-leading technology platform, the Medidata Clinical Cloud®, is the primary technology solution powering clinical trials for 17 of the world’s top 25 global pharmaceutical companies, bringing new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting.
Data Management delivers customized solutions through a variety of database options, tailored for each study and sponsor.