Data Management

Our highly experienced Data Management team have a wealth of industry experience from contract research organizations, to biotech, medical device and pharmaceutical companies.

Data Management

data management

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 organizations, biotech, medical device and pharmaceutical companies. They have vast experience working across a range of therapeutic areas and studies.

The data management team focuses 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 with DM located in Australia, India and China, with our US data management team enabling us to operate globally.

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. The fully validated and 21 CFR Part 11 compliant systems George Clinical use include Medidata RAVE, IBM Clinical Development, OmniComm’s TrialMaster and Medrio.

George Clinical’s data management services include:

  • Protocol review and Design of CRF
  • Design, testing, validation and maintenance of 21 CFR Part 11 databases
  • 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)

Integrated eSystems

Fully integrated eSystems are essential to simplifying the overall clinical trial process. George Clinical has a number of preferred EDC platforms: Medidata RAVE, IBM Clinical Development, TrialMaster and Medrio. 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.

IBM Clinical Development (Formally Merge eClinical OS)

IBM Clinical Development is a fully integrated EDC system that provides an easy-to-build system with competitive data point fees and minimal infrastructure requirements. IBM Clinical Development 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 and complexity of your study or organization. IBM Clinical Development also incorporates additional functionality that may be required in conduction your clinical trial, such as Drug Inventory Management, Endpoint Adjudication workflows and a Lab Normals tool. Working from a single, secure platform, you can build your study and manage randomization to endpoint adjudication and archiving results.

Medrio

Medrio is also a fully integrated EDC system that offers reduced costs and time savings compared to traditional EDCs. It is a simple, easy-to-build system with low data point fees and requiring minimal infrastructure. 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 an EDC to meet a wider range of customer needs.

Medidata RAVE

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. Medidata RAVE is committed to advancing the competitive and scientific goals of their life sciences customers worldwide. Their 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 to execution, management and reporting.

IBM Clinical Development
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Data management delivers customized solutions through a variety of database options, tailored for each study and sponsor.

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January 17 - 18th, 2019

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George Clinical

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Profits from George Clinical support the work of The George Institute for Global Health.

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