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 EXPERTS ALIGNED WITH GLOBAL THERAPEUTIC EXPERIENCE

You need customized data management solutions tailored to your specific needs for any study and any sponsor. George Clinical’s data management team has industry experience across contract research organizations, biotech, medical device and pharmaceutical companies and includes certified database base builders and medical coders. Therapeutically, the team aligns with the company’s scientific leaders in our core areas of cardiology, neurology, medical devices, oncology, respiratory, endocrinology and renal and metabolic, with relevant experience in many others.

 

GLOBAL NETWORK COMBINES DATA MANAGEMENT, RESEARCH AND DISTINGUISHED THERAPEUTIC SCIENTIFIC LEADERSHIP

As one of the leading data management teams in the Asia-Pacific region with staff located in Australia, Europe, India and China as well as a USA data management team, George Clinical can truly operate across all time zones with local representation. And as a contract research organization (CRO) with offices in Asia, USA and Europe that engages some of the world’s most distinguished scientific expertise in a diverse range of therapeutic areas, we are able to leverage our scientific leadership to establish and maintain unique investigator networks.

 

RESEARCH AND LOCAL EXPERTISE ABOVE AND BEYOND CONVENTIONAL CROS

Whether you are in the commercial or not-for-profit sector, George Clinical can provide clinical research services, maximize investigator and coordinator engagement and improve performance, particularly with regard to recruitment and patient retention. Our global scientific networks allow us to partner with local clinical communities in each participating country. Study teams are complemented by in-house and locally identified scientific experts who work alongside our trial management team to support study implementation, and we have a high standing when engaging with clinicians and patient groups of all types.

 

CUSTOMIZED, COST-EFFECTIVE, INTEGRATED SOLUTIONS ACROSS THE GLOBE

George Clinical specializes in the development and maintenance of databases for a wide range of study types, from simple questionnaires to large global registration studies, which are customized to each study’s unique requirements. We can deliver the cost-effective solutions both academic and commercial customers need for epidemiology, registration and post-registration studies. Teams spread across the Asia-Pacific region, Australia, Europe, India and China with the addition of a USA team mean that you are getting a solution specific to each region with experts in local practices and customs. Our quality-by-design approach uses a risk-based methodology and adheres to SOPs for all standard clinical data management tasks ensuring consistency and quality in data management services across studies and regions.

We provide our customers with end-to-end data management services for Phase I–IV and other post-marketing commitments, as well as tailored services for academic research trials. The fully validated and 21 CFR Part 11 compliant systems George Clinical use include IBM® Clinical Development, OmniComm® TrialMaster and Medrio. See more about these fully-integrated EDC systems at georgeclinical.com.


DATA MANAGEMENT SERVICES INCLUDE:

  • Protocol review and design of CRF and attendant specifications
  • Design, testing, validation and maintenance of 21 CFR Part 11 electronic databases
  • Regular data review/cleaning/query management
  • External data reconciliation
  • Web-based randomization and IP dispensing
  • Integration with external randomization systems
  • Database administration including user Management including site staff training
  • Medical coding (MedDRA and WHO-DD)
  • Electronic patient-reported outcomes (ePRO)
  • Endpoint adjudication database design and set-up
  • Application development and integration with EDC through API’s
  • Good documentation practice
  • Disaster recovery and back up services
  • Data entry services
  • Risk-based monitoring

 

Integrated eSystems
From bespoke customer systems to preferred EDC platforms, fully integrated eSystems are essential to simplifying the overall clinical trial process. Our preferred EDC platforms include: IBM Clinical Development, OmniComm TrialMaster and Medrio. With each system we are able to leverage the API to integrate with our own Clinical Trial Management System, or other systems if and as required. Throughout the years we have worked with a number of tailored 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 conducting your clinical trial, such as Drug Inventory Management, Endpoint Adjudication workflows and a Lab Normals tool.

 

OmniComm® TrialMaster
TrialMaster is a full-featured EDC system offering a rich capability set at a mid-tier price. George Clinical has a longstanding relationship with OmniComm dating back more than six years and they remain an active platform option for us. Depending on regions of operation, the platform capabilities required for the study, and/or client preference, George Clinical’s Data Science group may recommend TrialMaster over other systems.

 

Medrio
Medrio is also a fully integrated EDC system offering 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.

 

Contact our business development team to explore how George Clinical can leverage our scientific leadership, responsive service and results-focused clinical research solutions for your organization today.

info@georgeclinical.com | +1-901-259-0888 | georgeclinical.com

George Clinical

customerservice@georgeclinical.com

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

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