GCTT® System, GCTT® Data Center and GCTT® Services leverages sophisticated leading edge Multi-Channel Interactive Messaging Technology (MCIMT) and clinical expertise to deliver continuous clinical trial process improvements that translate into tangible time and cost savings with increased efficiency, accuracy and quality. GCTT® System can be delivered in multiple native languages, operate continuously 24x7x365 to provide a sophisticated data collecting method to managing  progress of clinical study and optimizing the clinical drug supply chain by tracking the entire cycle of study patient and associated treatment. GCTT® Data Center provides a GCTT hosting environment and data storage facility to enable sponsor and study manager real-time global access to critical trial data, which life science companies can rely on. GCTT® Services can answer the following two (2) basic questions of clinical trial in real time:

1). For patient treatment tracking, Who takes what drug, where, when and why?
2). For trial drug supply, What drug is needed by Who, Where, When, Why?

In addition, by integrating GCTT® system with other clinical study management solutions as illustrated in the following diagram, drug sponsors and study managers are able to conduct clinical trial faster, more cost effective with high degree of quality and compliance.

1 . Leading Edge MCIMT Technology and Services

Global Clinical Trial Tracking System (GCTT® System) is a proprietary multi-channel interactive messaging technology (MCIMT) leveraging text messaging services, instant messaging services, email and fax services, interactive voice by phone and interactive web technologies. It provides the complete clinical trial patient treatment tracking and drug supply logistical support services that is critical component of global clinical research program. GCTT® System uses MCIMT technology to globally automate patient enrollment, randomization, medication assignment, just-in-time clinical supply inventory management with real time clinical study reporting dashboard.

GCTT® Data Center provides 24-hours GCTT System hosting environment and data services for study tracking and support by study coordinators, technical programmer, and clinical supply experts.  GCTT® Data Center is validated to highest standard with complete data/functional redundancy to ensure rapid disaster recovery and business continuity.

GCTT® Services offer clients end-to-end project management services to translate clinical trial protocol to User Requirement Specification, deliver and set up GCTT system in data center, provide real time user support, investigators training, clinical supply logistics for trial drug forecasting, depot and site inventory management, drug ordering from depot to depot and depot to site, global clinical trial dashboard and reporting, that meets most complex protocol design of a clinical trial and challenging project timelines.

Standard GCTT® System has built-in standard configurable GCTT functions that can meet most functional need of clinical studies on the market with the following features:

• Phone, web or wireless devices for data entry
• Integration with third party CTMS, EDC and DSMS solutions
• System delivery in 3-4 weeks of project sign-off
• Patient enrollment
• Randomization and Discontinuation
• Drug assignment
• Clinical drug supply logistic design and depot/site inventory management
• Patient unblinding capabilities
• Management of clinical medication shipments
• Study site administration
• Real-time study dashboard and reporting
• Multi-lingual services
• Validated GCTT hosting and data center with Disaster Recovery and business continuity redundancy

Custom built GCTT® System is based on Standard GCTT® System and further customized to support study protocol specific, more comprehensive and creative use of GCTT for clinical studies with flexibility, scalability and easily customizable architecture design.

2. Partnership and Benefit

GCTT® system enables partnership with clients to benefit from the following:  

• Guaranteed study blindness for speedy regulatory approval to bring the drug to market faster
• Significant clinical trial material supply cost saving
• Highest clinical data quality and compliance
• Real time global clinical study status dashboard report in your finger tips to avoid over enrollment and shorten clinical trial duration
• Expert advice to clients on how to design and implement GCTT to support study protocol
• Speed of System Set Up with Pre-built core functionality for common study technical requirements
• In-house 24x7x365 Global Technical Support
• User friendly multi-channel interface
• Fully scalable for mega studies when needed
• Experienced project management team
• Multi-lingual capabilities

1). Dynamic Patient Randomization and Dosing

GCTT® system enables the design and implementation of complex, dynamic randomization and dose titration schemes.  It also provides systems for simple randomization and subsequent assignments.  The capabilities include:

• Central Randomization
• Stratified Randomizations
• Dose Calculation
• Forced Titration Schemes
• Flexible Titrations

2). Patient Treatment Management

GCTT® system enables study sponsors and study mangers to track patient through the entire study with ready information to answer big 5W questions, i.e. Who takes What medication, When, Why and Where? What drug is needed by Who, Where, When and Why? Sites and sponsors use GCTT® system to manage key study functions including patient screening, randomization, drug supply dosing and patient discontinuation.  These activities serve as the primary data entry point for clinical supply management, data integration, visit projections, and key alert notifications. Common activities include:

• Enrollment
• Randomization
• Subsequent Assignment
• Discontinuation
• Unblinding

3). Clinical Trials Materials Management

GCTT® system enables the drug sponsors to utilize the "just-in-time" and product pooling strategy for clinical trial supplies management.  The result is more efficient and cost effective clinical trial supply strategy.

• Central and Secondary Distribution Center Management
• Lot Expiration Label Type Tracking
• Individual Unit Tracking
• Real-time Inventory Tracking
• Consignment Order Processing 
• Dynamic Dose Calculation
• Dynamic Site Inventory Management
• Return Drug Disposition