PHARMACEUTICAL

CLINICAL TRIALS

CyberVision provides a number of clinical development solutions to help design and implement clinical trials, registries, and other late stage development programs. We have experience in the design and management of clinical trials and post-marketing surveillance programs of all sizes and levels of complexity.

Our professionals are dedicated to high quality, cost and time efficiency, and client satisfaction, combining the highest-level expertise with leading edge technologies. We also assess product safety and develop risk mineralization plans in addition to a range of product safety strategies.

Solutions:

• Submission management applications
• Software to organize and analyze data from clinical trials
• Applications for data integration, analysis, and reporting
• Pharmaceutical ERP software
• Pharmaceutical order management applications
• SFA (Sales Force Automation) software for pharmaceutical sales teams
• Finance and accounting automation software
• Pharmaceutical CRM software
• Pharmaceutical data and document management software

Services:

• Clinical trial design, planning and implementation (Phase I-IV)
• Data safety monitoring board (DSMB) services
• Project management
• Site contract management
• Protocol and case report form (CRF) design
• Regulatory document сollection and tracking
• Report writing
• Fully customized laboratory reports
• Clinical study monitoring
• IND writing and submission

Design:

Our experts create designs to have trials approved, while sparring time and resources.

• Proof of concept and Phase IIa dose finding trials.
• Optimized Phase II dose-response trials.
• Phase IIb or IV trials more efficient than placebo-controller versions.
• Phase II learning study with a Phase II confirming study.
• Design and analysis of covariate-adaptive trials.
• Evaluate Bayesian vs, Frequentist approach

Implementation:

We integrate our systems based on a customized approach tailored to specific adaptive trial needs.

• Logistics and supply management planning
• Integrated IVRS, IWRS, simulation tool, supply forecasting,      drug supplier, ePRO and EDC
• Install an adaptive algorithm into IVRS or IWRS
• Medical writing for regulatory submissions
• Interim DMC reports with simulation and trial data results

Technologies:

• Interactive voice response systems (IVRS)
• Electronic patent diaries
• Adaptive trial design and consulting
• Client portals
• Web-based learning management system
• Interactive web response systems (IWRS)
• Dynamic randomization
• Searchable databases: MetaHub, RaterHub, Site Database
• Electronic data capture (EDC)

HOSPITAL SERVICES

We also provide a number of services for hospitals, which allow better communication between doctors and patients, as well as between hospitals and private clinics. Our experts design programs for information exchange in a number of categories, including billing records, healthcare records, and questions and answers for patients. We utilize exchange not only through computer systems, but also through mobile broadcasts and messaging as well.

Patient Administrative Services: We provide patient management through a number of services including:

• Organization handling
• Queue management
• In/outpatient handling
• Logistics and material
• Drug ordering and distribution

Electronic Healthcare Recording:

• Clinical documentation
• Mobile documentation
• Decision support
• Speech recognition
• Document handling