We will assist throughout the entire process!
We can help to build an infrastructure that best protects your key asset
- clinical trials data - and allows you to best capitalize on that asset.
We provide technical assistance to safeguard and exploit your clinical trials systems and
processes.
QUALITY DATA IS THE MOST IMPORTANT PART, IN FACT, THE GOAL OF CLINICAL TRIALS.
We also provide Year 2000 assessment services to insure a seamless
transition into the new millennium.
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Business Process Re-engineering &
Management
We will structure the process and develop a customized, functional plan for addressing
your clinical trials requirements. We can offer valuable aid at every step of the process
including definition of objectives and requirements, business process re-engineering,
workflw optimization, software/hardware selection, evaluation of staffing requirements,
fact-finding reviews, analysis and reporting, CANDA preparation, remote data entry,
standardization (forms, reports, procedures) and product selection, implementation and
integration.
We can assist you in developing process maps which minimize elapsed time and resource
requirements for critical functions by utilizing management planning techniques and tools.
We can manage the process by acting as coordinators and facilitators.
We can assist you in regaining control of your data!
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Strategic Planning & Technology
Assessment
This service will identify the technologies and platforms required to address clinical
trial's management requirements. We can also assist in the selection of products, their
customization, integration and implementation to meet your technological requirements. We
will also develop an architecture for imaging, document management, data capture and
storage mediums as well as workflow management. This service will also provide assistance
in configuration planning and network design.
As part of this service, the consideration of products and requirements including Clinical
Trial Management Systems and Clinical Trial Database Management Systems will be addressed.
We can support this effort by bringing together a team consisting of vendors, in-house
staff, and our own technology staff.
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Resource Integration
We will act as the coordinators and integrators of the diverse skills needed to fulfill
project requirements. These staff resources include CRAs, clinicians, data management
personnel, statisticians, data processing staff, corporate management, users, forms
designers and ancillary support staff.
This service will provide procedural as well as technical solutions for integrating
disparate products. Requirements definitions will be achieved in conjunction with in-house
staff. We will act as facilitators documenting procedures and identifying
hardware/software required to meet your needs. We will also coordinate with vendors and
act as agent where necessary to integrate products and services.
We can convert diversity into synergy!
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Workflow Optimization
Standardization is the key to simplifying your workflow. The development of standard
processes will facilitate protocol development, CRF design and on-going monitoring,
cleaning and analysis and reporting of clinical trial data. We can assist you in the
development of SOPs, Case Report Forms and processes for clinical scientists, monitors and
data management personnel to optimize workflow and reduce the drug-to-market time.
We can create and implement a framework that will improve and enhance your clinical trial
process.
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Technical Support
We can supply required technical assistance at any level of the process ranging from data
capture, report generation, hardware/software integration and database support through
development of a fully functional CANDA.
We can work with your staff and supply support personnel on an as needed basis to complete
the work.
We can support this effort with our team of programmers, network planners, data base
personnel and systems analysts.
| Statistical Analysis and Planning | |
| Data listings, patient profiles, summaries and graphics | |
| SAS Systems Development and Programming | |
| Creation of Analysis Datasets from Oracle Databases |