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.


Are you achieving the return on investment in this asset that you deserve ? Or are you being hampered by the non-integration of technical, analytic, and managerial requirements into a cohesive framework that satisfies your business needs. We have a proven track record of defining the objectives, isolating the issues, defining the appropriate process and facilitating the implementation of an on-going infrastructure that satisfies your requirements.

We will coordinate the requirements and skills of your diverse staff.

To assist you in regaining control of your critical clinical trials process, we offer the following services in business process re-engineering & management,
workflow optimization and strategic planning & technology assessments.

To assist you in data management, analysis and monitoring , we offer services in statistical analysis and reporting, resource integration and technical support.

We also provide Year 2000 assessment services to insure a seamless transition into the new millennium.






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.


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Statistical Analysis and Reporting

We employ statisticians and programmers who specialize in the analysis of clinical trials data. Our Analysis and Reporting services include:

bulletStatistical Analysis and Planning
bulletData listings, patient profiles, summaries and graphics
bulletSAS Systems Development and Programming
bulletCreation of Analysis Datasets from Oracle Databases


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2004 Strategic Resource Management Associates, Ltd.