Introduction

Implementing a clinical data management system (CDMS) involves a multitude of decisions at all levels. Data managers face the intimidating task of getting consensus around literally thousands of issues. Data standards must be established, a thesaurus put in place, input screens created - and all the parts need to work together. It's a mountain of detail, and with each step upward the clock is ticking.

Clinical directors and vice presidents face an equally mountainous task: they need to ensure that everything possible is done to maximize benefits from the new CDMS. Decisions abound, how will the CDMS relate to legacy systems? How will redundant data in multiple systems be reconciled? What about concurrent or future initiatives such as an Electronic Data Capture (EDC) system? And above all, how does this system get deployed on time, and on budget?

With Quintegra’s CDMS, you can energize your clinical data management process. The CDMS is at the heart of your clinical research machine, the engine that drives projects to the earliest possible data lock.

Offering

The Healthcare Practice at Quintegra provides smart and innovative solutions to several leading healthcare organizations around the world. The Healthcare Practice provides a revolutionary CDMS for effective and efficient management of clinical data management process.

A CDMS will bring the efficiency of your clinical trials process to an entirely new level. That's why you've decided to go for a CDMS. Now you face several challenges: making the system work, getting it done on time, and fitting it into your company's broader technology strategy. Some of these responsibilities may require resources you just don't have available.

Quintegra offers a comprehensive CDMS for making sure software and business processes work together. We have the broad business perspective to support your company in making the big decisions that bring you the greatest benefit, and the operational and technology skills to make the myriad pieces fall smoothly into place. Most important, we have in-depth, hands-on knowledge of clinical data management processes.

Quintegra’s CDMS is a centralized clinical data management and analysis system that will assist clinical investigators in managing protocols and patient & research data as well as in integrating disparate data sources for analysis.

The components of Quintegra’s CDMS are:

	A Protocol Tracking Management System (PTMS) that supports protocol submission, approval, and monitoring of protocol review process.
	A Clinical Study Informatics System (CSIS) that provides patient data management via protocol setup for patient recruitment, screening, enrollment, dynamic form creation, data collection, monitoring, and reporting.
	A data integration module that provides data warehousing services to collect data from a variety of data sources such as external scientific databases; its scope also encompasses analytics tools that will facilitate data mining and statistical analysis of data from CDMS as well as the externalsources to support biomedical discovery and translational research.

Quintegra’s Clinical Data Management System (CDMS) Overview Schematic

The CDMS is a Web-based and platform-independent system with a back-end relational database management system. It employs a multi-tiered architecture in which each tier can be executed on separate hardware platforms. Quintegra has adopted several industry-leading frameworks to accelerate development time and improve maintainability. Core frameworks include Microsoft .NET, IBM WebSphere and ObJect-relational Bridge (OJB).

Once you have invested in Quintegra’s CDMS, you want to see payoff as quickly as possible. Quintegra has the project management capabilities to make it happen. We put teams in place, and create goals, objectives, and critical path-based timelines. You are kept informed and aware of progress and issues, while we work to be certain issues are resolved rapidly. Your company will be able to quickly move studies into a production environment. We use our understanding of business requirements to adapt your existing clinical data management process to work with system changes, or to customize the application to fit unique business process requirements.

The CDMS is only the starting point for handling the flood of clinical data for the drug development pipeline. CDMS implementation often leads to broader strategic questions about the clinical data management infrastructure. As a value-add, Quintegra has the vision and expertise in technology and the clinical drug research environment to help answer these critical questions. We look to exploit the opportunities offered by the Internet to break down data silos, using technology architecture to create a collaborative systems environment that supports new approaches to every aspect of the clinical research and marketing processes.

Quintegra’s CDMS allows for:

Faster trial design and planning processes
More efficient collection and management of both patient and trial administration data
Improved FDA compliance
Secure, centralized access to sites, trials, and programs
High accuracy data entry
Comprehensive data validation
Full electronic Audit Trail

Our understanding of data systems throughout the pharmaceutical enterprise lets us build information bridges to create new value for you from existing data resources. Quintegra’s advanced technical expertise and the CDMS solution make us the choice to assist your company complete a robust, documented CDMS implementation and integration.