It's all about

flexible solutions – capturing, analyzing and reporting patient-related data traditionally, by paper and fax, or electronically, by EDC and PDA. In every case we integrate the information into a clean, compatible and fully CDISC-compliant database to facilitate regulatory submission and acceptance. Which means you can rely on Quintiles for consistently faster, more accurate
                                                                                    results.

Quintiles added 71 new EDC-based trials in 2004, and we have reached the critical milestone of reducing the cost to below that of paper-based equivalents.

Data management, as you like it.

We have the resources and experience to be totally flexible about data capture methods and management, from building the data structure through database lock. We can easily accommodate traditional paper-based documents in Oracle® Clinical or Clintrial™, as well as multiple EDC systems. 

Smarter outsourcing means lower costs, faster start-up and more efficient workflow.

Quintiles has developed a new preferred-provider data management partnering model that consistently saves money and improves efficiency, while maintaining Quintiles' high standards of quality. Combining multiple studies under a single contract eliminates up-front delays and reduces administrative costs by 20 to 30%.

Quintiles adds value to these partnerships through functional outsourcing – handling the entire data management function. This ensures consistency across multiple trials, because Quintiles understands your requirements, SOPs and IT infrastructure. It increases resource utilization and reduces the management time that would normally be required to initiate and oversee each project individually.

And it enables the whole data management process to move more efficiently, because no time is required for a learning curve. With the same teams working across multiple studies, separate training for each project is virtually eliminated. As a result, timelines that used to take months can be reduced to weeks or even days.

An introduction to CDISC – and why it's important.

The Clinical Data Interchange Standards Consortium (CDISC) recently established standards on how data should be collected and submitted to agencies that approve new medicines. Quintiles is a certified CDISC Registered Solutions Provider and can ensure that your data submissions are in full compliance – in both content and format – with the standards.

A groundswell: Making the transition to Electronic Data Capture (EDC).

CDISC is an electronic data submission platform, and Quintiles is a strong advocate for a transition (sooner rather than later) to end-to-end electronic data management, including electronic data capture. The paper bottleneck is a substantial one: paper forms loaded with data that have to be converted to a digital format – and painstakingly reviewed for accuracy – before they can be distributed or analyzed.

Electronic data capture seems like an obvious solution, but success in EDC is only partly due to technology, and largely due to service, reassurance and proper training of the people who use it daily. By providing a range of services that make EDC effective, Quintiles helps you develop more accurate data sooner, analyze it earlier and take action on real-time data trends rather than ancient history.

The comfort factor: Unparalleled experience.

Our data management experience covers projects large and small, across all phases of the product development process. We assist customers in achieving the results they need with both stand-alone data management projects and fully integrated clinical programs.

Our data managers leverage their therapeutic area expertise to design CRFs and capture the data with optimal speed and quality, and to structure a database that meets the precise requirements of the biostatisticians who transform the raw data into meaningful (and compliant) regulatory submissions. From the initial handling of case report forms to completion of the database, our global standard operating procedures ensure a degree of worldwide consistency, completeness, and accuracy that exceeds regulatory requirements.

And that's what makes the difference between a confusion of numbers and a clear interpretation of outcomes.

Data Management Services

• Phase I-IV Clinical Studies
• Small and Large Studies
• Stand-Alone Projects
• Full-Service Clinical Programs
• Flexible Data Collection and Entry Options – Using Our Systems or Yours
  • Paper
  • EDC
  • Fax
  • Voice/Phone
  • Pen/Tablet
  • PDA
• Complete Outsourcing of Data Management Functions
• Rescue Studies
• Data Warehousing
• Therapeutic Expertise
• Data Management Consulting

For a more efficient development program, consider combining Quintiles' data management services with Quintiles' clinical operations, regulatory, medical, clinical laboratory, biostatistics, clinical supplies, and quality assurance services.

Contact Us:

In the US: 877 988 2100
In Europe: +44 (0) 1344 708000
Email: dm@quintiles.com