DaVita Clinical Research Announces New Data Management Services Capabilities

“Our ability to perform both healthy volunteer trials as well as specialty trials with fullservices will garner efficiencies and drive quality for our partners” said Amy Young, vice president and general manager at DCR. “As research trends continue to involve patient studies earlier in the trial process, the ability to have real-time access to accurate data from a single organization becomes increasingly important.”

Employing software and fully validated systems, the data management services group demonstrates DCR’s ongoing commitment to offer best-in-class development capabilities. DCR has conducted more than 90 early clinical trials in more than 1,000 patients and healthy normal volunteers since 2009, including specialty populations and first-in-human studies. DCR now operates 122beds across two Phase I units in Minneapolis, Minn. and Denver, Colo.

The data management services team will be led by Michael Kreuter, director of DCR, who is located in Denver.

“Data integrity and patient safety are critical in Phase I clinical trial work,” saidKreuter. “We are building on DCR’s solid track record in those areas with a full range of data services necessary for early clinical work.”

Features of the data services group include:

• Industry-experienced team, with expertise in good clinical data management practices

• Data management, medical writing, biostatistics and PK analysis and reporting capabilities

• Databases built using industry-leading Oracle® Clinical RDC, allowing for:
• Quality delivery throughout the data life cycle

• Cost effective management of the database

• Timely reporting and finalization of all data points

Programmed systems using guidance from CDISC, ICH and other current guides

Client standards, which can be customized and used for future studies

Delivery of final datasets in industry standards including:

• SAS©

• ASCII

• SDTM and CDISC formats

• ADaMS Datasets