What does DBL stand for?

Integration of EDC and IVR systems has many benefits, including the elimination of redundant data entry, immediate availability of data in each application, faster database lock and more rapid decision-making.

Faster data entry and faster data cleaning make clinical data available earlier for faster database lock.

Additional benefits of the PDS IVR system include: -- Reduced data entry for site personnel -- Reduced query volume for data managers -- Faster access to the IVR patient diary data for investigators -- More accurate tracking of drug shipments and supplies -- Improved clinical workflow and reduced time to database lock -- Expanded accessibility of patient registration through any system interface -- Centrally randomized patient information using IVR without re-entering eCRF data -- Automatic updating of critical information for patients randomized in the IVR system in a central database With the addition of IVR, PDS full-service EDC offerings encompass EDC, Web Reports, Data Management and integrated IVR to make running clinical trials easier and more efficient.

At the same time, Affymax expects a total of $50 million in 2010 in milestone payments from Takeda upon Phase 3 database lock ($30 million) and acceptance of the NDA ($20 million), resulting in a significantly reduced burn rate in fiscal year 2010 compared to 2009.

By joining the Medidata ASPire to Win program, we can help bring more sponsors Rave's robust and flexible capabilities to simplify data capture, improve study database build times and shrink time to database lock.

The CDQC checklist provides HGS data managers with easy access to the real-time status of studies including readiness for database lock, overall progress, backlogged tasks and clean status on a by-subject level.

However, the responsiveness of the Nextrials team and the efficiencies provided by Prism ensured that the data was clean immediately upon database lock," she said.

We experience a tremendous amount of synergy with them on our approach to clinical trials - from how we kick-off a project, to how we develop a therapeutically-focused team, to how we ensure the accuracy and speed of the database lock," stated James T.