In today’s clinical research environment, where trials are often conducted at multiple sites around the world, the effective management and analysis of data is a key issue, potentially impacting on everything from patient safety to study completion dates.
And, with global drug regulators ramping-up their scrutiny of submission dossiers, it is being increasingly recognised that any errors in reporting can significantly delay the approval process and impact on product revenues.
All of which has seen pharmaceutical industry demand for effective, third-part data management and reporting grow significantly in the last few years.
For example, in the last six months alone most of the major contract research organisation (CRO) have sought to expand their biostats offerings either, like Covance in June via appoints, or in October like Biovail by setting up dedicated units.
With its new biostatistics technology infrastructure (BTI) PPD is looking to both bolster its position and offer something different to the growing global market
The firm explained that BTI, which operates from its offices in Texas and North Carolina, US and Cambridge in the UK, allows developers to collaborate on analysis from sites worldwide.
The crucial feature, according to PPD, is that it eliminates the need to move large data sets from one server to the next which, it claimed, “reduces bandwidth utilization, increases employee productivity and creates significant time savings.”
PPD’s senior VP of biometrics said that: "This new environment allows our employees around the world to work together, accessing the same data.”
"Our investment in a global, innovative solution decreases our computer processing time and enhances our data security, giving us the ability to deliver more efficiently for our clients.”
PPD employs a staff of 300 biostatisticians and programmers worldwide who work on study design, planning and reporting from Phase I through to final regulatory submission and post approval studies.