/24-7PressRelease/ - MORRIS PLAINS, NJ, June 27, 2008 - Karen Massand, Managing Director of the Strategic Advisory Group at Skila, is sharing her experience regarding the challenges that clinical operations groups are facing in the life science industry in the June 2008 issue of PharmaVoice.
In the article, entitled "Keeping Pace with the Changes in Clinical Operations," several clinical operations experts are brought together to discuss the challenges they face in light of today's political and economic climate. Clinical programs in the life science industry are facing a radical change due to increasing global regulatory requirements, competition for patient enrollment, faster generic intrusion, competition for human resources, pressure to reduce massively escalating costs and most importantly, fewer approvals. More than ever, the clinical operations function must excel at working cross-functionally to optimize the trial process, including measuring performance, global team communication and managing partner relationships.
"The clinical operations group's primary role is to ensure that internal expectations for clinical studies are met regarding deliverables, milestones and budgets," say Karen Massand. "With so many stakeholders involved, there are contingent decision processes affected by changes in everything from launch sequence to labeling. A single touch point solution that houses all trial management metrics so that financial, trial status and other key measures are tracked is essential to allow clinical-trial teams to easily monitor trials and report any issues."
Companies will need to understand their clinical trials and lead investigators much better than they currently do. In the article, Karen Massand further discusses how pharmaceutical companies will need to provide greater transparency in their clinical trials which "also prevents much of the media noise questioning the legitimacy of clinical trial disclosures and 'who knew what when,' thus improving public confidence in the company and industry."
The "Keeping Pace With the Changes in Clinical Operations" article is available online at http://www.pharmavoice.com/archives/article.esiml?id=1362
About Skila
Skila is a global technology and services company specializing in knowledge and effectiveness solutions for the healthcare industry. Skila's solutions address the broad needs of global marketing, medical, executive and alliance management teams. To learn more about Skila visit our website at http://www.skila.com.
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