Saturday, February 20, 2010

Pros and Cons to Clinical Partnerships and Metric Model Selection

In the last 5 years and most probably due to the vast number of pharma M&A, easily measured clinical conduct, operations and submission resource solutions have been lost in the chaos. For example, several pharma believe that the CEO of the company must be involved in and focused on the life cycle of the clinical trial and clinical submission. No. Many pharma use elaborate tactical and strategic sourcing plans and metric model selection processes to resource their clinical trial and clinical submission needs and requirements. No. A number of pharma fall to strategic partnerships to reduce their resourcing and outsourcing burdens. No. Many pharma tend to follow complicated collaborative schemes by applying multidimensional performance metrics for improved clinical trial and clinical submission management indices. No. Pharma companies are trying to learn how to avoid 483 observations regarding FDA oversight and resultant compliance and deviation issues. No. Bridging the gap with so many strategic partners can only provide more chaos, create vacuums, isolate people and data, reduce ease of communication.

Classic drug, device, technology development is simple when processes and procedures are clearly mapped out in detail from start to finish and resourced properly by understanding how long it takes to create a SAS program, write a clinical summary of integrated safety and efficacy, review a safety narrative, prepare a patient profile, quality-control (QC) a clinical study report, develop a global integrated database, publish a submission-ready document - only then can pharma accurately and effectively manage resource responsibilities, start, stop dates and accountability, that will lead to a successful, compliant clinical trial and clinical submission.

Keep it Simple. Follow the regulation and guidance. Don't get fooled by elegant ways to short-cut the system or quality. Do it right the first time. Keep the team hands-on, communicate clearly and often, lead the team, manage the issues. Walk the halls.

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