Sample Accountability Shows Stepped-Up Focus
TGAS ADVISORS® SAMPLE ACCOUNTABILITY BENCHMARK SHOWS STEPPED-UP FOCUS ON COMPLIANCE OPERATIONS
East Norriton, Penn., October 14, 2009-- Sample Accountability is one of the most closely watched areas of pharmaceutical compliance. To find out how pharmaceutical companies are managing their compliance operations in this era of stepped-up oversight, TGaS Advisors conducted an on-the-spot mini-benchmark at the recent PDMA Alliance Sharing Conference in Miami Beach. The results, drawn from interviews with 29 Sample Compliance professionals at 17 of the leading pharmaceutical companies, showed that companies are clearly paying close attention.
* While sales forces are shrinking, the anticipated budget for PDMA and training is not. The majority of respondents expect this number to stay about the same (44%) or increase (33%). The average PDMA Compliance budget for 29% of the companies in the benchmark ranged from $700,000 to $1.2 million. * Sampling via e-signature is done by 86% of those surveyed. By next year all expect to move to e-signatures. * One surprise: more than half (53%) reconcile by lot number, which is not required. Another 33% reconcile by product code and the remaining 13% use other methods. * Everyone indicated their companies have a documented significant loss threshold. On the other hand, only 46% also have a separate loss threshold due to transit. About 50%update their threshold requirements annually.
Robert Melillo, attorney and pharmaceutical compliance expert who partners with TGaS Advisors to conduct the firm’s Commercial Compliance Benchmark (CCB), developed the mini-benchmark and presented it at the PDMA Conference. “Since companies are increasingly monitored for Sampling Compliance, sales executives were eager to participate and learn how other pharmaceutical companies are handling these evolving issues,” he said. “TGaS Advisors developed the Commercial Compliance Benchmark because it is of such critical importance in today’s environment,” said Stephen E. Gerard, Managing Partner, TGaS Advisors. “In addition to Sample Compliance, TGaS Advisors benchmarks the full range of Commercial Compliance, including such areas as the PhRMA Code, state reporting issues, Office of Inspector General (OIG) guidelines, new DDMAC rulings and other issues that impact the industry so deeply.”
About TGaS® Advisors TGaS Advisors, ranked in the top 50 among U.S. Business Products & Services companies by the Inc. 500, is the leader in benchmarking and advisory services to the pharmaceutical and biopharmaceutical industry. The TGaS Advisors roster includes nine of the top 10 and the majority of the top 50 pharmaceutical companies with operations in the U.S. market. The firm’s benchmarking and advisory services suite of solutions, PharmaStance®, provides clients with a way to measure where they stand with respect to their organizations and answers the question, “How do other pharmaceutical companies do ‘it’?”• TGaS Advisors is based in East Norriton, Pennsylvania.
Posted: October 2009
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