Clinical Monitoring Featured Articles
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Lilly’s Approach To The Clinical Trial Paradox
2/2/2014
When I sat down with Eli Lilly (NYSE: LLY) and Company’s chief medical officer and coleader of the company’s Development Center of Excellence, Timothy Garnett, it was shortly after the drugmaker’s annual investment community meeting where bankers grilled the leadership team with questions.
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Technology Considerations To Increasing Clinical Trial Efficiencies With Risk-Based Monitoring
1/31/2014
When it comes to site monitoring, pharmaceutical companies have traditionally taken a conservative approach, performing frequent on-site monitoring and 100 percent verification of all data. This practice goes beyond what’s required, says the FDA in its Guidance for Industry: Oversight of Clinical Investigations — Risk-Based Approach to Monitoring, issued in August 2013. The agency asserts that sponsors adopted current practices based on a “perception” that 100 percent source data verification (SDV) was the FDA’s preferred way to meet monitoring obligations.
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FDA Presents Regulatory Challenges For Finished Dosage Manufacturers
12/1/2013
As president of contract manufacturer Oso Biopharmaceutical Manufacturing, there are many concerns that might keep Milton Boyer awake at night. For example, he believes that, for most CMOs, every customer is always ready to leave. Therefore, manufacturers need to have a steady stream of new clients ready to fill the void. There are also cost pressures in the industry, concerns over hiring talented personnel, and internal problems that could arise and potentially derail any relationship. But when talking to Boyer, you get the feeling that no topic consumes more of his time than concern over the current regulatory environment.
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“Non-Traditional CROs” Find Solutions While Managing Costs
9/30/2013
In the 1970’s and 1980’s pharmaceutical and biotechnology companies started to outsource many of the clinical operations services to organizations that have come to be known as contract research organizations (CROs). “Traditional CROs” established themselves by hiring and training employees to manage and monitor clinical trials. The individuals selected included those preferably with a scientific background and were most often fresh out of college or nursing school. The training they received was essential as they lacked experience in a fledgling industry. Strict supervision was also required based on low levels of experience. CRAs with zero to two years of experience made up the majority of the workforce and it was difficult for Traditional CROs to find CRAs with the requisite experience to appoint to studies. Therefore, many organizations sought to have blended teams of the more experienced monitors (3 or more years), along with ‘green staff’ or very inexperienced monitors (0 to 2 years). Many of these organizations were financially successful using this approach, yet it was significantly inefficient in terms of time and client’s budget.
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Your CRO Just Acquired Another CRO – Now What?
7/27/2013
A year ago, Wendel Barr, CEO of CRO Synteract, was frustrated. His company was profitable, he had talented personnel, Synteract was managing a wide variety of projects, and his clients were satisfied with their level of service. Despite this success, his potential to grow the business was constrained. Synteract was a U.S.-based firm with limited presence overseas. As a result, his company often found itself forced to leave money on the table, especially as its customers moved to larger, Phase 3 trials. “It became clear to us that in order to provide the range of services our customers required, we had to have more offices in Europe, beyond our office in Prague,” he says. “If you want to be a full service provider from Phase 1 to Phase 4, you have to be global.”
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You Just Got An FDA Warning Letter – What Should You Do Next?
7/15/2013
You took your time selecting a CMO partner. You prepared a quality agreement specifying each company’s responsibilities, and you did your best to monitor the quality of the product they produced. But somehow you still managed to receive a FDA-483 (Notice of Inspectional Observations) or a warning letter. What do you do now?
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Regulatory Science Unlocks Therapeutic Innovation Worldwide
5/30/2013
Dr. Ling Su, a leading industry scientist and current head of the DIA, describes how emerging markets such as China are working with developed nations to eliminate regulatory roadblocks in clinical trials.
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Life Sciences Supply Chain Innovation Comes Full Circle
5/30/2013
CEOs are discovering the virtues of quality and efficiency in the supply chain, issues they once routinely left to their engineers and head of manufacturing.
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Contract Horror Story: Confessions Of A Rogue Contractor
5/1/2013
Call me John Doe. I am the VP of business development for XYZ Pharmaceutical Services. A year ago a customer came to me requesting a quote on a job. When we submitted our proposal and price, we were informed that one of our large competitors came in at a lower price. If we wanted the contract, we would have to beat their price. I knew producing the product in our labs would not be possible at that price. But I also knew of labs overseas that could do it at a much lower cost. So I did the unthinkable. I quoted the sponsor a lower price, told them we would produce it in our labs, and then outsourced it to Asia. The contract firm was now doing the contracting. What could possibly go wrong?
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Single-use Bioprocessing Sensor Innovation Is In Need
4/26/2013
The need for single-use bioprocessing sensors and probes are increasing as process monitoring and automation push their adoption.