Clinical Operations Featured Articles
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Is Your CRO Charging You The Right Price?
9/5/2017
If you have a trial you need to outsource to a CRO, how do you know what is the right price you should be paying for it? If you receive RFPs with a wide variation in quotes, how do you know which one is the most realistic? If the study is delayed for some reason, what extra costs will you incur? Those are questions that a panel of experts answered at the inaugural Clinical Leader Forum.
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Mitsubishi Tanabe Tweaks Study Design For ALS Success
8/30/2017
A new treatment for adult patients with ALS, also known as Lou Gehrig’s disease, is now available to patients in the U.S. Produced by Mitsubishi Tanabe Pharma America, Inc. (MTPA),RADICAVA is the first ALS treatment to be approved by the FDA in more than 20 years. While it will not reverse the effects of ALS, a recent clinical trial found it slowed the decline in physical function of patients by 33 percent.
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Novartis: Pragmatic Clinical Trials & RWE Gain Traction
8/28/2017
In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.
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Pharma “Not Prepared” For New EU Data Protection Regulation
8/23/2017
Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.
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Is CRO Consolidation Good For Pharma?
8/15/2017
Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development?
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Do Rare Disease Cures Require A Different Partnering Paradigm?
8/14/2017
Small and large pharma companies do not operate in the same manner. According to John Gainer, CSO of Diffusion Pharmaceuticals, those operational differences are critical when it comes to new treatments making it to patients. There is a common path whereby molecules in small companies make it to market, and Gainer believes there are problems with the model.
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Clinical News Roundup: FDA Says Three-Parent Baby Technique is Illegal
8/11/2017
Clinical News Roundup for the week of August 6, 2017 with information on mitochondrial replacement technology, PRA acquiring Symphony Health, and startup monARC building patient networks for next-generation clinical trials.
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DIA Trends: Technology, Trial Design, & Regulators
8/8/2017
In his role as SVP and managing director, Americas for DIA Global, Sudip Parikh has the opportunity to look across the pharmaceutical industry at what companies are doing in regard to clinical trials. In this article, he shares his insights into what the industry can do to make trials more efficient and speed up the entire trial process.
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Clinical News Roundup: LabCorp To Acquire Chiltern
8/4/2017
Clinical News Roundup for the week of July 30, 2017 with information on LabCorp acquisition of Chiltern, merger of INC Research and inVentiv Health, FDA Reauthorization Act, Right-To-Try legislation, and more.
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Use Extension Studies To Enhance Phase 3 Data
8/3/2017
An open-label extension study is one that will lie between a double-blind, randomized controlled drug trial and FDA approval. The primary objective tends to be very different from a typical Phase 3 study, as the focus is on collecting more rigorous information on the long-term safety and tolerability of a new drug. These studies present unique challenges relating to study start-up, contracts, and selection criteria.