Data Management Featured Articles
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eSource Implementation: Where Are We Now And Where Are We Going?
5/25/2016
Over the last several years, life science firms have cautiously moved into the eSource arena. While companies look forward to attaining the benefits of eSource, they also have concerns over potential glitches, the impact on study teams, and regulatory issues.
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As CROs Merge, How Should You Assess And Manage Your Partners?
5/20/2016
Consolidation in the life sciences industry is a fact of life. The recent merger of Quintiles and IMS Health is just the latest in a string of consolidations. Research firm ISR Reports anticipates the merger activity will continue, with large CROs adding companies with complementary services and midsized CROs attempting to quickly gain scale. For sponsors, is this a good time to reevaluate existing CRO relationships?
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BMS’ Opdivo Trials: What They Teach Us About Successful Studies
5/17/2016
It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.
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Clinical News Roundup: Industry Seeks FDA Guidance On mHealth Technologies
5/13/2016
Clinical Leader news roundup for the week of May 8, 2016, with articles on FDA guidance regarding mHealth technologies, Bitcoin improving transparency in trials, software to change the future of drug discovery, the growing use of wearables and social media in trials, and more.
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Can Exco InTouch Bring Added Value To Oracle’s InForm?
5/12/2016
Oracle and Exco InTouch announced a partnering agreement that will integrate Exco InTouch’s ePRO patient engagement platform with Oracle Health Sciences’ InForm electronic data capture (EDC) system. The combination of the two platforms is expected to deliver enhanced workflow efficiency in clinical trials. But is the partnership truly a win for both companies?
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5 Key Trends Driving Clinical Trial Innovation
5/3/2016
With the rise in emerging technologies and advancements, the pharmaceutical and life sciences industry is rapidly going through transformation, where organizations are dependent on successful drug or pharmaceutical-related launches to drive profitability and growth.
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Clinical News Roundup: FDA Rejects Evidence For Muscular Dystrophy Drug
4/28/2016
Clinical Leader news roundup for the week of April 25, 2016, with articles on the FDA rejecting a Duchenne muscular dystrophy treatment, Lilly, Merck, and Pfizer sharing patient recruitment success stories, machines making clinical trials more successful, using cannabis to treat epilepsy, metaform prolonging the effects of old age, and more.
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Can Digitizing Clinical Trials Help Reverse Eroom’s Law?
4/28/2016
Eroom’s Law models the decline in R&D efficiency of traditional pharmaceutical therapies. Basically, it explains that even with the tremendous and continued advancements in technology—processing power, storage, and bandwidth capability (Eroom is Moore spelled backwards, as in Moore’s Law)—the R&D cost to bring a new drug to market is still increasing linearly.
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Speeding Research With Data Mining Expertise
4/26/2016
According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.
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NEWS ROUNDUP: Precision Medicine And Patient Data, FDA Accuses CRO Of Data Fudging
4/22/2016
Clinical Leader news roundup for the week of April 18, 2016, with articles on precision medicine and whether it can compromise patient data, FTC help for mobile health app developers, retrospectively registered clinical trials, stem cell research and clinical trials, new patient engagement tools, and data fudging in India.