Global News

Mallinckrodt to acquire Ocera Therapeutics

Thursday, November 2, 2017

Mallinckrodt, a global specialty pharmaceutical company, and Ocera Therapeutics have entered into an agreement under which Mallinckrodt will acquire Ocera, a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for orphan and other serious liver diseases with high unmet medical need. Ocera’s developmental product OCR-002, an ammonia scavenger, is being studied for treatment of hepatic encephalopathy, a neuropsychiatric syndrome associated with hyperammonemia, a complication of acute or chronic liver disease.

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OCT tops the list of the leading CROs in 3Q 2017

Thursday, November 2, 2017

According to the Synergy Research Group report, the most active CRO in the region were OCT, Quintiles, PSI, Synergy Research Group and IPHARMA. OCT has been working with the largest number of patients during this period. AbbVie tops the list of the leaders among foreign pharmaceutical companies, which initiated clinical trials in 3Q, while Biocad and Severnaya Zvezda were named the most active among Russian companies.

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Rethinking the Investigator’s brochure

Wednesday, November 1, 2017

The investigator’s brochure (IB) has long functioned as the main reference document for clinical trials, providing investigators with information needed to understand possible risks or adverse events (AEs) related to the investigational product and keep sites up-to-date on the study. Yet IBs are invariably lengthy, complex documents that are seldom read cover-to-cover or consulted when questions arise. While new technology has impacted many clinical research domains to improve the usability and efficiency of documents or processes, IBs remain a relic of another era.

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The Gold Rush and Monopoly Land grab in eClinical growth

Wednesday, November 1, 2017

In 2015, the global eClinical software market was forecasted to reach $6.8 billion by 2020. Recent research now doubles that estimate by 2024. The global increase in clinical trials is driving this growth, as the industry evolves from its slow paper-based methods and standalone spreadsheets toward automated, cloud-based systems to confront the oft-mentioned costs of drug development.

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Increasing participation in clinical trials among underrepresented populations

Wednesday, November 1, 2017

Reaching under-represented populations has been a challenge to clinical trial patient recruitment for years. Sponsors, CROs, recruitment vendors and sites have all struggled to find the right approach for reaching these diverse groups. While these target audiences are not necessarily small, they each have unique characteristics that can make it more difficult to engage them in the clinical trial process.

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Pay clinical trial patients back with lay language summaries

Wednesday, November 1, 2017

How do you thank someone for taking part in a clinical trial? Evidence is mounting that an effective way to thank study volunteers is to provide them with a plain-language summary of the trial results. Plain, or lay-language summaries, distill the findings of the clinical trial into a brief summary that is understandable to the general public. Various studies show that most participants want the results of their trial but they are not consistently receiving them. In addition to the results, plain-language summaries provide participants with a greater general understanding of the trial. Providing these summaries is shown to improve the overall satisfaction with trials and a higher likelihood for future clinical trial participation.

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Clinerion, Provisio partner

Tuesday, October 31, 2017

Clinerion has expanded its geographic coverage to include over 60 million patients in the U.S., via a strategic partnership with Provisio. Clinerion now has a truly global footprint for its services for clinical trial patient search and identification, and data generation for real-world evidence and market access activities.

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