news roundup
The acquisition of the medical affairs outsourcing company positions PAREXEL to address the growing commercialization-outsourcing market for sponsors seeking to optimize awareness and understanding of their products in development or already on the market.
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CTA: Dive into Almac Clinical University now!
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MediStat, a data management and biostatistics organization headquartered in Tel Aviv, has partnered with OmniComm Systems to use its TrialMaster EDC product for its clients' trial purposes.
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Are Local IRBs Really Necessary?
Live Webinar: Tuesday, February 28 at 1:00pm EST
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A recent NEJM article highlights the important challenges small biopharma faces in designing and implementing clinical development programs.
The FDA released an analysis of 22 development programs where promising Phase II clinical trial data was not confirmed in larger Phase III trials for certain drugs, vaccines and medical devices. It documents the value of large, confirmatory, Phase III studies in ensuring the safety and efficacy of experimental medical products.
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Blog Posts
The clinical trials industry needs a Travelocity for matching patients to trials.
A questionnaire circulated by EU officials to understand HTA and regulatory roles has produced widely varying views on everything from what should be coordinated to who should be in charge.
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Articles
This article contains questions that every sponsor should ask their CRO to ensure they comply with the new guidelines, which were finalized in November 2016.
Data and interviews from Tufts CSDD show study start and site selection and activation activities are still fraught with challenges.
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