Sharp completes first phase of $23 million investment in its Bethlehem clinical services facility

Jan 9, 2018

Sharp – a part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has completed the first phase in the development of its new USD $23m state-of-the-art facility in Bethlehem, PA. Sharp acquired the new Bethlehem facility for $14m in 2017 and has now completed a $2.5m relocation project, transferring the company’s clinical storage and distribution services from its Phoenixville site. A second phase will see Sharp co-locate its fully integrated clinical services offering at the site when its packaging, manufacturing and analytical services move to the facility in late-2018, following a $6.4 million refit. ...

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What Clinical Teams Should Know about Changing Trial Logistics and How they will Affect Development – PART 2

Jan 4, 2018

As we shift to what has been described as “an Amazonlike culture”, sponsors want the same opportunity to track shipments in real time and to obtain real-time data that they can analyse. In her paper, Jennifer Worsfold, of Fisher Clinical Services, explains that this has led to a growing focus on new technology, including downloadable temperature monitors, and the ability to access real-time updates on the location and temperature condition of supply shipments. ...

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ProImmune introduces MutaMap high-throughput service for mutational activity maps of therapeutic proteins

Dec 12, 2017

ProImmune, a leader in services for understanding immune responses, has announced the introduction of MutaMap™, a new high-throughput assay service for understanding the impact of point mutations on protein therapeutic activity, including monoclonal antibodies. MutaMap provides a high-throughput service, with high-quality output data, to help decide which individual point mutations to pursue and enable better protein engineering decisions to be made, prior to committing a drug candidate to a clinical program. MutaMap is an in vitro assay system that explores the effect of deliberate point mutations on protein activity by substituting each of the 19 possible amino acid alternatives in ...

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Bioclinica Launches Clinical Adjudication Led by Experienced Medical Specialists and Researchers for Enhanced Safety & Efficacy in Clinical Trials

Nov 30, 2017

Bioclinica®, the world-leading provider of technology-enabled solutions for clinical research, today announces the launch of Bioclinica Clinical Adjudication, a transformational offering in which medical specialists and researchers, backed by advanced technology, lead independent Clinical Event Committee (CEC) review. The new service enables the independent adjudication of clinical events in conformance with regulatory requirements governing clinical trials within all therapeutic areas, including cardiac studies and for Major Adverse Cardiac Events (MACE) committees. Adjudication committee members located anywhere around the globe are able to access Bioclinica’s web-based system to securely and efficiently review clinical event dossiers. Built-in access control and tracking provides ...

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Symcel secures €3.6 million Horizon 2020 Phase II grant for clinical validation of customized antimicrobial susceptibility testing

Nov 21, 2017

Symcel, the company behind the revolutionary cell-based assay tool for real-time cell metabolism measurements, calScreener™, has secured €3.572 million Horizon 2020 funding to support the company’s evaluation of improved combination testing of antibiotics against extensively drug-resistant bacteria in sepsis patients. The project runs over 28 months with a consortium of internationally recognized academic and clinical key opinion leaders from Karolinska Institutet (Stockholm, Sweden), Hospital Universitario Ramón y Cajal (Madrid, Spain), Careggi University Hospital (Florence, Italy), Rigshospitalet (Copenhagen, Denmark), IHE (Lund, Sweden) and Symcel.     Antimicrobial resistance is increasing rapidly – often causing infections that are extremely difficult to treat ...

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