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Trump FDA Chief Scott Gottlieb Isn't Pharma's BFF After All
Bloomberg Gadfly | Since rejoining the FDA in May as its leader, Scott Gottlieb has been showing the industry the free market cuts both ways.
Jan 4, 2018
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Clinerion, Greenphire, Novaseek, And More: News From December 2017
Clinical Informatics News | December was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Clinerion, Greenphire, Novaseek, and more.
Jan 3, 2018
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Top 10 Stories Of 2017: Real World Evidence, The EU’s GDPR, And More
Clinical Informatics News | As we head into 2018, we at Clinical Informatics News would like to take a moment and reflect on the achievements from this past year. In that spirit, here are the top 10 stories of 2017.
Dec 27, 2017
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It’s About Time: Conversations In The Clinical-IT Community
Clinical Informatics News | It’s About Time | Over the past few months, Norm Goldfarb has shared candid conversations with representatives from sponsors, CROs, tool-providers, and regulatory oversight groups on the pain points in clinical research and what changes are needed. Here are a few highlights from those discussions.
Dec 26, 2017
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SCOPE Preview: Patient Engagement, Real World Data, And Biomarkers In Clinical Trials
Clinical Informatics News | Clinical Informatics News will be attending the Summit for Clinical Ops Executives—SCOPE—in Orlando, Fla. from February 12-15, 2018. Here are just a few of the items from the agenda we’ve flagged so far.
Dec 21, 2017
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The First CRISPR Clinical Trial Could Begin in 2018
Futurism | For the first time ever, a CRISPR clinical trial has been applied for and will hopefully prove that the gene-editing technique truly holds potential.
Dec 19, 2017
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Year In Review: 2017 Conferences, Discussions, Awards
Clinical Informatics News | A look back at the conferences held by Cambridge Healthtech Institute, covering a wide range of content that focused on bringing members of the clinical trial and healthcare communities to come together to promote innovative technologies from clinical trials to medical informatics.
Dec 19, 2017
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Clinical Trial Contracting Challenges: Streamlining CTA Negotiations Beyond Legal Language
Clinical Informatics News Podcast | Débora Araujo of Boehringer Ingelheim is featured on this podcast from Cambridge Health Tech Institute in preparation for the SCOPE Summit for Clinical Ops Executives. Araujo discusses her expertise in clinical trial agreements and some of the daily challenges she faces in negotiations and contracts.
Dec 13, 2017
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It’s About Time: We Get Serious About Paperless Clinical Research Sites
Clinical Informatics News | It’s About Time | With the increasing cost pressures and complexities of clinical research, Ana Marquez, President of Marquez Clinical Site Partners, wants clinical research sites to move to a 100% paperless system.
Dec 12, 2017
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Bioethics International Releases Second Good Pharma Scorecard
Clinical Informatics News Brief | Bioethics International announced the second publication of its Good Pharma Scorecard, an annual index ranking large pharmaceutical companies and new drugs on their clinical trial transparency, in BMJ Open.
Dec 11, 2017
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The Way Over-The-Counter Drugs Are Regulated Is A Mess
STAT | Congress is finalizing legislation that aims to improve the system and incorporates a deal hammered out between the FDA and industry.
Dec 11, 2017
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CTI Clinical Trial, Consulting Services Announces Acquisition Of Eurotrials
Clinical Informatics News Brief | CTI Clinical Trial and Consulting Services announced the acquisition of Eurotrials, a full-service contract research organization with strong local expertise in Europe and Latin America.
Dec 8, 2017
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CRISPR Therapeutics Announces Planned European Clinical Trial
Clinical Informatics News Brief | CRISPR Therapeutics today announced the submission of a Clinical Trial Application (CTA) today for CTX001 in β-thalassemia. CTX001 is an investigational CRISPR gene-edited autologous hematopoietic stem cell therapy for patients suffering from β-thalassemia and sickle cell disease. The clinical trial will begin in 2018 in Europe.
Dec 7, 2017
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Amazon Cancels Pharmaceutical License Application In Maine
CNBC | Amazon appears to have canceled a pharmaceutical wholesaler application in the state of Maine, analysts at RBC Capital Markets pointed out Tuesday, raising further questions about the tech giant's plans to enter the pharmacy space.
Dec 6, 2017
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Zika Virus Clinical Trial Says Vaccine Safe Immune Response
MiamiHerald | A Zika vaccine developed by scientists at the National Institute of Allergy and Infectious Diseases has cleared the first phase of clinical trials. Findings were published in The Lancet, a medical journal.
Dec 5, 2017
