news roundup
Chesapeake IRB Acquires Two Companies
Chesapeake IRB acquired Institutional Biosafety Corp and MaGil IRB last week. The first acquisition expands Chesapeake's services to provide comprehensive review and oversight of research using recombinant or synthetic DNA molecules, including clinical trials involving genetic engineering and gene therapy. And the second provides provides Chesapeake with additional AAHRPP-accredited review capacity.
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A New Paradigm: Cutting-edge Processes and Analytics in Site and Patient Selection
Live Webinar: Thursday, July 20 at 11:00am EDT  Register now |
Under the partnership, Elligo will make its offerings available to Consortia's network of women's health provider partners including OB-GYN and urology clinics. Working with these clinics, Elligo will provide on-demand clinical research services, technology, infrastructure, processes and on-site personnel.
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Minimal Residual Disease Detection: Key Considerations for Clinical Development in Oncology
Live Webcast: Thursday, June 29 at 11:00am EDT  Register now |
Evoke Pharma announced it will use Rho CRO to prepare and submit Evoke's planned 505(b)(2) NDA for Gimoti™—the company's nasal delivery formulation of metoclopramide for acute and recurrent diabetic gastroparesis in adult women.
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Capturing Continuous Glucose Monitoring Advantages
Live Webinar: Wednesday, June 28 at 11:00am EDT  Register now |
Exom Group announced it has launched a cloud and mobile clinical trial that will randomize about 1,200 patients from 160 clinical sites across Europe, Israel, and the U.S. to study a treatment for VTE complications in cancer patients.
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Shortening Biosimilar Development: A Case Study Integrating Early Clinical (Phase I) with late phase (Phase III) Biosimilars Development
Live Webinar: Thursday, June 27 at 11:00am EDT
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Coming to terms with Patient Centricity
Live Webinar: Tuesday, June 20 at 12:00pm EDT
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Blog Posts
Listen to DIA executives discuss current trends in drug development, and the best way to optimize your time at the annual meeting in Chicago.
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Selecting and Auditing a Technology Vendor for Biopharmaceutical Development
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CDISC has created the cloud-based Shared Health and Research Electronic library (SHARE) platform to provide multiple versions of each standard in various structured formats.
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Achieve Better Outcomes with New RBM Tech Enhancements
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Gabriel Vargas, executive medical director, Digital Health & Neuroscience Early Development Therapeutic Area Head at Amgen, discusses the use of digital wearables in a migraine study.
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Articles
Whether data contains information about you, or it's your job to protect the identities of people in the data, you need to know two things: the risk is real, and there are ways to lower it to an acceptable level.
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Emerging Biopharma and Rare Disease: Finding a Needle in a Haystack
Data-driven Patient Recruitment Solutions
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The purpose of this article is to provide a descriptive analysis of learnings from the data releases in terms of approaches to anonymization, how the EMA anonymization guidelines are being implemented by manufacturers, and how patient privacy is balanced against data utility.
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Talking the Patients' Language – the importance of effective, patient-centered engagement
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Oncology
Belgian lung-cancer patients can receive – and be reimbursed for - immunotherapy for first-line treatment. Only Austria, Luxembourg, Denmark, Finland, Sweden and Germany have reimbursed immunotherapy for first-line treatment of lung cancer.
SynteractHCR and non-profit gynecologic-oncology focused GOG Foundation have signed a three-year agreement whereby SynteractHCR will support GOG-related sponsors with any/all components of clinical trials, including clinical trial services, data management, medical and regulatory affairs, pharmacovigilance and biostatistics, and recommend GOG to sponsors it is working with.
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iCardiac has been selected to work on an early phase oncology clinical trial with a global Japanese pharma company. This study will utilize iCardiac's Rapid QT service offering, which assists trial sites in making accurate patient inclusion/exclusion decisions.
Data sharing associated with cancer trials is beginning to lead to important new scientific insights, as noted by recent articles published from the Project Data Sphere Cancer Research Platform.
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