ACT

OCTOBER 22/2019

news roundup

University Uses Signant Health eConsent

The National Institute for Health Research Bristol Biomedical Research Center at the University of Bristol has selected Signant Health to provide electronic informed consent support for an oncology trial. Signant Health will also collect direct feedback from patients and sites on the impact of its TrialConsent platform during a prostate cancer study.


Latest Business and People News

Updated each mid-month, this month’s moves and news include CTI Consulting, SGS, Synteract, Sharp Clinical Services, Tufts CSDD, BioIVT, Parexel, Pharm-Olam, Experic, Advanced Clinical, PHASTAR, Syneos Health, Rho, Almac Pharma Services, SCORR Marketing, ERT, Clinithink, Signant Health, Novotech, PPD, and MMS Holdings.


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Anti-Microbial Resistance and the Role of Vaccines
Europe: Thursday, November 14, 2019 at 3pm GMT | 4pm CET
North America: Thursday, November 21, 2019 at 11am EST | 10am CST | 8am PST
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In this edition

CTTI Offers Resources, Support for RWD in Trials
Tufts CSDD Shares Rare Disease R&D Insights
Critical Importance of Real-Time Access to Clinical Study Performance

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CTTI Offers Resources, Support for RWD in Trials

The Clinical Trials Transformation Initiative (CTTI) released new recommendations and resources on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential research participants. The recommendations and resources were developed by stakeholders across the clinical trials ecosystem, and include three case stdies as part of its resources.


YPrime Adds to Consulting Portfolio

YPrime has announced the expansion of its eClinical consulting portfolio to include data standards, clinical analytics and electronic clinical outcome assessment (eCOA) sciences.


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Trends and Insights for Your Oncology Trial Tuesday, November 12, 2019 at 10am EST
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Articles

Why Patient-Centric Trials are Easier Said Than Done

While the industry is significantly citing patient centricity, only a few seem to be taking real, impactful action when it comes to implementing patient-centric clinical trials. Patient-centricity shouldn’t be treated as a box to be checked off in a static, one-time act. The author explores why that is and what should it be.

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Launching Medical Devices in the Japanese Market
How to navigate regulatory and reimbursement approval
Thursday, October 31, 2019 at 11am EDT
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Tufts CSDD Shares Rare Disease R&D Insights

Ken Getz, Director of Sponsored Research at Tufts CSDD, writes that nearly every week, Tufts CSDD receives a request for benchmark data on rare disease drug development performance and economics. These benchmarks have been hard to come by, as a large percentage of companies active in this space are privately held. However, Tufts CSDD has compiled some useful benchmarks found in this article.


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Will Decentralized Clinical Trials Compound Patient and Data Quality Risks?
Tuesday, October 29, 2019 at 1pm EDT | 12pm CDT| 10am PDT
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Events

NORD Rare Disease and Breakthrough Summit, Last Day Today!
Basket & Umbrella Trials for Clinical Oncology, Starts Today!
IRT 2019, 9th Annual Interactive Response Technologies in Clinical Trials
eCOA/ePRO 2019
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GrantPlan: Create Grant Budgets with Confidence and Accuracy
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Blog Posts

IRT’s Relationship to Current Trial Issues

Often looking at clinical trials trends, there is a tendency to forget how the ecosystem must adapt to those changes. Speficially, in the area of randomization and trial supply, how patients receive their trial drugs through automation can be overlooked. Next week, CBI is holding its two-day conference to address how RTSM, IWRS, IRT can influence trends including complex trial designs, direct-to-patient or decentralized trials, study startup, blockchain and more.


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Begin with the End in Mind: The Strategic Benefit of Coordinating Site Budgeting, Contracting, & Payments
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Critical Importance of Real-Time Access to Clinical Study Performance

There are limited number of data analytics systems suited to provide sophisticated and immediate insights for companies whose data is spread far and wide across different business entities, application systems, databases, and geographies.

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How AI/ML and advanced techniques are enhancing clinical developmen
Lessons learned from use in study design, patient and site ID, safety, and risk-based monitoring
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The Quest for an Effective Partner in Pharm and Biotech

David Freeman, General Manager, Information Ventures, for Quest Diagnostics, discusses how Quest can leverage its laboratory data to be an effective partner for pharma and biotech firms with the Clinical Insights and Trials Connect capabilities.

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Successful Early Phase Drug Development of mAb Drugs
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Ask the editor

Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
TBaker@mmhgroup.com