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January 14/2020

news roundup

CRA Turnover Rates Reach New High

In 2018, CRA turnover rates in the U.S. reached a five-year high of nearly 30%, according to BDO’s 2019/2020 CRO Industry Global Compensation & Turnover Survey report. Meanwhile, compensation levels for the CRA and clinical monitoring roles have remained largely stagnant; salary increase budgets even started lagging behind general industry rates.


Veeva Vault Payments Now Available

Veeva Systems has introduced Veeva Vault Payments, add-on application for Veeva Vault CTMS manages the payment and reimbursement process to clinical research sites.


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In this edition

Finding a Path to Executing Virtual Clinical Studies
Updates on China’s Recent Regulatory Changes


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Phlexglobal Acquires Cunesoft

Phlexglobal, a provider of Trial Master File (TMF) software and services, has acquired Cunesoft (Munich, Germany), a regulatory data management software and services provider. Its Regulatory Information Management (RIM), Identification of Medicinal Products (IDMP) and Electronic Common Technical Document (eCTD) will now be offered a full suite of products.



Articles

Can Recruitment and Retention Get Any Worse?

Author Ken Getz says the current recruitment and retention environment raises the imperative and necessity to pilot and implement new study conduct models including hybrid and virtual clinical trials and those that more effectively leverage healthcare providers in clinical care settings.


Updates on China’s Recent Regulatory Changes

Recently, the National People’s Congress of China approved further revision to China’s Drug Administration Law to rationalize the infrastructure of drug administration and consolidate the remarkable outcomes obtained in recent years in China.


Events

Trial Master File Summit
Clinical Data Disclosure, Transparency and Dissemination
Patient Registries, Real World Evidence and HEOR
SCOPE Summit 2020
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Blog Posts

Cleaning Up the Drug Safety Record in Europe

Tufts CSDD and The Avoca Group recently released the results of its The European Union system for pharmacovigilance, “is operating effectively and efficiently for the promotion and protection of public health and to support innovation in pharmaceuticals such as the authorization of CAR-T cell therapies” concludes a report generated in cooperation between 28 national authorities and the EMA.


Finding a Path to Executing Virtual Clinical Studies

Author Laura Podolsky, who is General Counsel for Science 37, discusses the tension between federal and state laws that affect the conduct of virtual clinical studies.

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