ACT

march 13/2018


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news roundup

Jamie Macdonald Appointed as the new CEO of PAREXEL

PAREXEL International Corporation announced the appointment of Jamie Macdonald as CEO effective March 15, 2018.


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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
Live Webcast: Tuesday, April 24 at 11:00am EDT
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FDA Strives to Maintain Gains in Speeding More Breakthroughs to Patients

Now the challenge to FDA and to sponsors is to maintain the high level of support for research, discovery, and regulatory flexibility underpinning these gains, writes Jill Wechsler.


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Move Your Immuno-Oncology Therapy Forward in 2018 and Beyond
Live Webcast: Thursday, April 5 at 11:00am EDT
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Communicating R&D: Pipers, Payments, and Persuasion

Peter O’Donnell looks at efforts in Europe to improve R&D communication and trust with investors and the public.


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Scientific Advice with Regulators – An Essential Tool in Early Drug Development
Live Webcast- Europe: Thursday, March 29, 2018 at 3:00pm CEST, North America: Tuesday, April 17 at 11:00am EDT
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Making Real-World Evidence Real

An expert view on how sponsors can formalize the use of real-world data and generation of real-world evidence to drive critical insights.


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Patient-Centric Complex Trial Design & Site-Less Visits: How Study Design & IRT Can Ease Patient Burdens
Live Webcast: Wednesday, March 28 at 11:00am EDT
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Managing the Placebo Problem in Chronic Pain Studies
Live Webcast: Tuesday, March 27 at 11:00am EDT
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In this edition

Making Real-World Evidence Real
Patient Engagement: Are We There Yet?
FDA Cracks Down on Incomplete Applications
Rare Diseases and Concrete Cases

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PV Research Reveals Momentum Towards Cloud and AL
Live Webcast: Thursday, March 22 at 8:00am PDT
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Events

ADF 2018 - Abuse Deterrent Formulations Summit
Optimization of Cell and Gene Therapy Production
Imaging in Clinical Trials
Bridging Clinical Research & Clinical Healthcare Conference
Search Upcoming Events

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The Benefits of a Data-driven Approach to Feasibility
Live Webcast: Tuesday, March 20 at 11:00am EDT
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Articles

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices

The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.


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Achieve Better Early Clinical Development Outcomes - Faster
Use existing global network site relationships for improved early phase quality, costs and timelines
Live Webinar: Thursday, March 15 at 11:00am EDT
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Patient Engagement: Are We There Yet?

Findings from a new ACT and SCORR Marketing survey reveal a gap in the shift to true patient-engagement in clinical trials, but overall measures do signal growth in patient-centric activities.

Blog Posts

Applying Learning Health Systems to Advance Clinical Research and Health Care

The use of Learning Health Systems in order to advance clinical research.


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Immuno-Gene Therapeutics in Hematological Cancers: How Science Drives Study Strategy
On Demand.
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FDA Cracks Down on Incomplete Applications

Under pressure to meet tight deadlines for reviewing and approving a growing volume of applications for new drugs, generics, and medical products, FDA is rejecting submissions that are incomplete or unsatisfactory right from the start.


Oncology

Rare Diseases and Concrete Cases

The rare disease community in Europe has come out fighting to defend its record—and its future—in the face of what it sees as growing threats to research.


 

Clinical Trials for Rare Diseases

This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.



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Lisa Henderson
Editor in Chief
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Todd Baker
Group Publisher
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