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In our December issue:

SURVEY SPOTLIGHT

eClinical Interplay: A Complex Picture
Lisa Henderson
In new ACT and SCORR Marketing survey, the industry shares its thoughts on digital integration and the job of managing and juggling data sources amid a plethora of software platforms springing up for clinical trials.

FEATURED

RBM Adoption Roadblocks
Penelope K. Manasco, MD
A better understanding of the barriers for pharma/biotech and CROs in adopting risk-based monitoring (RBM) for their clinical trials is needed. This report uncovers those key barriers to help determine which RBM implementation approaches may work best.

Data Governance and Access
Jim Streeter
Survey of clinical researchers, data scientists, and clinical programmers drills in on the crucial "hype-versus-reality" factor for clinical operations as it relates to data management.

Tech-Driven Endpoints
Bill Byrom, PhD
Outlining the potential of three mHealth technologies and approaches in enabling novel and more robust clinical outcome assessments.

Upending the System
David Connelly, PhD
How many truly game-changing or disruptive shifts in the conduct of clinical trials have you seen lately? Believe it or not, the right pieces are in place today for a total revamp of methods and processes for designing and managing clinical trials.

PV’s ‘Salesforce Moment’
Jim Davis
With cloud-based software dominating data systems, on-premise installations still exist and command the pharmacovigilance software market.

NEWS

Eye on Patient Advocacy: First column in our new series looks at using Facebook ads as a trial outreach tool.

Washington Report: Jill Wechsler on FDA efforts to update research policies and issue more guidances to help streamline new drug development.

EU Report: Peter O’Donnell says the EU should not rest on its laurels when it comes to pediatric research regulations in Europe.

Q&A: The importance of increased investment in staff education and experience, as well as technology, at clinical trial sites.

CLINICAL TRIAL INSIGHTS

Reactive Outsourcing Predominates
Ken Getz
New study of outsourcing model adoption and oversight effectiveness reveals heavy use of inconsistent, tactical, and reactive practices.
CLOSING THOUGHT

Patients as Partners in the API Era
Wayne Kubick
How Fast Healthcare Interoperability Resources (FHIR)-based APIs have opened the door to an entirely new world of opportunities for partnering with patients on clinical studies.
View the digital Issue
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BLOGS
FDA Maps Strategy to Broaden Use of Real-World Evidence
Sponsors Pilot New ICH E6 R2 Initiatives
BMS Operationalizes Study Connectivity
WEBCAST
Cellular Biomarkers: Predicting Clinical Trial Outcomes
On-Demand: Learn how Human Challenge studies offer researchers and drug developers the opportunity to assess vaccine efficacy in the context of T-cell subsets, cell senescence, route of inoculation, and environmental or vaccine associated priming.

If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lisa.henderson@ubm.com

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