Peer-Reviewed Articles

How Social Media is Transforming Pharma and Healthcare

By Nimita Limaye, PhD, Awani Saraogi

Outlining the growing attention and pursuits around social media in adverse event reporting and advancing patient-centric initiatives in clinical trials.   

Models of Engagement: Patients as Partners in Clinical Research

By Lindsay Singler, Patty McAdams, Gina Uhlenbrauck, Kirk Jernigan, Julie Schulman

Highlighting three distinct patient partnership models to help researchers evaluate which methods of engagement could work best for their clinical programs.

Enrollment Cycle Times Can and Should Be Optimized

By Valerie Legagneur, Jonathan Peachey, Karen Correa, PhD, Gen Li, PhD

Case study shows that site activation is a key driver in determining patient enrollment cycle time, which can be minimized by identifying the "sweet spot" of sites to deploy for a clinical trial.

Comply with ICH E6 (R2)

The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
 

The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
 

Read more.

Data Analysis

Investigator Detail in Open Payments

With Open Payments US investigator names and experience will become public knowledge.

The US and the Location of Clinical Sites

More recent ClinicalTrials.gov data indicate that the United States remains the central location for clinical trial activity.

Non-Commercial Clinical Trial: An Underappreciated Source of Clinical Investigators

With the pharmaceutical industry looking for new investigators, a non-commercial clinical trial has become an under appreciated source.

ACT TV

Events

Clinical Trial Budgeting & Forecasting

February 22, 2018
Philadelphia, Pennsylvania

EU Clinical Trial Regulation Summit

March 06 - 07, 2018
Brussels, Belgium

ADF 2018 - Abuse Deterrent Formulations Summit

March 13 - 14, 2018
Silver Springs, MD

Blogs

Trump Budget Boosts FDA, Squeezes Resources for NIH and Healthcare

By Jill Wechsler

FDA funding increased under Trump's budget for the 2019 fiscal year while resource reductions take place for NIH.

Clinical Trial Update from CROWN Congress

By Moe Alsumidaie

During the CROWN congress, there was discussion on CRO acquisition and consolidation, growing interest in the use of Blockchain technology in clinical trials, and new patient engagement methodologies.

More Streamlined Clinical Research Arises from Collaborative Effort

By Jill Wechsler

The 10th anniversary of the Clinical Trials Transformative Initiative provided an opportunity for FDA officials to join with study sponsors and research experts to examine the policy achievements and plans for future efforts of improving clinical trials.

Noteworthy

Molasses in Study Startup Efficiencies

By Craig Morgan

Numerous factors can adversely impact study startup and its efficiency, in an industry plagued by rising development costs and increasing complexities.

What Pharma Companies Need to Know about FDA's New Draft IVD Guidance

By Kathleen Sanzo, Michele L. Buenafe

The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.

Value of Virtual Care Technology in Clinical Trials

By Lee Horner

Virtual care technology is emerging as a valuable tool for clinical trials, helping to improve recruiting and strengthen retention while optimizing resources for the overall study.

eBooks

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.

View all eBooks

 

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