Peer-Reviewed Articles

Master Protocols in Oncology: A Review of the Landscape

By Bradley Smith, PhD, Kathy Giusti, MBA, Richard Hamermesh, DBA, Dixie-Lee W. Esseltine, MD

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.

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.

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).

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Data Analysis

Understanding the Investigator Usage of Individual Pharmaceutical Companies; the Pfizer Case

With Open Payments it is possible for Pfizer to better understand its own investigator usage pattern and how that pattern may differ from the practices of other pharmaceutical companies.

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 data indicate that the United States remains the central location for clinical trial activity.



Optimization of Cell and Gene Therapy Production

March 26 - 27, 2018
Washington, DC

Imaging in Clinical Trials

March 28 - 29, 2018
Philadelphia, PA

Expanded Access Programs 2018

March 28 - 29, 2018
Washington, DC


Buy a Diploma, Buy a Degree, Go to Jail

By Angela Roberts

Education falsification has more consequences than not having a degree.

Clinical Trial Educational Initiatives Can Improve

By Moe Alsumidaie

This article will analyze industry clinical trial initiatives and investigate strategies on how to improve impact on people.

The Commedia Dell'Arte of the EMA Relocation

By Peter O'Donnell

Relocating the European Medicines Agency was always going to be hard—but no-one ever expected it to degenerate into farce.


Optimal Strategies for Compliance with EMA Policy 0070 on the External Publication of Clinical Data

By Pooja Phogat

With the EU’s new General Data Protection Regulation coming into force in May this year, the impetus for life sciences firms to cement their data management strategies has increased.

BlockChain in Clinical Trials—the Ultimate Data Notary

By Artem Andrianov, PhD, Boris Kaganov, PhD

The clinical trials industry craves blockchain technology to provide data safety and authenticity.

Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment

By Jared Kohler, PhD, Angela Quigley, Tobias Guennel, PhD

Biomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.


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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