Peer-Reviewed Articles

The Changing Role of the CRO and its Effect on Project Management

By Volker Hack, Denise Sackner

Market trends are driving the need for biopharma to decrease fixed costs, leading to increased outsourcing to CROs. To meet greater demand, the role and profile of Project Managers needs to continuously adapt to an ever changing clinical trial environment.

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

By Xavier Fournie, MD, Jean Siebenaler, MD, Sandra Wiederkehr, PhD

A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.

European Pediatric Informed Consent and AF: Current Status of Country Requirements

By Alexandar Cvetkovich Mutanola, Martine Dehlinger-Kremer, Erik Hamminga, Michela Masoero, Alejandra Mørk, Daria Podgórska, Sofia Romboli, Jürgen Schäfer

The Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.

FDA Inspections

According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting. Any deviations during an inspection can lead to a Form 483, leading to a lengthy process to address the problem.

These articles can help you prevent receiving a 483 by creating best practices.

Read more.

Data Analysis

Measuring the Added Time of Complicated Phase III Studies

This analysis uses a large dataset to forecast the study completion time costs of specific protocol designs and execution plans.

Best Practices in Study Feasibility

This Best Practice in Study Feasibility report covers techniques and innovations offered by sponsors and CROs for conducting analyses.

Are Clinical Trials Becoming More Global?

The globalization of clinical trials is the subject of this analysis to find if there is an increase in non-traditional sites.



IRT 2016

October 25 - 26, 2016
Philadelphia, Pennsylvania

Exploratory Clinical Development

October 26 - 27, 2016
Hotel Palace, Berlin, Germany

RBM 2016

November 03 - 04, 2016
Philadelphia, Pennsylvania

Clinical R&D Financial Tracking & Analysis Summit

November 17 - 18, 2016
Philadelphia, Pennsylvania

Cannabis-Based Therapies

November 30 - December 01, 2016
San Francisco, California


Inspecting Ali Baba's Cave of EMA Drug Data

By Peter O'Donnell

The European Medicines Agency’s new website of detailed information on products it has assessed has been launched. Thus begins a new era of open access data for European pharma industry professionals.

Trying to Get Inside EMA's New Clinical Trial Databank

By Peter O'Donnell

The European Medicines Agency has started to deliver on its promise of open access to clinical reports for new medicines authorized in the European Union. Peter O’Donnell reports on his experience accessing this database.

FDA Highlights “Flexibility” in Approving Rare Disease Therapies

By Jill Wechsler

The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development. The challenge now is to see if confirmatory trials show more benefit, or lack of efficacy.


Centralizing Your Clinical Trials Office

By David Russell

Hospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research. Adopting a centralized clinical trials office (CTO) can greatly assist in managing these changes.

CDISC Standards Key to Meeting FDA Regulations, Research Goals

By Jill Wechsler

The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically. Meanwhile, efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data are not going unnoticed.

FDA RBM Guidance is Still Misinterpreted

By Moe Alsumidaie

As biopharma companies continue to explore and experience ways in which risk-based monitoring is implemented, the process of such can be misconstrued. Peter Schiemann elaborates on some of the current issues of RBM interpretation and implementation.


Technology That Touches the Patient

What used to be segregated approaches in clinical trials—ePRO, telemedicine, mobile health, devices and wearables—now gather under the umbrella of technologies that touch the patient. And those technologies can have positive implications for costs efficiencies in clinical trials, streamlined data collection, as well as on patient compliance and retention.


Oncology Clinical Trials

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.


Cardiac Safety Assessment Update

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.



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