News

A recently released study regarding off-label prescribing in Europe has caused confusion as it lacked clarity on how the issue of how to govern off-label use going forward.

The economics and power of the cloud will drive its increasing adoption by pharma organizations for the foreseeable future as research becomes more data-intensive.

Regulators in the European Union (EU) and the U.S. have agreed to recognize inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.

Frost & Sullivan have released a whitepaper, with Asia Pacific specialist CRO Novotech, revealing that Asia is becoming an ideal destination for clinical trials.

The European Union, looking to re-invent itself in the wake of Brexit, is considering withdrawing policy in the field of public health.

PPD has announced that it has renewed its contract with the Division of Aids, National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).

Omnicomm Systems and Bio-Optronics have reached an agreement to integrate OmniComm’s TrialMaster EDC with Bio-Optronics CTMS solution for multiple facilities at a children’s health institution.

Logistics can have a direct and measurable scientific impact on development, clinical performance and commercialization success of advanced drug therapeutics.

This survey on Endpoint Adjudication evaluates how this concept is impacting study design, uncovering operational challenges and determining outcomes.

With sixty million Americans and Europeans diagnosed with one or more of 7,000 defined rare diseases, the availability of treatments has been less than expected.

The EFPIA has revealed the appointment of Nathalie Moll as its new director general.

PPD has established a Rare Disease and Pediatric Center to oversee rare disease and pediatric-related drug development activities.

Worldwide Clinical Trials has announced the creation of its new Michael F. Murphy Clinical Research Methodology Fellowship Program.

With the U.K. poised to begin the process of leaving the European Union soon, many questions remain as to the specifics of pharma regulation and the wide-ranging effects of this departure.

TrialScope announced the launch of the Trial Results Summaries Portal, developed in partnership with AstraZeneca.

ERT announced that clinical development service provider, Premier Research, has selected ERT’s Trial Oversight suite as its trial management solution.

The Belgium-based EURORDIS symposium on rare diseases set out to realize dreams of accessible treatment for all, but the first day left much to be desired for this achievement.

Justin Stark, Head and Director of Risk-based Monitoring and Standards are UCB discusses advancements in RBM and TransCelerate’s Quantitative Metrics Toolkit.

PPD has entered into a collaboration with drug and medical device contract clinical development services provider Frenova Renal Research.

The TMF Reference Model has released a survey for industry professionals designed to provide insight for both paper and electronic trial document management.

INC Research announced the expansion of its Functional Service Provider (FSP) service offering