Blogs

Regulatory Affairs Professionals Society's Executive Director, Paul Brooks, discusses the looming uncertainty about what will happen after the UK leaves the European Union as many important details remain unclear.

FDA commissioner Scott Gottlieb criticized pharmaceutical companies and clinical research organizations for being slow to adapt innovations in clinical research, claiming that the business model adopted just isn’t compatible with the kind of changes that certain innovations can enable.

A statement from Europe's drug industry and medical societies calls for adequate funding for translational research, explaining the importance, and highlighting the challenges it faces.

A look at what patient centricity in clinical research means and how it has evolved.

Insights from ExL’s 5th Clinical Trials Phase I & Phase IIA Summit on early phase trials.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

What started as an initiative called Risk-Based Monitoring several years ago is now evolving into Risk-Based Quality Management of clinical trials with a much wider impact to the pharma industry.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

Europe is gradually attempting to maximize the potential of the scattered data that, if brought together, might help improve diagnosis and treatment of Europe's 30 million rare disease patients.

Reflections explored during the mid-February EFGCP conference in Brussels on making clinical research an element of better healthcare.

Sponsors have been addressing the problem with initiatives designed to find, attract, and retain patients in clinical trials more effectively.

A review of survey results looking at bridging clinical research and clinical health care.

Database integration initiatives in the biopharmaceutical industry is now enabling clinical development departments to leverage that data for enhancing decision-making.

FDA Commissioner Scott Gottlieb supports approaches that help biomedical research “become more agile and efficient” and reduce the cost of developing therapies, including decentralized trials and how real world data (RWD) and real world evidence (RWE) to support a range of drug development goals.

Ingrid Klingmann, chair of EFGCP, speaks to Applied Clinical Trials about the efforts industry can make to change the way all stakeholders can improve clinical research.

The British government and the country's squabbling parliament are still incapable of deciding when-or even if-the UK should leave the European Union, still less how.

In this article, Moe Alsumidaie will discuss how my study teams manage monitoring reports and offer a tracking tool to assist sites with the process.

In this article, Moe Alsumidaie will identify several bottlenecks that study sites experience from the subject recruitment to the enrollment phase.

Right at the start of the year, the calls for radical change in the way that drug development is organized are emerging thick and fast in Europe.

The FDA has been working to enable greater adoption of RWE in clinical and regulatory decisions, as mandated by the 21st Century Cures Act.

In this interview, Rashieda Gluck, Senior VP, Global Clinical Operations, at Aurinia Pharmaceuticals, will discuss how patient centricity techniques are benefiting smaller biopharmaceutical companies.

The instructions of a legendary 19th recipe for jugged hare began: "First catch your hare".

From average merit increases from individual countries, to incentives per position, to retention bonuses and much more, a recent BDO report offers a robust look at an industry that has quickly eclipsed its “small company mentality” roots.

FDA prioritizes to maintain, and continue to improve, the efficient and effective drug development and review system the agency has established in recent years.

RBM is an emerging area which gives endless opportunities to explore, transform, and evolve.

DIA Europe proves to have excellent timing to learn more about the latest developments in drug development, the current status of Brexit, the plans of the National regulators and EMA, on-going discussions on pan-European HTA, and the trends for 2019.

2018 has been an exciting year in the clinical trials industry, as we have seen many changes in novel concepts, and the evolution of some concepts to the point where initiatives and pilots are crystalizing into common practice.