Clinical trial Archives

News and Trends 8 Feb 2022

Reforms of EU Clinical Trial Regulations Bring Cautious Optimism

The EU’s clinical trial regulations received a major overhaul at the end of January 2022 to make trials easier to run across EU member states. It may bring some short-term chaos, industry insiders say, but down the road it is likely to pay off. At the start of February, the EU’s new Clinical Trials Regulation […]

February 8, 2022 - 5 minutesmins - By Victor Kotsev

biostatistics, biostatistician, clinical trial management

Why Biostatisticians are Essential for Successful Clinical Trial Management

The role of biostatisticians goes far beyond analyzing data at the end of a clinical study. Instead, they should be involved in clinical trial management right from the start to maximize the chances for a new drug’s market approval. Biostatisticians in clinical trial management have a long to-do list. They advise on study design, calculate […]

January 4, 2022 - 5 minutesmins - By Ute Boronowsky

clinical trial, robotic automation, robot hand, lab automation

Streamlining Clinical Trial Execution with Robotic Process Automation

Conducting clinical trials on time ensures that innovative treatments can reach patients in need. In the face of logistical challenges caused by the Covid-19 pandemic, the clinical trial sector has faced major pressure to come up with innovative solutions to streamline processes and continue running trials. One such solution is robotic process automation (RPA), which […]

December 15, 2021 - 6 minutesmins - By Sudha Sundaram

Opinion 10 Nov 2021

Automation Can Solve Diversity Issues in Clinical Trial Recruitment

How can we make clinical trial recruitment more reflective of the real world? Technology is coming to the rescue. The quest for diversity in clinical trials goes to the heart of patient care. Why are some demographic groups over-represented in studies when others are more difficult to recruit? Studies that fail to reflect patient demographics […]

November 10, 2021 - 6 minutesmins - By External Contributor

News and Trends 26 Oct 2021

Valneva’s Inactivated Covid-19 Vaccine Aces Phase III Trial

Last week, the French vaccine maker Valneva announced promising phase III trial results of its inactivated Covid-19 vaccine: a well-established technology that could confer broader immunity to the virus than shots currently on the market. Valneva’s vaccine candidate consists of a killed or ‘inactivated’ version of SARS-CoV-2, the virus responsible for Covid-19. The vaccine was […]

October 26, 2021 - 5 minutesmins - By Victor Kotsev

News and Trends 8 Sep 2021

As J&J Vaccine Fails Phase II, the Quest for an HIV Vaccine Continues

Johnson & Johnson became the latest company to have a failed vaccine trial against HIV last week. While it was a great disappointment to many, efforts continue in this space, helped by recent Covid-19 vaccine advances. HIV has been around for decades. While antiretroviral treatments have improved enormously, turning what was once a death sentence […]

September 8, 2021 - 5 minutesmins - By Helen Albert

News and Trends 2 Sep 2021

AC Immune’s Mixed Phase II Results Buoy Alzheimer’s Research

An Alzheimer’s disease drug developed by AC Immune and Genentech has drawn conflicting phase II results this week, raising tentative hopes for the field of treatments targeting the protein tau. For decades, the major culprit responsible for Alzheimer’s disease was suggested to be the buildup of a protein called amyloid-beta in the brain. Blocking this […]

September 2, 2021 - 5 minutesmins - By Jonathan Smith

medical cancer checkpoint inhibitor immunotherapy

News and Trends 29 Apr 2021

BMS’s Cancer Trial Showcases Potential for Checkpoint Inhibitors

Bristol Myers Squibb’s recent phase III success provided the first late-stage confirmation for a novel immune checkpoint target in nearly a decade. This could herald the next generation of checkpoint inhibitors against cancer. Last month, the antibody drug relatlimab, developed by Bristol Myers Squibb, increased the progression-free survival of melanoma patients in phase III. These […]

April 29, 2021 - 5 minutesmins - By Mark Zipkin

multiple sclerosis novartis roche ema approval

News and Trends 27 Apr 2021

EMA Approvals for Multiple Sclerosis Highlight Treatment Shortfalls

While the EU saw rapid-fire approvals in the multiple sclerosis space last month, the innovations centered mostly on improving existing approaches. Which areas of multiple sclerosis treatment need more options? At the end of March, the EMA made key decisions on three treatments for multiple sclerosis (MS), a chronic neurodegenerative disease affecting 2.5 million people […]

April 27, 2021 - 6 minutesmins - By Jonathan Smith

Data Management: Taking the Right Turn at the Clinical Trial Crossroads

The success of a new drug depends on much more than its efficacy and safety or the ingenuity of its developers. Each clinical trial has multiple decision points, and taking the wrong turn at any of these can put the entire project at risk. Data management, fully integrated into the clinical study, is a cornerstone […]

April 6, 2021 - 5 minutesmins - By Ute Boronowsky

Why Biotechs Should Invest in Good Outsourcing Management of CROs

The relationship between biotechs and their CRO partners has been long in the making. These days, a collaboration with CROs is seen as a standard in the drug development industry. However, the management of drug development partners and providers can be highly challenging for biotechs. This is where outsourcing expertise can make the difference between […]

June 8, 2020 - 8 minutesmins - By External Contributor

Expert Advice 12 Mar 2020

Five Challenges For Life Science Marketers in 2020

Developing a new drug has an estimated cost of €583M to €2.4B. Much of this spending goes towards companies, such as vendors, CROs, and CDMOs, who generate value by commercializing and industrializing innovations to improve the ways researchers study organisms and viruses in the early stages of drug development. For those of us in sales […]

March 12, 2020 - 14 minutesmins - By Mark Livingstone

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