The expanding role of Real-world Evidence in early clinical development

News

17 Nov 2021

The expanding role of Real-world Evidence in early clinical development

Why collecting Real World Data is important to optimize clinical trials and get new medical product approved?  In clinical development, the traditional approach to demonstrate efficacy and safety of a new drug has always been in performing the traditional Randomized Clinical Trials (RCT) programs since this is considered by Regulatory Agencies as the best compromise to get sufficient, well-structured data from a subgroup of the […]

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Virtual Clinical Trials – Unifying Trials from Patient Engagement Through Study Closeout

News

17 Aug 2021

Virtual Clinical Trials – Unifying Trials from Patient Engagement Through Study Closeout

Are you interested in Virtual Trials? You have heard about it, but not sure whether this approach is the most appropriate for you? You want to know how to increase patient compliance and data quality? We are happy to announce our upcoming webinar at XTalks on Monday, September 20, 2021, 10am EDT (NA) / 3pm […]

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Discrete Choice Experiment: How to Run a Preference Study with the DCE Methodology

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8 Jun 2021

Discrete Choice Experiment: How to Run a Preference Study with the DCE Methodology

Are you interested in Preference studies? You have heard about DCE, but not sure whether this approach is the most appropriate for you? You want to know how to define such a project and understand outcomes you would expect from? We are happy to announce our upcoming webinar at XTalks on Friday, June 25, 2021, […]

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How to Select CTMS that will Positively Impact the Quality of your Study

News

12 Apr 2021

How to Select CTMS that will Positively Impact the Quality of your Study

The global usage of the clinical trial management system (CTMS) is increasing thanks to its outcome’s significance and efficiency. It lessens the cost of the amount invested In managing clinical trials. Reports indicate that the CTMS market’s valuation will grow from $570 million in 2019 to a projected rate of $1.4 billion by 2026. Major […]

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Health Authority Platforms for Clinical Trial Information

News

20 Jan 2021

Health Authority Platforms for Clinical Trial Information

The European Medicines Agency updated the Clinical Trial Regulation (Regulation EU No. 536/2014) to ensure that clinical trials are executed in the subjects’ best interest. Although the regulation went into effect on 16 June 2014, its application depends on the release of the EU clinical trials portal “Clinical Trials Information System (CTIS).” Together with other […]

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Join our Free Webinar on January 28, 2021

News

15 Jan 2021

Join our Free Webinar on January 28, 2021

11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central) DEMYSTIFYING CLINICAL SYSTEMS INTEGRATION Clinical trials have become extremely complex, as have clinical systems. Their integration becomes a priority to maintain consistency and to gain efficiency in data collection. Often, mid-size pharma and biotech companies believe that such integration might be beyond their reach […]

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Important Regulatory Pathways for Accelerated Approval

News

5 Oct 2020

Important Regulatory Pathways for Accelerated Approval

– Takes about 6 minutes to read this topic – The U.S. FDA has implemented various programs that help to deliver safe and effective therapies to patients in need.These programs cover a broad spectrum of topics and provide additional pathways and/or support for innovative science. In this blog, we’ll discuss several important and well-known programs and their […]

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Why it’s best to do eCRF design for clinical trials

News

9 Sep 2020

Why it’s best to do eCRF design for clinical trials

– Takes 10 minutes to read this topic – What’s the background on eCRFs? Electronic case report forms (eCRFs) are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products. For a study to be successful, data collected must be correct and complete. To be correct […]

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Adaptive Trial Design

News

26 Aug 2020

Adaptive Trial Design

– Takes about 4 minutes to read this topic – As long as their trials are well-designed and based on prior data, safeguard participants, and meet all current federal standards, drug developers have wide latitude in clinical trial design. Though clinical trials still largely follow traditional designs, some notable advances made over the last two decades are having […]

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From Tragedy Came Progress

News

8 Jul 2020

From Tragedy Came Progress

– Takes 6 minutes to read this topic – In the early 20th century, the scientific community advocated for the use of “well-controlled” therapeutic drug trials. These relied on laboratory analysis followed by clinical testing in animals and humans. But the development of these drug trials was helped along by some of the darkest episodes in the history of […]

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The Future of Clinical Research: Big Data and Precision Medicine

News

14 Jun 2020

The Future of Clinical Research: Big Data and Precision Medicine

– Takes about 10 minutes to read this topic – Change is the only constant in clinical research. New data sources, new data types, and new trial designs that open up new opportunities for data analysis are emerging. These changes reflect a movement in clinical research toward the development of more targeted therapies. As we […]

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The History of Clinical Trials: A Drive for Better and Safe Medicines

News

21 Mar 2020

The History of Clinical Trials: A Drive for Better and Safe Medicines

– Takes about 10 minutes to read this topic – Clinical trials are crucial in advancing human health and the practice of medicine. From early drug discovery to late stage clinical studies and post approval, the clinical trial process continues to evolve. This evolution of clinical trials offers insight into current regulations, trial designs and […]

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