In 2020, we worked hard to keep you updated on main trends of Life Sciences world. We covered a whole range of topics from risk and mitigation during COVID-19 pandemic to clinical trial design in small populations and building a robust EDC system. You can find the full list of our expert articles in the blog section of our website.
In this article we are looking at the blogs that you found the most interesting in 2020.
How to Power Clinical Trials with Internet of Things
On July 16, CROS NT’s CEO Paolo Morelli has joined a complimentary webinar organised by Avenga, a global IT and digital transformation company. This exclusive webinar was prepared for Pharmatech, Life Sciences, Pharmaceutical, Drug Discovery & Development and Healthcare companies and focused on how Internet of Things (IoT) transforms clinical trials.
In this blog we shared the highlights of Paolo’s speech – read it to learn about how IoT is used to combine disparate data, improve clinical trials through higher patient retention and reduce trial spans.
Data Management Plan: How to Write It and Key Elements in Its Development
A well written Data Management plan (DMP) should provide a quick reference to the most important aspects of study conduct. Created at the start of a study, the DMP forces complete study planning, playing a key role in ensuring efficiency and data integrity. Most companies have a DMP template as an appendix to an SOP, including generic text.
In this blog our Data Management experts share some key factors that should be considered while writing an effective DMP.
COVID-19: Proactive Action Plan
When the global COVID-19 pandemic started unfolding, our two major concerns were safety of our team and business continuity. In order to safeguard our employees’ wellbeing as well as our clients’ interests, we have taken and continue to apply and review a number of actions as a precautionary measure in our offices around the world.
The blog “COVID-19: Proactive Action Plan” lays out our proactive action plan. If you would like to learn more about how CROS NT and its sister companies are delivering better outcomes in times of crisis, we invite you to have a look at the interview with our CEO Paolo Morelli “Navigating Business in Times of COVID-19”.
Career Insights: Interview with Monica Pimazzoni, Director of Clinical Data Management
Our clinical data management team leverages extensive experience and knowledge in order to help our clients to achieve the best results. Monica Pimazzoni, data manager expert with more than 30 years of experience, has been leading the team since 2010. Last year we talked to her to find out more about her career path, current role at CROS NT and her interests outside of work.
5 Steps to Effective Integrated Summaries
Integrated summaries of safety (ISS) and efficacy (ISE) are complex documents, presenting an integrated analysis of the safety and effectiveness results from all clinical trials performed on a study drug. Data from all clinical trials are pooled together and analysed as a whole, producing combined statistical results. The FDA requires ISS and ISE reports for New Drug Applications. In Europe, similar data are required for CTD-dossier submissions.
In this blog our expert programmers and statisticians share the main steps to effective integrate summaries that will meet the needs of the company and the regulatory authorities.
Would you like to learn about our plans for 2021? We invite you to have a look at the annual letter from our CEO Paolo Morelli!