The PHUSE Safety Analytics working group is conducting this survey to better understand the approach to safety planning, signal detection and signal evaluation in early clinical development across pharmaceutical companies. Your insights can help shape industry-wide best practices for early clinical safety assessment.
The results will help define current practices and inform a white paper with recommendations, most likely leading to publication, on processes for safety assessment in Phase 1 and Phase 2 studies. This white paper will be developed by the PrOACTS (Process for Ongoing Assessment of Clinical Trial Safety in early clinical development) project team within PHUSE Safety Analytics and will be publicly available upon completion. As a courtesy, we will share high level survey results with respondents before the white paper is released.
We ask that one representative per company serve as the lead in completing and submitting the survey. Ideally, responses should be answered leveraging the knowledge of relevant company personnel, in particular a clinical scientist and a statistician who are involved in early development clinical trial safety assessments (Phase 1 and 2 studies). Submitted surveys will remain anonymous as to company or individual responder identification.
If more than one representative from a company responds, the survey link will be sent to the first responder. However, we will notify both company responders to afford them the opportunity to collaborate. The survey is available via a Microsoft Office Form or Google Doc and consists of mainly multiple choice questions and should take approximately 20 minutes to complete.
We greatly appreciate your consideration in agreeing to be a survey participant. If you agree to participate, please contact Barbara, Greg or Mac (contact details below) with your acceptance, and we will forward the survey to you in both formats (or the one you prefer).
Barbara Hendrickson - bhendric@bsd.uchicago.edu
Greg Ball - greg.ball@asapprocess.co
Mac Gordon - rgordon2@its.jnj.com
Note: PHUSE is an independent, not-for-profit organization run by a worldwide team of volunteers. We are a global community and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers, data scientists and eClinical IT professionals.
https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26804326/Safety+Analytics
Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
A 1 hour online event, that includes a presentation followed by Q&A.
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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