IDDI Newsletter: December 2024 Edition | Season’s Greetings!

As 2024 comes to a close, we are reflecting on a year filled with achievements, growth, and meaningful contributions to the world of clinical research. In this December edition, we’re excited to share the valuable insights from our experts, and a glimpse into what’s ahead for 2025!

NEW WEBSITE

Your clinical trial data are your most valuable asset, deserving the highest standard of care.

We are very excited to launch our new website!?IDDI?is THE Regulatory Statistics & Clinical Data Science center of excellence with deep expertise in handling complex data challenges. Driven by passion to enhance the overall quality and efficiency of clinical trials, we provide tailored and efficient strategies for FDA-EMA submission, guaranteeing timely completion within budget constraints.

This new website provides a wealth of educational and scientific information on regulatoy statistics, innovative?trial design,?randomization techniques,?clinical data management,?advanced statistical methodology and much more! Visitors will have access to the presentation and the recording of past webinars, download white papers…read latest articles published in specialist journals and listen to podcasts at their leisure.

-> VISIT WWW.IDDI.COM

Dose optimization in Oncology: What is your strategy?

In January 2023, the Food and Drug Administration (FDA) released the draft guidance outlining the key principles of Project Optimus,1 whose overarching goal is to educate, innovate, and collaborate with all relevant stakeholders to move forward with a dose-finding and dose-optimization paradigm in oncology in a manner that maximizes the relationship between efficacy, safety and tolerability of novel agents. In August 2024, a final guidance was published, taking the comments by various stakeholders into account.

In the current article, we summarize key principles and the relevant literature on dose optimization in oncology, also providing our views on the implementation of Project Optimus by biotechnology and pharmaceutical sponsors.

-> DOWNLOAD WHITE PAPER

The IDDI team are excited to meet and connect with you at these upcoming conferences and discuss how we can help accelerate your clinical trials. We look forward to seeing you there!

• EUCROF Annual Conference | 2-4 February | Copenhagen, Denmark
• SCOPE Summit 2025 | 3-6 February | Orlando, FL
• ACDM Annual Conference | 2-4 March | Prague, Czech Republic
• Clinical Outsourcing Group COG UK | 4-5 March | London, UK
• Clinical Outsourcing Group COG Nordics |1-2-Apr-25 Malmo, Sweden

???Happy Holiday Season from the IDDI team

As the holiday season approaches, we want to take a moment to express our heartfelt gratitude to your continued support as we continue to advance clinical research and make an impact in patients' health. The IDDI team wishes you a wonderful holiday filled with joy, warmth, and cherished moments with your loved ones. Here’s to a bright and successful New Year ahead!

?? If you haven't done so, please subscribe to our Newsletter HERE to stay updated with our latest activities and be the first one to get exclusive #clinicaltrials insights from our experts!