Cytel

In the fast-evolving biopharmaceutical industry, accelerating regulatory submissions is crucial for ensuring timely access to life-saving medications. In this webinar, Manish Deole and Sebastià Barceló Bauçà will explore how a metadata-driven approach can expedite statistical review and streamline programming — from SDTM mapping to report generation. Our experts will introduce Cytel’s innovative automation tools, designed to transform submission workflows by improving quality, consistency, and speed. Register here: https://hubs.ly/Q03hY1xX0 #RegulatorySubmissions #Automation #SDTM

When preparing your clinical data submission packages for regulatory authorities, it’s crucial to stay up-to-date on current guidelines. Angelo Tinazzi offers an overview of recent updates on data submission requirements to the FDA and EMA, as well as a look at new industry initiatives aimed at improving how we create clinical data packages in support of market drug approval. #CDISC Read the post: https://hubs.ly/Q03hM98X0

Last week the Cytel team was present at the Duke Industry Statistics Symposium with two great presentations from Kyle Wathen & Boaz Adler! Thank you to all present for the many great conversations and insights! See you next year! #DISS #Statistics

In our 5th installment of our East Horizon – R Code Integration series,Kyle Wathen and Valeria Mazzanti will focus on the concept of Assurance in the context of R&D investment viability. We will compare using non-informative versus informative assurance priors to evaluate the cost-effectiveness of a clinical trial, and to ensure that continued investment is justified. East Horizon’s R Integration feature will be used to adjust the way patient outcomes are simulated while accounting for uncertainty around the true treatment effect. Register here: https://hubs.ly/Q03hB2Wz0 #EastHorizon #Assurance

When multiple #patient outcomes matter, how do we capture that in a single #statistic? Krishna P. and Cyrus Mehta discuss their adaptive #trial design approach, offering a powerful new way to evaluate #therapies when multiple outcomes ranked by #clinical importance drive decision-making. Read the post: https://hubs.ly/Q03hmZKg0 #biotech #pharma #clinicaldevelopment #drugdevelopment #statistics #adaptivetrials

When working with investors, it is important to consider how your clinical development strategy and trials design align with investment priorities. Investors are interested in optimizing time, cost and the probability of success of a funded clinical development program. In this webinar, presented in collaboration with CMO Summit, Natalia Mühlemann and Ari Brettman (Blackstone) will discuss how integrating adaptive approaches, Bayesian methods, RWD, and prior knowledge into clinical development strategies can help make your clinical program more attractive and facilitate communication with investors. Register here: https://hubs.ly/Q03hmYWr0 #CMOSummit #ClinicalTrials #CostEfficiency

PBPK is revolutionizing #drug development by offering a deeper understanding of how drugs behave within the human body. David Dahlgren discusses how #PBPK enables more informed decisions, minimizes costly failures, and helps bring safe, effective treatments to patients faster. Read the post: https://hubs.ly/Q03hdjFy0

🌟 Cytel is proud to have participated in the inaugural PharmaSUG SDE India 2025 in Hyderabad, hosted by Novartis 🌟 As a Silver Sponsor, we were honored to support and contribute to this remarkable event that fosters innovation and collaboration within the life sciences community. We extend our gratitude to our colleagues Paaras Patel, Surpriya Acharya and Vikas Shokeen for their impactful presentations and poster sessions. Their interactive and well-received contributions sparked meaningful discussions and inspired many attendees. Anil Golla Raghu Kishor Koukuntla Saikirshna Arram Sreekanth Nunna Rajasekhar Bachu Shamala G. Cytel looks forward to continuing our efforts in driving progress and innovation in the industry. 🚀 Discover more on https://hubs.ly/Q03h8HgN0 #ClinicalTrials #PharmaSUG

If you're joining us at OCT Europe at the end of the month, make sure to connect with our colleague Jennifer Ellison and discover how we are empowering life science leaders to realize the full potential of their therapies! book your meeting here: https://hubs.ly/Q03gZfLR0 #OCTEurope #ClinicalTrials

Placebo controls play a crucial role in clinical trials, but designing a placebo that closely resembles the investigational drug is a complex task. Bengt Hedin discusses both designing placebos and incorporating them into clinical trials. Read the post to learn more: https://hubs.ly/Q03gJ5Dl0