| PHUSE US |
2026 |
Enhancing Clinical Study Report Authoring with Generative AI: Lessons Learned on TFL Formatting and Metadata Integration in Merck's iRAP Tool |
Elisabeth Pyle |
source
presentation source |
4 |
| PHUSE US |
2025 |
Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions |
Elisabeth Pyle,
Mary N. Varughese |
source
presentation source |
8 |
| PHUSE US |
2024 |
Addressing Challenges in Structuring CDISC SDTM and ADaM Datasets to Report Adverse Events Spanning Two Treatment Periods |
|
source
presentation source |
4 |
| PHUSE US |
2024 |
Data Handling through CDISC Standards in Master Protocols: A Focus on Rescreened and Re-Enrolled Subjects |
Swathi Kotla |
source
presentation source |
7 |
| PHUSE US |
2024 |
Recruiting the Best Talent and Developing them within the Organisation |
Naveen Kommuru |
source
presentation source |
11 |
| PHUSE US |
2023 |
Retain and Grow the Talent in Statistical Programming |
|
source
presentation source |
6 |
| PHUSE US |
2022 |
Collection, Standardization, and Reporting of Adverse Events with Toxicity Changes Using CDISC Standards in Oncology Clinical Trials |
Swathi Kotla,
Elisabeth Pyle |
source
video
presentation source |
12 |
| PharmaSUG |
2021 |
Neoadjuvant and Adjuvant Oncology Clinical Trials and Considerations for Designing the Subject Level Analysis Dataset (ADSL) |
Swathi Kotla,
Elisabeth Pyle |
source |
9 |
| PHUSE US |
2020 |
Let Us Trace Back to the Beginning from the End |
Swathi Kotla |
source
presentation source |
12 |
HOME
QUICK SEARCH
AUTHORS
KEYWORDS
HELP
BUGS