When implementing a complex Master Protocol design in an IRT, the ability to perform seamless adaptations is an essential requirement. “Seamless” is a word that is commonly used for adaptations in Master Protocols, but does it have the same
meaning for different stakeholders (Clinical Operations, Drug Supply and Biostatistics)?
The IRT can be built to execute seamless adaptations for introducing new treatments within the randomization.
This webinar will reveal what is involved to truly implement seamless adaptations in an IRT. Through examples, Almac’s Adaptive Trial Design experts from Biostatistics and Operations will untangle the meaning of “seamless.”
- Decisions or processes required to ensure that the IRT will match your biostatistical, clinical and drug supply workflow when on-boarding new treatment arms.
- How optimizing, rather than maximizing, flexibility in the IRT software saves time and money.
- The ways in which best practices from a dedicated Biostatistics team and Adaptive Trial Design. Center of Excellence can elevate complex innovative designs within the IRT through cross functional consultancy.
- Director/Senior Management of Clinical Operations
- Director/Senior Management of Biostatistics
- Non-profit: Patient Advocacy Groups
- Director/Senior Management of Clinical Supply
Business Process Leader, Almac Clinical Technologies
Shelby Roberts is Business Process Leader at Almac Clinical Technologies, where she leads the Adaptive Trial Design Center of Excellence responsible for design and implementation of IRT technology for Master Protocols and Complex Innovative Designs. Shelby has over 19 years of IRT experience in Quality Assurance & Regulatory, Development and Operations. Shelby holds a Bachelor of Arts in Economics from Rider University and is a certified Lean Six Sigma Black Belt.
Director of Biostatistics, Almac Clinical Technologies
Jennifer Ross is Director of Biostatistics at Almac Clinical Technologies, where she leads the Biostatistics Group responsible for providing statistical consultancy on randomization methodology and IXRS® (IRT) implementation.
Jennifer has over 13 years of IRT experience and over 18 years of experience in Biostatistics. Jennifer holds a Bachelor of Arts in Psychology from LaSalle University, a Master of Science in Statistics and a Master of Philosophy in Education in Psychometrics from the University of Pennsylvania.
Almac Clinical Technologies, part of the Almac Group, offers industry leading IRT, biostatistical services, drug accountability and reconciliation tracking, and expert consultancy for pharmaceutical and biotech companies around the globe. Our professionals are dedicated to delivering high-quality Interactive Response Technology (IRT) solutions, dependable professional services, and reliable customer service. Our expertise, energy, and commitment have earned us a reputation as a trusted ally in the drug development process. Learn more at www.almacgroup.com/clinical-technologies.com.