Newsletter | November 12, 2020

11.12.20 -- Clinical Development In The Era Of Cloud-Computing

An Advanced Design Framework For Clinical Development In The Era Of Cloud Computing

While the number of trial designs and types have gently expanded, finding the optimal trial design for a specific context remains an elusive goal. Cloud computing has altered the process of trial design by taking familiar techniques for simulation and modeling and generating thousands of different trial designs.

Reimagining Clinical Trials In The Era Of Cloud Computing: A Conversation

The widespread use of cloud computing has altered the clinical trial design process. Whereas three or four years ago it would take a statistician perhaps two or three days to design five clinical trial designs, a well-resourced statistician can now simulate and model well over 100,000 designs in less than 30 minutes. How does this affect the process of designing clinical trials?

An Illustrative Guide To Clinical Trial Design In The Era Of Cloud Computing

The mere availability of complex innovative trial design methodologies cannot translate into higher success rates in regulatory submission or approval if the process that drug development teams use for statistical design remains unchanged. Advanced technology now enables leaders to actively facilitate process improvements.

Advanced Design Framework: Part 1 — Methods For Thorough Exploration Of Design Space

Time and design tool limitations have restricted the breadth of design exploration possible, so it has been necessary to carefully select the portion of the design space to examine for consideration. Learn how to explore hundreds of thousands of designs available to sponsors, rapidly and in real time, to improve the chances of identifying the design that optimizes for speed, success, and savings.

Advanced Design Framework: Part 2 — The Need For A Quantitative Evaluation Approach For Deciding

Has your organization ever completed the execution of a long, expensive Phase 3 clinical trial only to learn that the organization is unable to commercialize the therapy? Learn how to effectively incorporate varied perspectives to efficiently design innovative clinical trials.

Advanced Design Framework: Part 3 — Communication Techniques To Ensure Alignment On Data-Driven Clinical Trial Designs

The stakes are high in pharmaceutical development, and selection of the statistical trial design often requires several layers of approval before a team has authorization to proceed. Learn how clear articulation of the chosen design’s benefits and drawbacks can help ensure data-driven decision making that improves speed, success, and savings.