Overcoming Bottlenecks in RECIST 1.1 Implementation for Faster Oncology Study Starts
A faster path to RECIST v1.1 readiness
In oncology trials, the RECIST 1.1 criteria continue to be the backbone of tumor response assessment, but while the criteria themselves are well established, the process of implementing them is often time-consuming.
We spoke with Perceptive’s VP of Global Services, Chandra Preyl about one of the most persistent challenges sponsors face with RECIST v1.1 implementation and how Perceptive Imaging’s standardized approach is delivering a faster path for solid tumor study start-up.
How do the RECIST 1.1 criteria contribute to lost time in oncology trials?
A major bottleneck is study startup. Even though RECIST 1.1 is a well-defined framework, sponsors still spend significant time building study-specific charters, configuring workflows, and validating systems.
This repeated customization introduces unnecessary complexity and adds time without improving scientific outcomes, ultimately slowing study momentum.
For sponsors under pressure to accelerate timelines, this can delay critical milestones before enrollment and endpoint evaluation even begin.
“By shifting from repeated customization to a pre-validated, standardized framework, Perceptive Imaging’s Core RECIST solution enables sponsors to move faster from startup to insight without compromising quality. ” – Chandra Preyl, VP of Global Services, Perceptive Imaging
How does Perceptive address this challenge?
Instead of reinventing the wheel for every study, our Core solution enables us to apply RECIST 1.1 exactly as published, using pre-validated medical logic and standardized, production-ready workflows.
This core RECIST 1.1 solution eliminates the need for repeated design and validation activities. Rather than building workflows from scratch, studies can start from a proven, ready-to-deploy model.
The impact is immediate: trials can become ‘read-ready’ in days instead of weeks.
Beyond speed, what benefits does a standardized approach to RECIST criteria 1.1 deliver?
The advantages extend well beyond faster startup:
- Faster timelines: Foundational work is not repeated, allowing studies to move forward sooner.
- Portfolio consistency: Standardized logic enables alignment across multiple studies and indications.
- Defined scope: A ready-to-use setup model establishes clear parameters early, reducing rework and timeline delays.
Importantly, startup timelines can shift to 2–3 days with a core approach versus up to 6–8 weeks for custom configurations after charter completion.
For sponsors managing large oncology portfolios or a program of studies, the ability to apply the same set up to each study delivers a level of consistency that can significantly improve cross-study comparability and operational efficiency.
Is a standardized approach always the right choice?
For most trials, yes. If RECIST 1.1 is being applied as published, particularly in early-phase studies or programs where consistency matters, a standardized approach is the most efficient starting point.
However, flexibility remains critical. Custom configurations are still available when protocols require:
- Modified progression rules
- Alternative endpoints
- Novel therapeutic mechanisms
- Bespoke workflows or read paths
This balance ensures sponsors can standardize where possible without sacrificing scientific rigor when customization is needed.
From RECIST 1.1 setup to signal, faster
RECIST 1.1 may be standardized, but the way it’s implemented directly impacts trial timelines, data consistency, and operational burden.
By shifting from repeated customization to a pre-validated, standardized framework, Perceptive Imaging enables sponsors to move faster from startup to insight without compromising quality.
In today’s competitive oncology landscape, that speed isn’t just an advantage, it’s essential.
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Chandra Preyl brings over 18 years of experience in life sciences to her role as Vice President of Global Services at Perceptive, where she leads with a deep commitment to customer success. She partners closely with clients to understand their goals, ensuring that every imaging solution is delivered with precision, responsiveness, and measurable value. Known for building strong, collaborative relationships, Chandra focuses on scalable service delivery that adapts to customer needs and drives long-term impact. |
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