Quantum Leap Healthcare Collaborative
501(c)(3) non-profit that sponsors and operates adaptive, biomarker-driven oncology platform trials. Provides centralized study sponsorship and operations, integrated clinical data capture with EHR-to-research connectivity, prospective diagnostic and biomarker integration into adaptive decision rules, patient-facing trial-matching and engagement programs, and multi-stakeholder partnerships to run multi-sponsor platform trials (I‑SPY family and related platforms).
Industries
N/A
Nr. of Employees
small (1-50)
Products
Adaptive oncology trial platform
Suite of adaptive, biomarker-informed oncology platform trials that evaluate investigational agents and combinations across molecularly defined patient subgroups, with serial testing and adaptive allocation.
RECAST DCIS Phase 2 platform study
Phase 2 platform study to evaluate alternative, less invasive treatments for ductal carcinoma in situ and to reduce progression to invasive breast cancer.
EDC system with EHR integration for clinical research
Electronic data capture solution designed to integrate clinical care EHRs with research data capture to reduce manual entry and improve data quality for trials; deployed in collaboration with clinical and regulatory partners.
I-SPY trial data and investigator resource collection
Publicly available datasets, publications and investigator resources from the I‑SPY family of trials to support independent analyses and secondary research.
Adaptive oncology trial platform
Suite of adaptive, biomarker-informed oncology platform trials that evaluate investigational agents and combinations across molecularly defined patient subgroups, with serial testing and adaptive allocation.
RECAST DCIS Phase 2 platform study
Phase 2 platform study to evaluate alternative, less invasive treatments for ductal carcinoma in situ and to reduce progression to invasive breast cancer.
EDC system with EHR integration for clinical research
Electronic data capture solution designed to integrate clinical care EHRs with research data capture to reduce manual entry and improve data quality for trials; deployed in collaboration with clinical and regulatory partners.
I-SPY trial data and investigator resource collection
Publicly available datasets, publications and investigator resources from the I‑SPY family of trials to support independent analyses and secondary research.
Services
End-to-end sponsorship and operational oversight for multi-center adaptive trials, including Phase 1 dose-finding arms and Phase 2 platform evaluations.
Mobile-responsive trial-matching and recruitment tools to help patients and advocates find relevant clinical trial opportunities.
Collaborative evaluation, validation and operationalization of biomarker assays (including RNA-based liquid biopsy approaches) and AI-derived classifiers within adaptive trial workflows to support stratification, monitoring and early response assessment.
Deployment and support of electronic data capture systems that integrate with existing EHRs to streamline clinical and research data collection and support regulatory reporting.
Integration of remote patient monitoring devices and symptom-reporting modules into trial workflows to enable decentralized assessments and early toxicity detection.
Recruitment, training and integration of patient advocates into trial governance, communications review, and follow-up data projects.
End-to-end sponsorship and operational oversight for multi-center adaptive trials, including Phase 1 dose-finding arms and Phase 2 platform evaluations.
Mobile-responsive trial-matching and recruitment tools to help patients and advocates find relevant clinical trial opportunities.
Collaborative evaluation, validation and operationalization of biomarker assays (including RNA-based liquid biopsy approaches) and AI-derived classifiers within adaptive trial workflows to support stratification, monitoring and early response assessment.
Deployment and support of electronic data capture systems that integrate with existing EHRs to streamline clinical and research data collection and support regulatory reporting.
Integration of remote patient monitoring devices and symptom-reporting modules into trial workflows to enable decentralized assessments and early toxicity detection.
Recruitment, training and integration of patient advocates into trial governance, communications review, and follow-up data projects.
Expertise Areas
- Adaptive platform clinical trial management
- Adaptive randomization and interim statistical monitoring
- Biomarker-driven trial design and prospective diagnostic integration
- EDC development and EHR-to-research integration
Key Technologies
- Adaptive randomization algorithms
- RNA-based liquid biopsy assays
- AI-driven biomarker analytics
- EDC systems with EHR integration
News & Updates
Announcement that an investigational estrogen receptor degrader will be evaluated in the I‑SPY 2 endocrine optimization program; Quantum Leap is sponsor and will manage study operations across open I‑SPY sites.
First patient dosed in a neoadjuvant combination study within the I‑SPY 2 endocrine optimization protocol; study to enroll participants across multiple I‑SPY sites.
Launch of a mobile-responsive trial-matching platform intended to broaden reach to diverse patient populations and improve access to clinical trials.
Collaboration to expand use of an RNA-based liquid biopsy platform to monitor treatment response and disease burden within the I‑SPY 2 platform trial.
Announcement and award recognizing the integrated EDC solution that links clinical care EHRs to research data capture, cited for efficiency and quality improvements; deployment reported in collaboration with clinical and regulatory partners.
Agreement to incorporate real-time remote patient monitoring modules into the I‑SPY 2.2 trial to support early detection of adverse events and remote symptom monitoring.
Announcement that an investigational estrogen receptor degrader will be evaluated in the I‑SPY 2 endocrine optimization program; Quantum Leap is sponsor and will manage study operations across open I‑SPY sites.
First patient dosed in a neoadjuvant combination study within the I‑SPY 2 endocrine optimization protocol; study to enroll participants across multiple I‑SPY sites.
Launch of a mobile-responsive trial-matching platform intended to broaden reach to diverse patient populations and improve access to clinical trials.
Collaboration to expand use of an RNA-based liquid biopsy platform to monitor treatment response and disease burden within the I‑SPY 2 platform trial.
Announcement and award recognizing the integrated EDC solution that links clinical care EHRs to research data capture, cited for efficiency and quality improvements; deployment reported in collaboration with clinical and regulatory partners.
Agreement to incorporate real-time remote patient monitoring modules into the I‑SPY 2.2 trial to support early detection of adverse events and remote symptom monitoring.