All Cancers – Compassionate Use/Expanded Access
Compassionate Use -Emergency/Compassionate Use (Expanded Access) for Physicians & Providers
Designed for patients for whom standard of therapy is no longer working. These are individual “trials” in which the FDA and pharmaceutical companies work together to provide access to drugs shown effective for specific tumor traits, but not available through other sources. The South Sound CARE team coordinates the process for our patients, facilitating the applications and locating potential Compassionate Use programs within pharma willing to partner to provide drug free of cost to patients.
About
With over 70% of oncology products in development today targeting genetic biomarkers, and often limited access to research studies, the need for a new approach to improve patient access to promising investigational product has never been so urgent.
The South Sound Care Foundation in collaboration with ANOVA’s program OneSource has established a transformative technology-enabled approach to provide seamless support for physicians and providers participating in compassionate use programs, helping to increase access to promising investigational product for oncology patients in need.
Patient Population
Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
Patient enrollment in a clinical trial is not possible or feasible
Potential patient benefit justifies the potential risks of treatment
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication
Program Information
The SSCF program brings participants and providers into the process together and uses workflow automation to enable a more rapid and cost-effective solution.
SSCF has worked with industry to design, develop and deliver a first-of-its-kind solution to help physicians and providers comply with and automate the regulatory and operational requirements for compassionate use – comprising the FDAs Expanded Access program and recently approved Right-to-Try laws.
The SSCF Compassionate Use program provides a comprehensive and transparent approach for all participants, to enable an improvement in patient access to investigational product.
Solutions Available
PRODUCT SEARCH
Matching product that may be available for compassionate use to patients referred
PHYSICIAN QUALIFICATIONS
Document physician qualifications to medically supervise and site capabilities for administration of investigation product under these cases.
PATIENT REFERRAL
Solution for referring eligible patients to open & accruing research studies, and compassionate use pathways.
PROTOCOL & CONSENT
We can prepare a compassionate use protocol and consent form for approval.
REGULATORY APPROVAL
We can help prepare and submit for IRB and FDA approval
CONTRACTING
A solution for documenting contractual relationships & collecting waivers
