Protocol First Selected by the Leukemia & Lymphoma Society (LLS) for Beat AML Master Trial Initiative

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Protocol First (P1), a software-as-a-service (SaaS) EDC data management company, founded April 2015 in Berkeley, California, has been selected by The Leukemia & Lymphoma Society (LLS) for the Beat AML® Master Trial Initiative, a clinical trial in acute myeloid leukemia. The Beat AML Master Trial is among the first cancer clinical trials to be led by a nonprofit health organization and takes personalized medicine to new heights in an effort to bring innovative therapies to one of the deadliest blood cancers. Within seven days of presentation with AML, subjects undergo genetic analysis under a Master Protocol and are assigned to a specific sub-protocol using a novel compound targeting specific gene mutations. Several biopharmaceutical companies are participating in Beat AML along with many prestigious academic cancer centers throughout the United States. Protocol First is providing a novel web-based digital application to help guide the clinicians throughout the trial.

AML is among the most lethal of the blood cancers, which together are the third leading cause of cancer deaths in the U.S.; AML is responsible for more than 10,000 deaths each year. Despite advances in treating other blood cancers, the standard of treatment for AML in the U.S. — a combination of toxic chemotherapies — has remained the same for more than 40 years. Overall prognosis remains poor, with a five-year survival rate below 20 percent for patients over age 60.

"Beat AML is a complex set of oncology and immunotherapy protocols requiring speed of implementation and attention to regulatory detail. Protocol First provides both. Protocol First is purpose-built for oncology and complex trials... eliminating costly unnecessary protocol amendments."

Amy Burd, Ph.D., VP of Research at LLS

Amy Burd, Ph.D., VP of Research at LLS, stated, “Beat AML is a complex set of oncology and immunotherapy protocols requiring speed of implementation and attention to regulatory detail. Protocol First provides both. Protocol First is purpose-built for oncology and complex trials. Before final protocols are launched, P1 technology generates a protocol assessment for internal consistency — eliminating costly unnecessary protocol amendments. In P1, we have centralized electronic source (eSource) data to facilitate remote monitoring and early safety evaluation.”

Brian Chadwick, industry consultant and Beat AML technology advisor said, “There already appears to be a benefit to uploading source data directly into Protocol First. It is facilitating more effective remote monitoring and could support better Risk-Based Monitoring (RBM). The next step is to pilot with Beat AML the P1 Connector to upload data from the patient’s electronic medical records directly into the electronic case report forms, which then get automatically exported to SDTM for faster data review and visualization. This will fulfill a site benefit, it is cost effective, time efficient and provides audit-ready eSource environment.”

Protocol First uses the AWS cloud to achieve scalability and security required for a next-gen EDC system that contains eSource. Protocol First is built to be compliant with all relevant regulatory requirements, including the new ICH E6 (R2) guidelines for Good Clinical Practice. Hugh Levaux, Ph.D., Protocol First’s Founder and CEO said, “Given that these protocols are most complex, we are pleased to have been able to support the timelines, scale, and security requirements of Beat AML in our Cloud environment.”

About Protocol First
Protocol First aims is a Software-as-a-Service company offering next-generation clinical trial software. Protocol First aims to bring massive productivity improvements to the entire clinical development process with better technology solutions. 

Founded in 2015 and headquartered in Berkeley, California, Protocol First software is used by leading biopharma, CROs and non-profit organizations to power complex clinical trials in oncology, immune-oncology and other difficult therapeutic areas.

Media Contact:  
Joseph Collins

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in Rye Brook, NY, LLS has chapters throughout the United States and Canada. To learn more, visit Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.

Source: Protocol First, The Leukemia & Lymphoma Society

About Protocol First

Protocol First is the Next-Gen EDC platform, offering the world's first fully integrated solution from EHR-EDC-SDTM, yielding 100% clean data reducing Site Burden and need for SDV. The entire platform yields improved data quality, faster.

Protocol First

Berkeley , California

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