"Mary Mills & Associates, Llc"

Mary Mills & Associates, LLC, doing business as Mary Mills & Associates, is a woman-owned small business registered to receive awards from the U.S. federal government. The company specializes in providing monitoring services for clinical trials and cooperative studies, primarily for the Department of Veterans Affairs (VA). As a for-profit organization structured as a partnership or limited liability partnership, Mary Mills & Associates has established itself as a key contractor in supporting the VA's research initiatives. The company's expertise lies in ensuring that clinical trials adhere to scientific, ethical, and regulatory standards through comprehensive monitoring and quality control services.

Through its federal contract awards, Mary Mills & Associates has consistently delivered monitoring services to support the VA's Cooperative Studies Program (CSP). These services include on-site and off-site monitoring visits, auditing, and quality control activities across 300-400 VA clinical trial sites. The company's work involves performing Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) monitoring to identify and resolve compliance issues at participating research sites. Notable contract awards include multiple delivery orders from the Veterans Integrated Service Network 22, with values ranging from $54,000 to $585,000. While some contracts have been designated as total small business set-asides, others have been awarded without specific set-aside designations. The primary funding agency for these contracts has been the Department of Veterans Affairs, with a focus on supporting the VA's clinical research initiatives.

Mary Mills & Associates holds a significant Indefinite Delivery Vehicle (IDV) contract with the VA, awarded in April 2021 with a ceiling value of $4,400,000 and an ultimate completion date of April 16, 2024. This multiple-award IDV contract was set aside for small businesses and utilizes a cascading set-aside order of priority beginning with Service-Disabled Veteran Owned Small Businesses. Under this IDV, the company provides GCP CRQA monitoring services to support the VA CSP's Site Monitoring, Auditing and Resource Team. The contract encompasses monitoring services for approximately 25 ongoing clinical trials conducted across 300-400 sites. Task orders issued under this IDV have included various monitoring services, with performance primarily taking place in Albuquerque, New Mexico. This IDV demonstrates Mary Mills & Associates' significant role in supporting the VA's clinical research quality assurance efforts and its capacity to manage large-scale monitoring projects for federal healthcare initiatives.