We administer and support clinical trials with a full slate of clinical trial operations capabilities. 

STUDY PLANNING AND SETUP

• Investigator-Initiated Trial (IIT) protocol design and development
• De novo epidemiological survey development and pilot testing
• Study budgeting, contracting, and payment administration
• IRB package creation and management
• ClinicalTrials.gov registration and updates

SITE AND PARTICIPANT COORDINATION

• Site recruitment and study startup
• Subject qualification, consent, and enrollment

TRIAL EXECUTION

• Remote decentralized clinical trial (DCT) coordination and monitoring
• Blood sample kitting and remote phlebotomy logistics
• Collection and maintenance of a 3,000+ specimen biobank

OVERSIGHT, DATA, AND COMPLIANCE MANAGEMENT

• Trial timeline oversight and reporting responsibilities
• Centralized data management and cleaning
• Trial master file (TMF) management and maintenance
• Quality assurance and regulatory compliance

RESULTS COMMUNICATION AND COMMUNITY ENGAGEMENT

• Medical writing and conference presentation development
• Strategic social media and awareness communications
• Direct engagement with patient communities and advocacy networks

All ALCMI trials adhere to the International Conference of Harmonization (ICH) standards, Good Clinical Practice (GCP) best practices, and U.S. Food and Drug Administration (FDA) regulations.