Clinical Trials
Your Trusted Clinical Trials And Compliance Partner.
Trial Set-up & Strategic Advice
ADMFES facilitates the clinical trial startup process and offers additional flexibility in response to clients’ outsourcing demands. Our highly experienced staff initiate clinical trials by providing Optimization/strategic feasibility, Country/site selection, Strategic site partnerships, Investigator qualification, Site activation (local regulatory submissions, site contracting, and clinical startup), and Patient recruitment.
Clinical Project Management
ADMFES designates a Project Manager (PM) selected based on their background and skills aligning with the project needs. Collaborating with our PMs, we redefine the meaning of "partnership" by ensuring clear communication of your expectations from study start-up to closeout.
Clinical Trial Monitoring
Our Clinical Research Associates (CRAs) play a pivotal role in overseeing trial activities, coordinating study meetings, and managing sites. They monitor visit objectives including site startup activities, IRB/EC meetings, compliance to protocols, patient screening/enrollment, source data verification (SDV), and drug accountability.
Clinical Data Management
ADMFES maintains data integrity through strict adherence to Good Clinical Data Management Practices (GCDMP). We provide Electronic Data Capture (EDC) system training, eCRF design, data management documentation (DMP/DVP), database coding, safety/lab reconciliations, and 24/7 EDC helpdesk support.
Clinical Biostatistics Services
Our biostatistics team delivers comprehensive statistical support for protocol development, study design & endpoints, sample size calculations, randomization schedules, interim analyses, and integrated summaries of efficacy/safety for regulatory filings.
Quality Assurance & Compliance
Our Quality Assurance (QA) team conducts periodic audits of clinical processes to maintain a robust Quality Management System (QMS). We offer vendor/investigator audits, system/study audits, Clinical Study Report (CSR) audits, pre-inspection reviews, and SOP writing.
Clinical Consultation
Speak with our Clinical Trial managers for project feasibility analysis.