Resource Profile

MICHMER is a research organization that provides a wide range of services to sponsors and institutions in the healthcare and biomedical research fields. Its services include biostatistics, regulatory services, data management, site management, and lab services. MICHMER has a team of biostatisticians and consultants who provide expertise in study design and analysis. They also collaborate with biostatisticians from other national and global research institutions. MICHMER’s regulatory services include regulatory consultation on FDA, GCP, and HIPPA compliance, informed consent design, protocol writing, preparation and filing of investigators initiated IND/IDEs, safety reporting to regulatory bodies, and clinical study reports. MICHMER also provides data management services such as database design, forms management, web interface and GUI development, database programming, medical coding, case report form design, data entry, and status reporting. MICHMER’s site management services include site feasibility and qualification, on-site training for the investigational team and study staff, patient recruitment services, archiving trial documentation and quality control, and centralized management and monitoring of sites. MICHMER’s lab services include a full range of clinical laboratory services supported by hospital-based and outpatient service centers. The laboratory staff is comprised of highly experienced scientists committed to quality, accessibility and cost effectiveness. The laboratory network supports all types of needed lab work and could transport samples from remote sites to main hospitals. MICHMER’s services are designed to meet the needs of sponsors and institutions of all levels of sophistication. They encourage their clients to consult with them as early on as possible.