In order to facilitate multi-site studies for sponsors that require large patient population coverage, MICHMER provides a centralized process of managing and monitoring sites with a robust IT infrastructure and a staff of highly qualified individuals. This enables sponsors to handle several sites at the same time with no incremental resource costs.
Our biostatistics group was formed as a research team dedicated to biostatistics and clinical research. MICHMER has an important role in developing and applying biostatistics methods to the clinical study and health outcomes.
MICHMER can handle submissions and follow up on IRB applications and approval. The IRB pre-submission process requires three committees to submit initial reports.
MICHMER provides a full range of clinical laboratory services. With highly qualified lab technicians and specialty MD’s, our labs are operated in strict compliance with regulatory standards with a focus on quality assurance and quality control.
At MICHMER, we realize the importance of data management in the success, accuracy and safety of data. Therefore, we utilize advanced tools led by staff with extensive experience in data management.
At MICHMER, we manage and compile the documents required for pharmaceutical regulatory affairs, IND and NDA submission. The submission involves all the documents containing the details of the new drug and clinical trial.Our staff offers the best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO industries.
With vast experience in hundreds of clinical studies, MICHMER’s multi-disciplinary staff will bring excellent insight to our sponsors’ studies. Our staff identifies qualified principal investigators from a large list of potential investigators, considering experience and patient population. We do an in depth analysis of the feasibility of conducting clinical trials at the proposed sites.