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Clinical Services
BioFicher exists to provide its clients with the skill sets, technologies, and dedicated services required to manage clinical research studies. As a CRO we embrace your goals and manage your clinical research as if it were our own. To help you conduct research that meets the highest standards of quality, we apply a unique toolkit of clinical research professionals, advanced technologies, and decades of global clinical research experience.
Whether you require a full-service CRO or a functional outsourcing relationship, BioFicher welcomes the opportunity to collaborate with you.
Clinical Research Services
Our mission involves searching for truth in human health issues through the design of high quality research studies. The integrity of research remains our highest priority, and we bring a solid statistical approach to every phase of your clinical study, including protocol development, study design, site/investigator recruitment and management, data collection/management, statistical analysis, regulatory filing, and publications.
Biostatistics
BioFicher biostatisticians partner with you to improve your study’s performance from initial planning through data analysis and reporting. Our shared goal is to optimize your trial, data quality and study results.
Advantage eClinical
Advantage eClinical is BioFicher’s clinical trials electronic data capture platform. Co-developed by IT and data management professionals, biostatisticians, clinicians, medical officers, programmers and analysts at BioFicher, Advantage eClinical provides users a full suite of eclinical technologies to manage studies from early trial planning through close of study.
Biomedical Data Science & Bioinformatics
Our Biomedical Data Science and bioinformatics solutions combine state-of-the-art statistical methodology with information technologies to process, analyze and integrate large-scale clinical research data.
Clinical Safety and Pharmacovigilance
At BioFicher, we understand the importance of patient safety to our clients and the assurance of managing enrolled patients safely through the duration of your study. We aim to provide you with a forward-thinking approach and a coherent safety data plan. Then in collaboration with you and clinical trial sites, we ensure that you effectively capture and analyze safety data, identify data interrelationships, and proactively uncover adverse event trends.
Real-World Data and Real World Evidence
Clinical research that effectively combines clinical trial data with real world evidence (RWE) of drug effectiveness, safety, or variability across subpopulations has become essential in supporting drug development and regulatory submissions.
Regulatory Affairs
Effectively navigating the investigational and new drug, device and biologics regulatory pathways is a critical element in the successful development of your product. During each stage of development, you face regulatory issues that can potentially impact your product timelines and chance of gaining regulatory approval. At BioFicher, we understand your challenges in clinical product development and provide proactive guidance to mitigate development and regulatory risk.
Medical Devices
By applying significant experience managing medical device studies across therapeutic areas, BioFicher can help you successfully develop and market your products by applying thoughtful regulatory, economic, and development strategies, as well as meticulous clinical trial execution.
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