Services
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Medical Monitoring
Addressing the clinical implications of research
Rho’s Medical Monitors come from life science careers, including experience in medical and academic institutions. Our experts have both clinical and research experience, and some serve as academic investigators. They are able to apply their practical knowledge and experience to present solutions for the issues that occur in clinical trials and research studies. -
Medical Writing
Writers with both industry and therapeutic expertise
Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA. -
Product Safety And Pharmacovigilance
A team of physicians, nurses, and pharmacists
Throughout the life cycle of the program, Product Safety ensures timelines are met in global safety reporting in clinical trials, supports and educates site staff, and provides a safety profile through management and analysis of the safety data as part of their pharmacovigilance services. Our experienced, highly trained safety team is composed of physicians, registered nurses, clinical pharmacists, and medical technologists. These safety and surveillance experts specialize in the collection, evaluation, and submission of safety data in clinical trials. The cornerstone of all of the Product Safety services is the concise and rapid exchange of safety information among all parties. -
Quality Assurance
Promoting excellence in clinical research
At Rho, Quality Assurance (QA) is an independent group that promotes excellence by ensuring adherence to our processes, applicable regulations, and Good Clinical Practices (GCP). Our auditors’ focus on quality has been honed by years of multidisciplinary clinical research training, from extensive education on topics from software validation to GCP to FDA requirements. -
Regulatory Operations
Ensuring confidence in regulatory compliance
As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance. With our experience in drug, biologics, and medical device development, our regulatory professionals offer our clients comprehensive regulatory services to support clinical development, from the preclinical phase to the marketing application phase. Rho’s mission is to deliver quality clinical regulatory services in compliance with good clinical practices (GCPs) and applicable federal regulations. -
Rescue Services
Due to the complexity of clinical trials and the constant struggle to keep trials on schedule, Rho is often called on to resolve issues when processes don't go as planned.
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Risk Based Quality Management
A Robust Risk-Based Quality Management Framework
FDA has placed ICH E6 (R2)—a revision to Good Clinical Practice (GCP)—in the federal registry. ICH E6 (R2) makes explicit the responsibility of the Sponsor to understand and actively manage the risks to quality in clinical trials using a Quality Risk Management (QRM) approach. -
Statistical Programming
Fast, accurate, and informed data analyses
Our statistical programming staff averages over 15 years of experience in the industry and more than 8 years at Rho. Our statistical programmers are engaged throughout the entirety of a clinical development program. We bring this experience and engagement to your product and, as a result, provide fast, accurate, and informed data analyses that you can rely on.