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Post-approval (Phase IV clinical trial) services

Translating science into powerful marketing

Whether you’re working to provide new treatment options through label extensions or trying to demonstrate efficacy over other marketed medications, Rho has the research power that will advance your Phase IV clinical trials. As the balance of your study program shifts from discovery and proof of efficacy to educating doctors and patients, you need to connect with large patient populations quickly and efficiently while upholding clinical integrity. Rho has a broad offering of complementary services to achieve your post-approval goals.

 

Rho provides all of the resources for success in Phase IV clinical trials

Rho enhances the capture and management of all vital post-marketing study data ranging from patient-reported outcomes to critical safety data with advanced technology solutions. Our skilled Medical Writers and Biostatisticians can work with you to prepare robust and influential abstracts, posters, and journal articles. Rho brings the same expertise in Phase IV clinical trials as we do in every other phase of clinical development. Whether you require strategic consultation or core service delivery, Rho uses all of our resources to enhance your post-marketing studies.

 

Our post-approval / Phase IV clinical trial capabilities

Regulatory and Medical Writing
Skilled preparation of abstracts, posters, journal articles, study protocols, study reports, narratives, and submission updates

Product Safety
Rho works closely with clients and site investigators to educate, analyze, and interpret safety data throughout the life of the program

Clinical Operations
Complete operational management services including project management, product safety, and innovative, cost-effective Phase IV monitoring solutions

Biostatistics and Statistical Programming
We can support a variety of studies ranging from targeted, small clinical trials to meet FDA obligations to exploratory analyses of large registry databases to analyze emerging safety issues. Our statisticians excel at collaborating with sponsors to prepare abstracts, posters, and scientific articles

Clinical Data Management
Complete service offering of start-up, processing, validation, and lock of clinical research data

Regulatory Operations
Development and review of documents and dossiers including registries, observational studies, and annual reports/periodic safety update reports

Quality Assurance
Complete service offerings to ensure compliance of all internal and customer standard operating procedures (SOPs), industry guidelines, and regulatory requirements

Project Management
Learn about Rho's project process and how our project management professionals will see to it that your project is completed as efficiently as possible