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Phase I clinical trial services

Comprehensive early-phase CRO services

For all of our Phase I trials, we provide robust research capabilities, including regulatory and medical writingclinical data management, statistical expertise in pharmacokinetic and pharmacodynamic analyses, and experimental design, including adaptive design options. For early developmental studies, Rho maintains relationships with established, quality-driven Phase I centers. This rapport promotes greater collaboration, reduces costs, and speeds the delivery of trial results.

Rho delivers cost-saving answers to Phase I development

For the early stages of drug development, Rho provides packages for Phase I clinical trials that have predictable cost structures. Our approach delivers data integrity in a model that provides cost and time controls and reliable results. We employ data standards (like clinical data acquisition standards harmonization [CDASH] and Study Data Tabulation Model [SDTM]) that provide substantial cost savings later in the drug development process.

Standardized electronic case report forms (eCRFs) or case report forms (CRFs) reduce time required for database development, edit-check programming, data processing, CRF annotation, and data transfer. Standardized data displays with pre-validated code reduce development time of statistical analysis plans while enhancing uniformity and providing efficiencies across your clinical trials in any study program. The Rho Regulatory and Medical Writing team, in collaboration with Biostatistics and Statistical Programming, has created an integrated and automated standardized process for the production of a Phase I clinical study report (CSR) including appendices and narratives. For example, Rho auto-generates in-text panels directly from the corresponding standard summary tables for inclusion into the CSR to increase efficiency and reduce cost.

Rho encourages the establishment of strong bonds during early-phase research

We value developing long-lasting relationships with our clients and investigators. That's why we cultivate collaborative relationships with our sponsors during
Phase I—relationships that can last the duration of the development process.

Rho’s phase I services include: