PHASE I CLINICAL TRAIL SERVICES
Phase I clinical trial services
EDATAKA delivers cost-saving answers to Phase I development
For the early stages of drug development, Edataka 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 Edataka 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, Edataka auto-generates in-text panels directly from the corresponding standard summary tables for inclusion into the CSR to increase efficiency and reduce cost.
Comprehensive early-phase CRO services
For all of our Phase I trials, we provide robust research capabilities, includingregulatory and medical writing, clinical 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.
Phase II and Phase III clinical trial management services
Edataka's experience advances Phase II and Phase III trial management
Edataka is adept at managing every aspect of Phase II and Phase III trials. We offer a broad range of services that allows us to provide capacity and experience in clinical trial management.
Clinical operations provides experience and leadership at each site
The value of Rho's Clinical Operations lies in the experience we bring to the client. As a result, we can provide strong site management and enrollment strategies. We consider the Lead Clinical Research Associate (LCRA) to be an integral part of the study—that’s why ours have an average of 5 to 10 years of clinical operations leadership experience. Our non-regional CRA model allows our CRAs to develop expertise within therapeutic areas, become more closely integrated with the rest of the project team, and focus on a smaller number of protocols.
Medical monitoring services with a focus on safety
Edataka's Medical Monitors are a vital component to Phase II and Phase III clinical trial success. Medical monitoring plays an important role in providing protection to research subjects, integrity of results, and consistency of protocol. Our team of Medical Monitors is composed of an on-board staff and worldwide network of specialist physicians that guide study teams through the issues faced in clinical research studies.
Robust statistical services and advice
Our creative statisticians design small yet flexible Phase II studies. We critically review Phase II results, investigate data accuracy, and conduct power analyses when designing larger Phase III studies. Our statisticians support data and safety monitoring boards (DSMBs) and conduct interim analyses. Because timing is so critical in these phases of development, our counsel can help you make timely and informed decisions about sample sizes and doses, which will guide your program development.
Clinical data management capacity
Phase II and Phase III studies require strong capabilities to handle a large volume of sites, subjects, and case report forms (eCRFs or CRFs). Edataka delivers the clinical data management capacity necessary for these vital phases of development. We've demonstrated this strength in successfully completed projects with hundreds of sites and thousands of subjects.