Clinical Development

The goal of the clinical development phases of a trial—Phase I through Phase IIIa—is to submit a request for approval for a treatment to a regulatory agency. The goal of technology during this process is to provide tools to the researchers that make the process more efficient, less manual, less time-consuming and more insightful.

The initial steps of planning and setting up the clinical study are critical to its commercial success, as are the relationships the research team has with its investigative sites and, where relevant, the contract research organization to which it outsources research functions. Medidata Grants Manager® and Medidata CRO Contractor® utilize constantly updated data from negotiated contracts to provide researchers the benchmarking data they need to optimize their relationships with key third parties.

Medidata Designer® brings the significant benefits of electronic management to the protocol authoring stage, and its benefits can help throughout the other downstream processes of an eClinical trial, such as the EDC and analysis systems.

Automating clinical trial data collection through an EDC system has now become standard practice with most large pharmaceutical companies, having proven its worth in time and cost savings, and is increasingly being evaluated in small and mid size companies. Industry-leading Medidata Rave® provides a platform of robust functionality for these processes, as well as data management that produces significant efficiencies throughout the process, speeding access to clean, reliable clinical data through facilitating the preparation of documents for the regulatory submission. With all studies in a single database, Rave requires less set-up and configuration time for multiple studies and studies in subsequent phases, reducing start-up and study build time.