0. Intro to Guidebooks

RegAsk has designed DCT Guidebooks for 27 territories; which provide vital and validated current information on the regulatory framework around the Clinical Trial applications with a deep dive into DCT elements and their nuances. The information in the guidebooks is presented in an easy-to-comprehend format that could facilitate the applicant and their stakeholders to understand the general Clinical Trial regulatory framework and DCT component in a manner so they can adjust and virtualize as much or as little of your trial as they need.

The guidebook covers a range of information in significant detail. End-to-end information needed to form DCT strategy from importing the investigational samples, location and qualification requirements of investigators, eConsent, eSingature, ePRO, HHCP visits to verification and validation of data storage protocols and data transfer regulations is captured in detail in each guidebook.

Our subject matter experts have presented information and their interpretation of the published information. Additionally, each piece of information is well backed up through valid references so the reader can form their own interpretation and answers should they have different questions. Applicants can use the presented information to form their clinical trial application strategy with the combination of information in one guidebook for a successful trial.