mIRT to support Direct-to-Patient (DtP) Clinical Trial

mIRT’s Clinical Trial Supplies Management Technology Allows Pharmaceutical Companies to Continue Clinical Research Efforts Amidst the COVID-19 Pandemic in Accordance with FDA Guidelines

DDi’s mIRT offering sponsors the flexibility to ship drug directly from the site, depot and/or central pharmacy to the patient's home with its Direct to Subject module.

Direct-to-Patient clinical trials are absolutely contactless and they are carried out within the patient’s house preventing them from traveling to the investigator site. Amidst the COVID-19 pandemic, the importance of DtP clinical trial models are doubled to ensure patient safety and make accession of trial kits easier. In turn, it curbs the challenges of site capacity and disruption in the supply chain.

mIRT’s Direct to subject module supports all main models of Direct-to-Patient models that include Depot-to-Patient, Central-Pharmacy-to-Patient, Site-to-Patient and Hybrid. Customization can be done to this based on patient, study, site and country to implement various DtP models in one study. This helps in coping with the various rules and regulations worldwide. Given the situation we are in today, sponsors need the scope to adapt as we further enter into this crisis situation. Our Direct to Subject Module can be utilized for a certain period, for all or selected visits, with the ability to turn it off while the study is running. This would offer the sponsors the flexibility to continue their research through the COVID-19 pandemic and to return to normal once it has passed.

Direct-to-Patient clinical trials aim at improving enrollment and make accession of trial sites easier for patients. COVID-19 might be the catalyst that moves the industry towards a DtP approach but its advantages stand clear.

About DDi:

DDi (Drug Development informatics) specializes in providing AI & Automation to Life Sciences industry. As a global technology partner serving Life Science organizations since more than a decade, DDi leverages its rich functional domain expertise and technical competency to design and build innovative SAAS solutions for Pharmaceutical, Biotech, and Medical Device manufacturers. We provide smarter solutions with best ROI, deep Regulatory & Quality knowledge, strong interpretation team to link systems & data, agile team with global implementation experience and secured data hosting in multiple Countries. Our customer base includes organizations from Top 100 global pharma companies to small & mid-size biotechnology, medical device companies as well as academic/ research institutes.