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Indisputably, with its numerous benefits, decentralized trials are a promising alternative in respect to the future of clinical trials and subsequent trial design.
Decentralized clinical trials have the ability to exploit technological developments to improve the patient experience and increase performance efficiency of clinical research. Whilst DCT's are fast becoming a real alternative to standard centralized trials, there still remains a lot of uncertainty and potential obstacles that can lead to failure. Surprisingly, there is no regulatory framework or guidance to support DCT's, which is why country specific intelligence is paramount. In addition, a decentralized trial must be sufficiently prepared and all additional considerations such as Direct to Patient delivery, technology etc but be submitted with the Investigational Medicinal Product Dossier (IMPD).
At SanaClis, we provided expert support throughout the entire DCT process, from early onset planning such as protocol development, IMPD submission, technology, Supply Chain, through to Direct to Patient and Global Home Nursing network.