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Clinical Development
Study Start-Up
Study Start-Up is an important step in clinical trial management that includes a series of activities and processes that must be completed before enrolling subjects into a clinical trial.
An effective Study Start-Up service ensures that your study is conducted efficiently, safely and with high-quality results.
As a dynamic step that manages cost and quality while keeping the time to site activation as short as possible, Spero manages various elements of activation in parallel and enables early start of research.
DCT SSU
The SSU in decentralized clinical trials is designed to reduce the need for face-to-face visits and increase participant convenience by utilizing digital technologies and remote data collection methods.
Regulatory and ethical approval :
In order to proceed decentralized clinical trials, approval from regulatory authorities and ethics committees (EC) or institutional review boards (IRB) is required, and preparation of a protocol, an informed consent form and other additional reference that meet the new criteria is necessary.
Data management and monitoring plan :
Develop a robust data management and monitoring plan to ensure data integrity and subject safety throughout the clinical trial.
It defines procedures for collecting, storing and analyzing data and mechanisms for remote monitoring and safety reporting.
Communication and support channels :
Establish clear communication channels with subjects and site personnel to ensure ongoing support, resolve queries, and resolve any issues that may arise during the trial. This may include regular virtual meetings, a dedicated help desk, or an online support portal.
Process
Overall IRB Affairs
IRB (Institutional Review Board)
Inital Submission
Service Scope
(Remote)
Feasibility
Site contract
Site contract
Overall IRB Affairs
IRB (Institutional Review Board)
Inital Submission
(Remote)
Feasibility
Service Scope
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