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Consulting Service
We provide customized services based on decentralized clinical trials and the expertise and experience necessary for the entire development cycle from the initial development strategy establishment.
DCT Strategic Consulting
1. Feasibility Assessment
Evaluate the feasibility of conducting a decentralized clinical trial by reviewing various factors such as study design, subject population, geographic distribution, available technology solutions, regulatory environment and site features.
It provides insight into whether a decentralized clinical trial approach is suitable and can identify potential roadblocks.
2. Study Design Optimization
Aim at optimizing study design to leverage the benefits of a decentralized approach.
Evaluate endpoints and data collection methods to ensure alignment with remote processes, propose innovative remote monitoring strategies and review opportunities to improve patient engagement and retention through remote channels.
3. Technology Evaluation and Selection
Evaluate and select technology solutions suitable for decentralized clinical trials.
Consider factors such as data security, interoperability between solutions, ease of use, scalability, and regulatory compliance to ensure that the system is available for use with electronic data capture systems, telemedicine platforms, and other remote data collection tools, including in vitro diagnostics and wearable devices.
4. Risk Management
Identify and manage risks associated with decentralized clinical trials.
Develop risk mitigation strategies, establish data integrity and participant safety measures, and ensure appropriate training and oversight of investigators and site staffs involved in remote processes.
5. Site and Investigator Training
Review changes in the organizational system necessary for the implementation of decentralized clinical trials.
It helps support stakeholder engagement, communicate the benefits and challenges of a decentralized approach, address concerns, and ensure approval by key stakeholders such as sponsors, investigators and regulatory authorities.
6. Change Management and Stakeholder Engagement
Help establish robust data management processes for decentralized clinical trials, including data collection, organization, analysis and reporting.
We provide expertise in remote data monitoring, ensuring data integrity, and implementing appropriate statistical analysis methods for decentralized clinical trials.
7. Continuous Improvement
Help sites evaluate the performance and outcomes of decentralized clinical trials and identify opportunities for continuous improvement.
It can evaluate the effectiveness of a decentralized approach, recommend adjustments to optimize future trials, and help develop metrics and key performance indicators (KPIs).
DCT Regulatory Consulting
It provides guidance on regulatory requirements and compliance considerations specific to decentralized clinical trials, and helps sites understand the regulatory environment, navigate differences in regulatory areas, and comply with guidelines and regulations related to remote data collection, informed consent, privacy and data protection.
Process
Statistical Data Review
Data monitoring
Service Scope
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