We have previously discussed in our Earlier Blog, “Top 3 Challenges of implementing mobile specimen collection in decentralized trials (DCT)”, the critical challenges to be aware of in implementing mobile specimen collection in the DCT settings. We have explained the same challenges in this blog for reference and solutions to overcome them. To help clinical trial teams prepare for a decentralized world, we’ve put together a guide to overcoming the challenges of implementing mobile specimen collection in decentralized trials.
Challenge 1: Regulatory Considerations
There are often regulatory restraints to be faced especially while facing complex PK/PD Biomarker studies. Demonstration of reliability and sterility of samples and processing in frozen conditions in DCT settings can often be tedious.
myOnsite has developed specific standardized protocols to deal with complex research studies. For Instance, in Pharmacokinetic / Pharmacodynamic studies, alternatives to refrigerated centrifuges can be implemented. Specific protocols can be used to use mobile centrifuges at room temperature, and dry ice used for storing the spun samples in frozen conditions.
Challenge 2: Security and Reliability of Data and Storage
There are various stakeholders regarding clinical trial data, such as the Lab, CRO/Sponsors / Sites, and remote patient homes. Questions often arise on how the data is shared and, most importantly, security to connect all the components.
The answer lies in one standard solution – Implementing Cloud-based platforms with HIPAA regulations and 21 CFR Compliance. At myOnsite, we have proprietary Cloud-based solutions which can be used with secure and reliable data storage. We provide mobile specimen collection paperless with fully automated processes from Orders, Scheduling to Results.
Challenge 3: Training Phlebotomists and Nurses on Complex Procedures
There are various phlebotomists / Nurses in different locations, and hence, some of the studies require protocol-specific training as well as equipment handling. Bringing all the phlebotomists and Nurses together and training them is challenging.
Phlebotomists are directly recruited under myOnsite with proper background verification checks. All healthcare professionals are under the Learning and development system. Clients can provide study-specific training remotely with a live web meeting or in-person for specific studies if required. Specimen handling instructions that are precise and crisp can also be set up in the cloud-based phlebotomist app, which can be set for specific studies.
By following these guidelines, clinical trial teams can address the challenges of implementing mobile specimen collection in decentralized trials and ensure that the data is accurate, secure, and collected on time. Mobile specimen collection can effectively increase clinical trial access and provide greater patient convenience.