Strong eClinical platforms, sponsor support, and current event demands have made decentralized trial management more accessible to clinical research sites than ever. CRO and site management need to anticipate what practices and technologies will enable decentralized trial management for their work. Here is a checklist of critical considerations as sites seek to begin or enhance decentralized trials.
- Remote monitoring – Is your clinical site able to track research progress both at the central office and remote site(s), including data coming directly from patient wearables, diaries, and telehealth visits?
- Regulatory management – Rethink processes that will need to change with a decentralized trial management system. Document each process and step, determining which tasks will remain, what will no longer be needed, and what will need to be added.
- Compliance – For remote single or multi-site management, consider how you’ll use digital data management to ensure compliance with 21 CFR 11 regulations for electronic records.
- Study selection – Some studies better suited to decentralized clinical trials and certain sponsors that are more comfortable with remote trial design. Think about how enhancing your site’s eClinical capabilities can support both current and future trials and sponsor relationships.
- Patient recruitment & retention – Patients are the backbone of all clinical trial work and their needs, concerns, and constraints should be at the forefront of every decentralized trial management decision. Consider how to establish relationships with patients, even at a distance, and deploy tools to keep patients informed of what to expect and how to get in touch with staff.
- Training – How will training on new remote procedures and software be delivered in a strategic way that meets staff and site needs to ensure the best patient care and sponsor deliverables?
- Technology – How many pieces of software are you using? Do you have one central management system that integrates them all? Consider how the eClinical system you choose will work with current software systems and what you’ll need to know to ensure your technology partner is prepared to integrate as required.
- Evaluation – Determine a set of measurable objectives for your site’s decentralized trial management plans and implement analytic captures within your system to ensure milestones and goals are met.
If you need help selecting the right system to support decentralized management, request a demo of our powerful eClinical solutions. Our team will work with you to ensure that it’s the right system for your site, and we’ll be there every step of the way.