By Penelope Manasco, MD, CEO, MANA RBM and Michael Smyth, Division President, TransPerfect, Trial Interactive
It has never been more critical to ensure flexibility in your clinical operations. Industry experts Penny Manasco and Michael Smyth discuss key considerations for effectively launching remote trial management for current or upcoming studies.
In response to COVID-19, the clinical trials industry has had to shift many on-site activities and procedures to a virtual environment. While managing clinical trials without direct access to sites has presented unique challenges, this shift also presents opportunities to enhance the accuracy and efficiency of clinical trials with new technology and processes.
If you’re in the midst of looking at remote trial management solutions, it’s important to look for technology that is easily accessible, scales with your organization’s needs, and will be ready to launch quickly. Implementing a new remote trial management solution requires a combination of the right technology and processes to help you facilitate a successful clinical trial without the ability to physically go to your sites. Every process and piece of data associated with an on-site visit must have a corresponding remote process and documented data source. Before beginning your search for the perfect remote trial management solution, answer these questions:
- How would you monitor a trial if you did everything remotely?
- How would you access your data?
- How would you access your essential documents?
Don’t forget to consider how you’ll avoid some of the most common clinical trial site failures as you shift to a remote trial management approach. According to the FDA, these are the top five clinical trial site failures found during audits:
- Failure to follow the investigational plan
- Inadequate records (including source records)
- Inadequate IP oversight
- Inadequate Informed Consent
- Inadequate safety reporting
In this whitepaper, we’ll show you how to choose a vendor that can provide you with the right solution to not only ensure your clinical trials maintain accuracy and compliance as they go virtual, but also help you innovate your approach to clinical trial management.