The Top Ways Pharmaceutical Companies Increase Efficiency and Overcome Common Issues for SIVs (Site Initiation Visits)
When we started the process of site selection for an upcoming clinical trial, there are many things to be considered and planned for before the Site Initiation Visits (SIV). Believe it or not, there are ways to make some of these preparations more efficient. One of the more time-consuming activities that needs to be completed before your sites can start seeing patients is ensuring site staff completes all required training. It seems like a daunting task, especially if the options are limited. As a CRO or sponsor, what are some of the things you can do to make the process more efficient?
Common Issue:Your site either missed or was unable to attend the live Investigator Meeting.
Perhaps your site on-boarded to the study later in the study and the live Investigator Meeting has already occurred. How can your site access the sessions from the Investigator Meeting to ensure the staff is fully trained on the study?
Solution: Consider a hybrid approach to training.
Investigators meetings are important for many reasons, including providing the ability to collaborate with colleagues and peer groups for new ideas and tips. Your sites are on-boarded and your investigator meeting is scheduled. Unfortunately, some of your sites are unable to attend due to scheduling conflicts. A live broadcast of your Investigator Meeting with interactive Q&A would solve that problem. Sites who are unable to attend can still actively participate, and receive instant feedback, and provide a forum to consider questions that you may not have thought about.
Also, you can record your investigator meeting, as it happens, and edit it into different modules to upload onto a web-based platform that sites can access. There are several methods available to ensure the sites have viewed the session including incorporating watch codes and end of module quizzes.
Increase Efficiency:Training assignments are not based on role.
The list of training assignments is long, and your site is fully staffed with people who have different roles and responsibilities for the study. Some will need to take more training than others. Is there a way to configure training assignments, easily, by role?
Solution: Training assignments are configured based on roles and responsibilities.
Consider a training platform that is configurable based on the roles and responsibilities of the individual who is training. This will save time and enable site staff to concentrate on core tasks and spend more time with patients.
Common Issue:Redundant training.
Many top tier sites support more than one clinical trial. They may even be supporting more than one clinical trial for your company. Is it possible to have certain training, once complete, carry through to the other studies, saving your site staff time which can be spent on core study activities and seeing patients?
Solution: Capturing training that has already occurred eliminating the need to recertify.
Every sponsor sends out the complete list of topics, regardless of how many studies I’ve supported for them. Try implementing a training platform that will track non-protocol specific, standardized training that has already occurred, even if it was for another study. Cross sponsor mutual recognition of training requirements can save hundreds of training hours.
Increase Efficiency:Safety Event Acknowledgements
Often an SAE or SUSAR could have already occured before your new site has launched. How do you ensure your sites process these notifications quickly and in compliance with regulations?
Solution: Consider implementation of an automated safety notification solution
Implementation of a solution that can be configured based on specific country rules, and grouped by study, compound or therapeutic area. All of your sites can browse, acknowledge and retain SAEs and SUSAR’s easily and submit to IRBs and ethics committees as needed. This automation ensures all safety notifications are delivered simultaneously and accessed at any time. Metrics are easily tracked and reportable. With this solution, your sites remain compliant with FDA and ICH regulations and are inspection ready. It also saves site staff time associated with tracking and following up on events and saves the sponsor time in preparation and manual delivery of notifications.
Ensuring documentation is available to sites.
Once a study completes their training, do you as the sponsor have the ability to view all the certifications and track each site’s progress as training is completed? Are certifications kept in a single location that can be easily accessed by your company and the site, so you are always inspection ready? Are safety notifications easily tracked and reported? What about your other regulatory documentation – protocol amendments, startup documents, etc.
Solution: Keep important documentation at your fingertips and always inspection ready.
Consider a solution that ensures your safety notifications, training certifications and other study documentations is appropriately acknowledged, tracked, reported and available in a user friendly platform that keeps your sites in a perpetual state of inspection readiness.
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