This is the fourth post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background on TransCelerate and the SIP, see the previous three posts. In today’s post, we’ll be looking at the common challenges pharma companies face as they work to adopt the SIP.
If you happen to be a pharmaceutical start-up that is preparing to conduct your very first trial, using the SIP for that trial would be fairly straightforward. With no legacy studies in flight, no clinical IT systems in use, and no business processes in place, all you might need is a standard operating procedure (SOP) that says you use the functionality available in the SIP to conduct your trials, albeit after some user acceptance testing (UAT).
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But that does not describe the vast majority of sponsor organizations. Most of you reading this – including CROs – already have processes and systems in place, with multiple studies in progress. And, most likely, some of your IT systems overlap with standard SIP functionality (e.g., training, document management) and some of your processes differ.
Consider a few common challenges that are faced by SIP adopters:
- When the SIP offers functionality and/or processes that overlap with your IT systems and processes, how do you decide with which to proceed? What if your existing systems are robust and are working well for you?
- When you decide to keep using an existing system, how do you get it to work seamlessly with the SIP? Is your existing system even capable of integrating with the SIP’s single sign-on platform?
- Once you have your systems working seamlessly with the SIP, how do you handle technical support tickets from sites? How will you figure out which system they are struggling with when it appears to them as a single system?
- In any and all scenarios, how will you effectively and efficiently roll out changes to site users without overburdening them and without disrupting study operations?
- Where and how do your CRO partners fit in?
Given all of that, how do you decide whether joining TransCelerate and adopting the SIP is right for your organization? If you make the choice to adopt the SIP, how do you ensure a smooth transition with minimal disruption to your business operations and site users?
The next couple of posts in this series will provide guidance on both of these questions. Check back soon! In the meantime, check out this brief video that describes a project we completed for one of the TransCelerate member companies, and fill out the form below to download our related guide, Perspectives on the TransCelerate Shared Investigator Platform.