Blog

On October 27th, Exostar hosted the second in their “Partners Webinar Series” with Cognizant SIP. Exostar’s Kenny Kong and Cognizant SIP’s Dr. Lestter Cruz Serrano acknowledged that clinical trial site users need help. Too many credentials and too much redundant information to maintain adds another layer of complexity to their jobs. It doesn’t have to be that way. Details were shared how many clinical sites are able to accelerate clinical trials and improve the site user’s experience with eISF and SSO. Some great questions came from the session we’re happy to share in case you were wondering the same.

The Exostar’s Partner Webinar Series is available for On-Demand viewing:
October 27 – On-Demand “Increase efficiency and accelerate trial timelines with eISF and SSO,” presented by Exostar & Cognizant SIP  (Note: On-Demand viewing is available via ACRP’s website. Registration is required, but the event is free of cost.)

August 27 – On-Demand “Winning the Competition for Clinical Sites by Reducing Site User Burden” presented by Exostar and Almac Clinical Trials

Answers to the questions from the webinar:
Q: I already have Single Sign-On. What’s the difference with yours?
Many Sponsors have enabled Single Sign-On but only in the context of their studies. For these Site User who work with multiple sponsors, they unfortunately are still saddled with multiple logins. Exostar is the only identity that consolidates all of those logins into one across ALL sponsors for a true SINGLE Sign-On experience.

Q: How can I get an Exostar Account?
The Exostar identity is an invitation-only service so speak with your Sponsor and they’ll be able to set you up with one.

Q: What are some of the benefits at the site level with engaging with Cognizant SIP SSO?
Ability to seamlessly access multiple different applications across various sponsors using a single credential. This may eliminate the need to create accounts across all the applications and may remove redundancy of providing the same information for each application. You provide basic information to Exostar and it can be leveraged across all applications
SSO allows sites to consolidate and streamline their access to each clinical system through SIP thereby improving user experience.

Q: How can I join the Shared Investigator Platform (SIP)?
The SIP is an invitation-only service so speak with any of our 7 Sponsors or email us at SIPOnboarding@cognizant.com to request an invitation.

Q: What are the specifics involved in “maintaining SIP” from a site perspective? Can the site assign that responsibility to 1 or 2 Facility Profile Managers?
Yes, sites can assign multiple Facility Profile Managers. There is no limit on the number of FPMs who can be assigned at any one site.

Q: How about these facility profile managers being copied on communications sent to site staff (as initiated by each sponsor per protocol)?
Sites also have the ability to assign “Facility Clinical Trial Contact” who can be copied on all surveys and study invitations sent to investigators at their locations. Both the FPM and the FCTC roles can be assigned to the same user(s).

Q: Can smaller sponsors implement Cognizant SIP?
Yes. SIP caters to all Sponsors. It is a collaborative platform for sponsors and sites to interact on trials. Seven sponsors have signed onto SIP. These include Merck, BMS, Pfizer, Eli Lilly, Roche/Genentech, Amgen, and most recently Bayer. We are currently in discussion with other sponsors.

Q: Can you please share the financial benefit of SIP compared with the traditional platform?
The ability to have more PIs doing studies and continually reuse their information for other studies with sponsors has not only saved time but the overall efforts that are required during the clinical trial process.
With the percentage of “one-and done” PIs in clinical trials at 50%, (NIH, 2019), losing PIs is a major concern for Sponsors. With SIP’s ability to easily onboard PIs for additional studies, SIP mitigates that challenge.

“As a testimony to the increase in SIP’s ability to handle remote studies through COVID, in just 4 months, SIP has had an increase of 128% in the number of active studies from 517 to 1178 from April 2020 through Aug 2020.”

Q: From the perspective of cybersecurity, have you experienced any data security issues between trials and how did you manage those issues?
No we haven’t had any data security issue between trials reported in SIP platform till date. We have a well-defined Major incident management process through which any data security, privacy, and security issues will be managed.

Q: Is there a way for assigned “Faculty Profile Managers” to be copied on initial invites to investigator’s and other staff that are sent from SIP?
Yes. As a Facility Profile Manager you can add any user to be a Facility Clinical Trial Contact. The FCTC is copied on all Survey and Study Invitation notifications sent to Investigators associated to Facility. Registration invitations sent from the system are only sent to individuals (PIs) and hence other staff are not copied on them.

Q: I understand the sites can have a Faculty Clinical Trial Contact – with primary use is for surveys/site, invites/site selections – what about a site delegation to be continuously in the know via copied on site communications beyond the point of site selection or as part of the registration of new staff in SIP? We have a large site that looks towards a central office within the site project, advise and facilitate the successful use of SIP?

Within SIP we have the ability to set up central teams for investigators with all of these activities. In SIP, we refer to this as the Organization Profile. Facilities may indicate their participation and affiliate themselves to the Organization in the platform. In the Organization profile, you will be able to provide central teams to provide assistance for User Profile completion, Feasibility Survey’s and SIP Study Site Maintenance for all the affiliated facilities and its staff.
If you set up an Organization Profile than you can have specific users be identified as a User profile contact, Feasibility contact and delegate for SIP Study Site Maintenance in order to complete these activities.

Q: Investigator physicians receive 100’s of emails a day. Is there a way that when SIP generates a notice to investigators/other site staff that the subject line, introductory statement can fully identify the sponsor, protocol number & abbreviated name, along with the reason for the message? Current messages generated from SIP are received from 1 of 3 different senders but the message is not easy to decipher nor easy to relate to at a site level?
These emails sent from SIP include the sponsor, study ID, and the abbreviated name. Investigators have the ability to digest their emails to ensure they are not overwhelmed by multiple emails. They may choose to digest emails for certain functions while ensuring they are alerted immediately for functions such as a new safety document.

Q: How are CRO’s using SIP? Is that sponsor dependent?
SIP has a provision for CROs to be on-boarded as a user group to manage their studies across multiple sponsors. Alternatively, CRO users may also be on-boarded through the respective sponsor for specific studies.

If you have additional questions or would like to speak further about SSO or eISF, please reach out to us at lifesciences@exostar.com.