We Hear You
We have consulted with lots of sponsors in the past 3 months about Risk Based Monitoring. We were amazed by the similarities and degree of the pain points we all face in clinical research. Unfortunately, we have been talking about these issues for the past decade. It is time to make a difference TOGETHER!
WHAT WE HEARD…
Sponsors want more transparency, less noise and the TRUTH.
How can we get a clear picture of what is really going on with our studies when we use multiple vendors and different systems? How confident are we that every study is ICH GCP R2 compliant? How can we be more proactive and less reactive? How do we know that the study team is focused on the most important issues and that everyone knows when these issues are handled and documented? We heard a story where a project manager is rewriting status reports from their vendors so they could present a complete picture to their manager. We heard from study managers that have no visibility as to when monitoring visits took place.
Sponsors need knowledge to transfer from study to study to eliminate mistakes.
When something goes wrong in one study, how can we make sure that learning is transferred to other studies? How can we ensure that knowledge doesn’t walk out of the door when our own employees or our vendor’s employees move on? Where is this knowledge stored, updated, documented and propagated through the organization for future studies? How critical are knowledge management risks? We heard a story about the way a lab manual was written. It was confusing to the sites and a critical sample was incorrectly captured. It caused the sponsor and CRO to waste so much time, energy and frustration digging in to find the root cause. It was a very simple fix but cost everyone money. It was very inconvenient for sites and patients.
Sponsors require early cross-functional collaboration to proactively reduce study risks. They don’t want to see or hear about another blinking light.
Do we get all key stakeholders together before the protocol is finalized to ensure that the risks are identified and discussed? Do we take enough time to properly conduct these meetings? Do we take the feedback to heart and modify the protocol? Do we document the risks and mitigations? How great would life be if we electronically captured the risks and mitigations and were able to ensure 100% implementation of them after the study started? We heard several stories about protocols being finalized without clinical operations input or review. It had a significant impact on employee morale, longer timelines and additional money spent on the study
Sponsors’ are ultimately responsible, so they want tighter controls with their CRO partners.
How do we deal with the incredible turnover of staff at our CRO partners? How do we ensure that they are doing what we expect of them? We need to find ways to work better and ensure that there are controls in place to ensure that we are getting the quality we expect. Can we set expectations and work to them before it gets escalated to our oversight committees? We heard about projects where turnover is in the hundreds of percent in a year. While there are some fantastic CROs out there we hear about the ones where the turnover is rampant and that adversely affects the quality of the study and the relationships with the sites.
Mid-level sponsors need senior leadership’s buy-in.
How can we convince senior leadership that we need to increase quality early on by taking the time to work through things and have the resources to manage our studies effectively? How can we convince senior leadership to deploy key stakeholders to support the clinical team before the protocol is finalized? How can senior leadership help us reduce the amount of administrative work when outsourcing? How do we set the right expectations with our outsourced partners, so we can focus on more active oversight? We heard multiple stories that senior leadership makes a big difference when sponsors and vendors work most effectively together. Senior leadership is critical in setting the right tone and expectations with vendor partners.
HOW WE CAN HELP…
At Kestrel Biologic, we are passionate about helping clinical operations run more efficient trials that are ICH GCP R2 compliant. Through our iQROS™ platform and our embedded risk manager on every study, we can significantly reduce or even eliminate many of the pain points that sponsors are dealing with today. Together, we will make a difference. Let’s chat. Call us at +1 (949) 200-8885 or send an e-mail to firstname.lastname@example.org.