Saama continues our new blog series, “Saama to the Rescue,” in which we profile common, real-life challenges encountered by various levels of clinical trial leadership every day, and how Saama solutions can pave the way for more efficient and effective clinical operations.
We recognize that, in any clinical study, trial leadership at every level have an abundance of details to manage, people to supervise, deadlines to meet, and budgets administer, among other things. What trial leadership does not have is an abundance of time to solve the inevitable challenges that arise in relation to these various moving parts. Saama can help.
Our third installment focuses on a fictional Data Manager in a trial start-up scenario.
Situation: Hi, I’m Bill, Data Manager at ABC Biotech. I got the word today that my company is going to spin up a new trial for one of our investigational compounds for breast cancer. It’s the second one we are starting this year for that particular compound and therapeutic area. I’m charged with the initial onboarding process to get this new trial set up so it runs smoothly.
Challenge: Frankly, our company’s track record when it comes to onboarding trials could be better. Historically, the process has not gone smoothly. Establishing the metrics and KPIs, and accommodating new updates has taken weeks of manual inputting and troubleshooting in the past, causing friction, delays and frustrations. However, this time around I am a bit more hopeful. Just a few months ago, we implemented Saama’s Life Science Analytics Cloud (LSAC) for the first time, deploying it for the first breast cancer study I mentioned. LSAC performed well on its debut effort, so I am cautiously optimistic for round two. We’ll see.
Solution: I log into LSAC and am able to utilize the templates we created for the first breast cancer trial, which puts me ahead of the game right off the bat. So far so good. I migrate over the common metrics from the first trial, and proceed to tweak the established KPIs to customize them for this study. I am pleased to find that I can easily access data sources from CTMS and EDC systems connected to LSAC from the first time around, and that onboarding new CROs is trouble-free, and not the complicated process I recall from the company’s pre-LSAC days. One of the many features I like about LSAC, and which I know will save my company money and me time, is LSAC’s data quality checker. In the past, if we weren’t happy with the quality of data being sent from CROs, it meant lengthy and multiple calls and/or emails to unravel and course-correct. The data quality checker greatly reduces this potential problem by flagging loading issues. We can now easily and quickly hold the CRO accountable for the data quality standard they are contractually obligated to provide.
My IT colleague Mark, with whom I have a good working relationship, stops by to see how it’s going. Mark and his team have been very supportive of the LSAC deployment, as it furthers the company’s business strategy and aligns with his group’s mission of a leveraging state-of-the art solutions for a lighter but more effective technology footprint. Mark says he is very pleased that LSAC eliminates the traditional need for a whole other IT process to inbound new data, and is comfortable with LSAC’s impressive security processes. I value his opinion and agree with his perspective.
Summary: LSAC made onboarding this new trial a completely different process than what I have historically experienced. LSAC expedited and economized every aspect of trial spin-up, saving my company time and money, and me a whole lot of frustration and unproductive effort. I’m confident that LSAC will enable the trial to continue as it’s started, since a successful trajectory is in place. My apprehensions about the roadblocks I traditionally encounter during trial start-up have evaporated, thanks to LSAC.
To learn more or request a demo of Saama’s Life Science Analytics Cloud, click here. “Saama to the Rescue” will continue next week, when we examine the experience of a Central Monitor and how LSAC alters that experience.
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