How to Automate Your Clinical Study Build

Written By Manasi Kaushik, Marketing Manager

Last month I lost a friend of mine to ovarian cancer. While I hadn’t been in touch with her in the past few years, I did often think of her and always thought she was going to do amazing things in life. So safe to say, this news came as a shock to me. Later, I learned that there is no cure for ovarian cancer and that there are ongoing studies to find a cure but that this may take years. A primary cause of this delay, I’ve come to understand, is the amount of time a clinical trial process takes.

This market gap presents an opportunity for companies to use technology and innovation to develop solutions to accelerate the clinical trial process. Hence, I was looking forward to speaking with Kedar Deshpande (KD) who is the Senior Director for Clinical Data and Analytics at Fresh Gravity and has been working in this space for over 17 years. In this piece, we learn about Kedar’s perspective on how innovation and technology can help significantly fast-track the clinical trial process.

MK: For the benefit of anyone reading this blog, can you explain what CSAT (Clinical Study Automation Tool) is? 

KD: CSAT or the Clinical Study Build Automation Tool is an end-to-end platform built to design and develop all the components of a clinical study build process in a single click.

Essentially, CSAT is a one-stop solution for all things related to a clinical study including the clinical protocol document. CSAT uses innovation as well as leverages the latest technologies to make the clinical study build process faster, and more efficient while ensuring improved quality.

This tool utilizes Natural Language Processing (NLP) and Machine Learning (ML) to extract the contents of the protocol and auto-predict, recommend, and generate the set of eCRFs (electronic case report form), edit checks for the study protocol, along with generating an EDC (Electronic Data Capture) importable file. The tool also auto-generates the SDTM (Study Data Tabulation Model) mapping and SDTM executable program to ensure the data transformation is complete.

MK: What, according to you, is the need for it?

KD: The current way of designing a clinical study is manual, skill-dependent, and resource-intensive.

According to clinicaltrials.gov data, there are 40K+ new clinical studies conducted each year and for every trial 14 weeks are spent just on the study build for EDC. The manual effort for each study build could amount to 700-man hours, not to mention the steep costs.

Fresh Gravity’s CSAT can help reduce the effort by 80% thereby saving around 500-man hours per study. If we were calculating for a sample of 300 trials, 150k hours would be saved which could also translate into saving 1 million dollars, thereby increasing productivity and profitability.

MK: Who can benefit from this tool and how? 

KD: In my opinion, all CROs (Clinical Research Organizations), Pharmaceutical companies, FSP partners, and Bio-Tech companies stand to gain from the CSAT tool. In the long run, it will also be beneficial to patients.

The benefits of the tool are two-fold:

• Faster go-live, which means earlier First Patient In (FPI) and faster availability of the SDTM datasets for analysis
• Niche skilled people can utilize their time more efficiently by focusing on the complicated things to be handled in the process of clinical trial

MK: What has been the most exciting part about working on this solution?

KD: What really drives me and is also the most exciting part for me is helping make newer medicines and drugs available to humankind at a faster pace. By bringing in innovative technology, we are helping bring new drugs to market faster.

MK: What are some of the things you are looking forward to in 2023 in terms of how CSAT could evolve/be a game changer?

KD: I believe that CSAT is going to be a game changer and will bring disruptive changes to the industry by drastically reducing the time it takes for some of the key processes in a clinical trial. I am looking forward to seeing the clinical industry adopt this kind of automation much like other industries have been doing for over a decade and are reaping the benefits.

MK: How can Fresh Gravity help in bringing about this change?

KD: By partnering with an increasing number of pharma companies, together we can revolutionize the way clinical trials are conducted and significantly reduce the go-to-market time and cost of drugs, which eventually will benefit patients in need of these medicines.

To learn more about CSAT, please write to Kedar Deshpande at kedar.deshpande@freshgravity.com or click here to read more.