Sector Report

Here is our “deep dive” report on the use of information technology in clinical trials following a series of discussions with top executives at leading software vendors and private equity firms. In our view, there is a broad understanding that integrated software/technology platforms can lead to accelerated timelines, enhanced quality, greater efficiencies, and improved collaboration in drug development and clinical research.

Key Takeaways

1. We see a positive regulatory environment under a second President Trump administration. In particular, software vendors selling into the clinical trial space will likely benefit from a less regulated environment for artificial intelligence. Also, Trump will likely be significantly less antagonistic to healthcare mergers and acquisitions than the outgoing Biden administration.
2. Updates to the ICH E6 guidelines will bring greater focus on “quality-by-design” and “risk-based quality monitoring” concepts in clinical trials. Over time, this should have the effect of encouraging sponsors and CROs to bring in software/tech vendors earlier in the clinical trial design process — rather than “forcing” vendors to fit to a protocol after it is developed.
3. Clinical trial complexity continues to increase due to more nuanced science, novel therapeutic modalities, and the greater use of precision medicine — as well as pressure on pharma companies to differentiate their products based on “quality of life” measures. This, in turn, is driving demand for unified software/tech strategies to improve data quality.
4. The biopharma industry remains a large and attractive end market for software vendors to sell into. Advances in molecular biology are creating new opportunities for drug development, and the pharma industry is under significant pressure to develop new revenue streams to offset more than $180 billion of revenue that is “at risk” from patent expiries through 2030.
5. Platform vendors generally outperform. Simply stated, integrated software/tech platforms allow sponsors and CROs to work off of a single dataset in real-time, mitigating the risk of lost and erroneous data that can occur as a result of double-data entry and the interfacing of disparate software applications. This, in turn, reduces costs, improves decision-making, and accelerates “time-to-market” for the end user.

In the dynamic healthcare industry, staying ahead of trends is essential for informed decision-making and seizing opportunities. Please reach out to our research team for more information.