With increasing pressure to overcome drug development challenges and advance drugs to market faster and with greater efficiency, sponsor expectations of CROs and their services are running high.

Addressing challenges leveraging innovative technology solutions to enhance clinical trial processes and improve data quality and integrity, increasingly relies on tools such as risk-based quality management and embracing artificial intelligence (AI) to improve efficiencies.

Patrick Hughes, Co-Founder and Chief Commercial Officer at CluePoints shares insight on how the adoption of new tools and technologies will be key to CROs and the services they provide. 

Contract Pharma: What are the pharma/biopharma R&D trends impacting CROs and services?

Patrick Hughes: As an enterprise SaaS company that sells autonomous software solutions to CROs and Pharma companies, we are seeing increasing pressure from the industry to enhance clinical trials processes. This is being supported by the adoption of innovative technology solutions and improved practices among certain CROs.

However, it risks being undermined by a third trend – the impact of workforce reductions and cost-saving implications in some CRO organizations. 

Contract Pharma: Where do you see the most growth in outsourcing? 

Patrick Hughes: Now that we are past the point of early adopters, we are seeing a growth in risk-based quality management (RBQM) being delivered by CROs on behalf of the sponsors they serve. There is momentum as the industry sees the benefits and understands why regulators brought this in. 

A survey by the Tufts Center for the Study of Drug Development published in February 2024 found 78% of respondents trust RBQM will improve the overall quality of research and 63% trust it will enable efficiency and cost savings.

To take advantage of that, CROs who work with us on a regular basis are making RBQM a standard element in their delivery of services to their Biopharma customers allowing them to realize the efficiency benefits that everyone, including the regulators, are expecting. 

Contract Pharma: What are the technology trends impacting clinical trials today?

Patrick Hughes: More efficient use of technology is enabling smarter clinical trials. We are seeing solutions which enable better operational and cost efficiencies and automation to reduce labor-intensive manual tasks.

There is an expectation from pharma that CROs and other partners will harness the power of artificial intelligence (AI) to improve how clinical trials are run. For example, combining machine learning (ML) and natural language processing (NLP) to help with repetitive but essential tasks like medical coding and risk detection.

Contract Pharma: What are some of the key issues impacting Sponsor/CRO relationships? How can CROs improve partnership models?

Patrick Hughes: Sponsor oversight of CROs has become a lot more pertinent over the last 12 to 24 months. The final FDA guidance on risk-based approaches to the monitoring of clinical investigations published in April 2023 reinforced the importance of sponsor oversight.

In terms of improving partnership models, the best CROs truly understand the end-to-end process and the implications of the technology they are implementing to reduce manual processes and duplication in their work.

Improved efficiencies equal: reduced costs, reduced work internally at the CRO and at sites and quicker timelines. Ultimately, this leads to a better experience for everyone involved in drug development, increased speed to market and better outcomes for sponsors and patients.

Contract Pharma: What are the biggest challenges CRO face in today’s market?

Patrick Hughes: CROs are now realizing that the revenue streams of monitoring and source data verification (SDV) are not sustainable. They need to adopt processes like RBQM and technologies utilizing ML to make their processes and people more efficient. CROs need to adopt a macro-economic viewpoint, where they accept the loss of some aspects of on-site monitoring and SDV revenue and recognize that if they are delivering efficiencies and savings, a sponsor is more likely to work with them in the future.

CROs cannot just ignore AI. Instead, they need to take a strategic view of how new tools and technologies are going to change the way they deliver their business. Those that do so will be able to deliver efficiency. Those that do not will face a real challenge.

Contract Pharma: What factors do you anticipate will drive growth in the CRO sector? What factors will challenge growth?

Patrick Hughes: The CROs who are going to thrive are the ones who do things faster, better, and more economically. This is about more than just cutting costs. It is about utilizing the tools available, embracing AI, and getting drugs to market quicker.

Adoption of tools which improve data quality and integrity and have a material impact on the study will be key to driving growth. Once data has been collected it needs to be analyzed and critical thinking applied so when the study gets to submission there are no data quality issues.

In terms of challenges, some CROs might struggle to adapt as this is something they have to face rather than being given a choice. Some CROs will need to change how they measure success. We are already seeing some of the big sponsors holding CROs a lot more accountable on delivery metrics.