CRO Summit Chair Muses On The Future Of CROs
A conversation with Jasmina Jankicevic, MD, MSc, CCRP
Jasmina Jankicevic, a seasoned CxO in the biopharma industry and chair of the upcoming Clinical Outsourcing Group CRO Summit, shares her insights on the evolving landscape of CROs. In this wide-ranging discussion, she explores how emerging technologies like blockchain, IoT, and artificial intelligence are transforming traditional clinical trial models, while emphasizing the growing importance of real-world evidence and patient-reported outcomes. Jankicevic offers a forward-looking perspective on how these innovations will reshape the relationship between biopharma companies and CROs, particularly in the context of precision medicine.
Clinical Leader: How do you expect the increasing adoption of decentralized clinical trials to impact traditional outsourcing models in the biopharma industry?
Jasmina Jankicevic, MD, MSc, CCRP: We have yet to optimize a decentralized approach to clinical trials. It will never be one-size-fits-all, but with the significant uptake in employment of technology in clinical research and decentralized principles, opportunities will evolve significantly to meet demands for patient-focused clinical development.
I expect to see growth in utilization of technology to facilitate many aspects of clinical studies, including global recruitment of diverse patient populations, remote patient consenting, continual patient monitoring, data collection, and data monitoring. Consequently, the roles of CROs may shift from traditional site management to more technology-focused services, such as data analytics and remote patient engagement. This will have to be coupled with new CRO expertise in navigating global regulatory landscapes for decentralized methods.
I can foresee both sponsors and CROs partnering with technology companies for digital solutions to secure robust data management and cybersecurity strategies. Of course, cost reduction will be part of the equation and will prompt innovation to streamline CRO services.
What role do you see emerging technologies like blockchain and the internet of things (IoT) playing in reshaping clinical outsourcing strategies over the next few years?
Most of us are still learning about blockchain and IoT capacities in the context of clinical research. The areas where I could see significant opportunities to leverage them are all decentralized activities, overall enhanced data integrity, and security of patient data during collection, transmission, and management. The same rigor could be applied to streamline supply chain management, especially the logistics of optimized drug/device preparation, tracking, and delivery.
The other big area applicable across all stages of study implementation and auditing is smart documentation generation and management to reduce administrative burden and timelines. It will be very important to continually investigate and show cost-effectiveness of employment of blockchain and IoT to secure prompt and wide adoption.
How might the increasing focus on real-world evidence (RWE) and patient-reported outcomes (PROs) affect the scope of services that biopharma companies outsource?
The focus on RWE and PROs will continue to grow and have a significant impact on the scope of services that biopharma companies choose to outsource. Companies will increasingly seek partners that can collect and analyze real-world data from diverse sources, such as electronic health records, insurance claims, and patient registries to inform their clinical development and market access strategy, as well as planning and design of every study on the path to regulatory approval and successful commercialization. This will require outsourcing services to companies that specialize in data analytics and integration, accompanied by knowledge of regulatory compliance. The PROs are integral to patient-focused clinical development and their impact on the outcomes of development programs will continue to grow. Consequently, we will need more indication-sensitive, validated PRO tools, as well as optimized ways to engage patients and collect reliable PRO data. That is an opportunity for vendors to specialize and differentiate themselves.
In what ways do you anticipate AI and machine learning will influence the division of responsibilities between sponsors and CROs in clinical trials?
Proper utilization of AI and machine learning (ML) has significant potential to advance clinical research. It will likely lead to a more flexible and collaborative division of responsibilities between sponsors and CROs. Sponsors will maintain strategic oversight, but CROs may take on expanded roles in data management, operational efficiency, compliance, and patient engagement, leading to a more efficient and effective trial process overall.
For example, CROs may use AI to improve patient recruitment strategies by analyzing large data sets to identify eligible participants more efficiently. Similarly, with ML, algorithms could be developed to help analyze patient engagement and retention patterns, allowing CROs to implement targeted interventions. Also, CROs could be taking on more responsibilities in risk and outcome predictive analytics, continuous monitoring of trial data to identify trends, and real-time reporting to enhance data quality and empower sponsors’ decision-making processes. Concurrently, AI-driven automated workflows for site selection, monitoring, and reporting could optimize study operations. Another opportunity for CROs equipped with AI capabilities will be to analyze data from multiple trials to identify best practices, share with sponsors, and implement in upcoming studies.
How do you foresee the trend toward precision medicine affecting outsourcing decisions in clinical development, particularly for smaller biotech firms?
Precision medicine movement will likely lead to smaller biotech companies taking a more strategic approach to outsourcing and focusing on partnerships that can provide specialized expertise, advanced study management, and complex analyses of large and diverse data and that are able to cater to multifaceted trial designs. This shift will enable them to navigate the complexities of precision medicine more effectively, ultimately enhancing their capacity to bring innovative therapies to market and to show value that will enable successful commercialization. Sponsors will more often seek partnerships with niche CROs that have expertise in specific therapeutic areas or technologies.
About The Expert:
Jasmina Jankicevic is chairwoman of PBC Group’s inaugural CRO Summit. This meeting of strategy and operational CRO executives is the first of its kind, attracting attendance on an international level, from large, medium and emerging, and specialized CROs to discuss the changing landscape of clinical research.
Dr. Jankicevic is an expert in dermatology drug and device development. She has led clinical development in dermatology and medical aesthetics for CROs, pharma/biotech, medical device, and cosmetic companies, including Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 350+ clinical study protocols in 25+ indications, by leading global cross-functional teams toward successful regulatory submissions, product launches, and innovative life cycle management. As an international KOL in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their paths to global regulatory and commercial successes.