During SCOPE 2024 in Orlando, Dawn Kaminski, vice president of business development operations at eClinical Solutions, shared valuable insights into the company's latest innovations and their impact on the industry.
Kaminski, with over 25 years of experience in the field, outlined eClinical's commitment to revolutionizing clinical trial operations through their platform, the eClinical Data Cloud. In this exclusive interview, with Outsourcing Pharma, she highlighted the platform's role in accelerating processes and ensuring data integrity across trials.
“We are dedicated to leveraging technology to drive efficiencies in clinical trial management,” Kaminski stated. “Our platform, the elluminate Clinical Data Cloud, offers a comprehensive solution to optimize various aspects of trial conduct, from data collection to analysis.”
Kaminski emphasized the platform's ability to reduce cycle times significantly, citing examples such as database lock within two weeks, a process that traditionally took six to eight weeks. This acceleration is attributed to eClinical's continuous data-cleaning approach, which contrasts with the batch-cleaning method used by many in the industry.
“We pride ourselves on our proactive approach to data management," Kaminski explained. “By reconciling external data sources daily and maintaining real-time visibility for sponsors, we ensure that trials progress smoothly and efficiently.”
In addition to speeding up processes, Kaminski says eClinical's platform integrates cutting-edge technologies like artificial intelligence (AI) to enhance data review and anomaly detection. She highlighted the platform's AI models, which map to various data review objectives, allowing for targeted analysis and risk mitigation.
“Our AI-powered anomaly detection capabilities enable early identification of potential issues, enabling proactive intervention. This proactive approach is essential for maintaining data integrity and minimizing risks throughout the trial lifecycle.”
Another key feature of eClinical's platform, she says, is its risk-based quality management software, designed to mitigate risks as trials progress. Kaminski underscored the importance of proactive risk management in ensuring trial success and avoiding surprises at trial endpoints.
“By using our risk-based quality management software, sponsors can identify and address potential risks in real-time, minimizing the likelihood of delays or deviations. This proactive risk mitigation strategy is integral to maintaining trial integrity and achieving regulatory compliance.”
Reflecting on industry trends, Kaminski acknowledged the growing complexity of clinical trial data, driven by factors such as the proliferation of digital health technologies and the increasing volume of real-world data. She emphasized the importance of embracing these data sources effectively to derive meaningful insights and drive decision-making.
“The clinical trial landscape is evolving rapidly, with advancements in digital health technologies and the availability of real-world data. To stay ahead, organizations must adapt their processes and leverage technology to manage and analyze diverse data sources effectively.”
Looking ahead, Kaminski is optimistic about the future of clinical trials, fueled by continued innovation and collaboration within the industry. She highlighted eClinical's commitment to staying at the forefront of these developments, with a focus on delivering solutions that address evolving industry needs.
“As the clinical trial landscape continues to evolve, we remain committed to driving innovation and delivering solutions that empower organizations to conduct trials more efficiently and effectively. By harnessing the power of technology and embracing collaboration, we can overcome challenges and drive positive change in the industry.”
In conclusion, Dawn Kaminski's insights shed light on eClinical's ongoing efforts to keep ahead of clinical trial operations through creative technologies and proactive risk management strategies. As the industry embraces digital transformation, Kaminksi says platforms like the elluminate Clinical Data Cloud are poised to play a crucial role in shaping the future of clinical research.
