In this interview, we speak with Carolyn Jin, Director of Clinical Systems and Document Management at Kura Oncology. She shares insights into how Electronic Trial Master File (eTMF) systems are transforming clinical trial management, particularly in enhancing outsourcing and partnerships with CROs, improving oversight, and ensuring regulatory compliance.
Moe Alsumidaie: How has eTMF implementation at Kura Oncology improved managing outsourcing relationships with CROs?
Carolyn Jin: At Kura Oncology, we implemented an in-house eTMF system and require our CROs to upload documents directly. By granting them user access, we ensure collaborative management where documents—like the master TMF plan—are co-created with our CRO partners. This fosters better alignment, minimizes surprises, and enhances engagement. As a result, we’ve seen improved efficiency and collaboration metrics, with strengthened accountability and transparency. This integrated approach streamlines document management and solidifies our CRO partnerships, making clinical trial processes more seamless and practical.
Moe Alsumidaie: How does eTMF contribute to oversight, particularly with the FDA’s focus on sponsor oversight?
Carolyn Jin: Our system enables a risk-based approach to oversight. Instead of reviewing every document, we focus on high-risk ones identified in the bioresearch monitoring (BIMO) manual. These are sent to internal functional owners via a workflow we call sponsor oversight quality control (QC). This method allows us to demonstrate oversight without getting bogged down in unnecessary
detail. Concentrating on critical documents ensures compliance while maintaining quality across multiple sites, all without increasing the workload. This risk-based approach allows us to manage oversight effectively, regardless of the trial’s size.
Moe Alsumidaie: As a growing biopharma company, how do you decide between insourcing and outsourcing?
Carolyn Jin: Our model is heavily based on outsourcing and is supported by a lean team. The scalable design of our risk-based oversight approach means we can manage multiple trials efficiently without expanding our internal team significantly. This flexibility ensures that our processes remain efficient, adaptable, and scalable as we grow. It’s about focusing on strategic oversight and leveraging the strengths of our CROs, allowing us to achieve clinical trial goals without unnecessary internal growth.
Moe Alsumidaie: How does eTMF ensure compliance with regulatory requirements while enhancing operational efficiency?
Carolyn Jin: Our eTMF system allows us to design processes with regulatory compliance in mind, such as our structured approach to handling 1572 forms. By clearly defining roles and responsibilities for CROs and our study team, we ensure compliance is integrated into our operations. This structure helps us manage high-risk documents more effectively without sacrificing operational efficiency. By focusing on critical documents and applying a risk-based strategy, we can oversee multiple sites while maintaining flexibility and adaptability to industry changes.
Moe Alsumidaie: How does eTMF enable storytelling in clinical trials compared to traditional paper documentation?
Carolyn Jin: eTMF’s digital capabilities provide a more cohesive trial narrative. It allows us to link documents, track protocol amendments, and add context for changes, making it easier to follow the story of the trial. The ability to search by keywords and consolidate information enhances accessibility, making retrieving and understanding the trial’s history much simpler than with scattered paper documents. This improves operational efficiency and ensures the trial’s story is complete and readily accessible for regulatory purposes.
Moe Alsumidaie: How do you think AI will play a role in eTMF management in the future?
Carolyn Jin: AI has the potential to enhance scalability and efficiency, though we need to address system validation and change management challenges. AI could significantly improve our risk-based approach with appropriate checks, allowing for more human focus on critical points. AI could automate routine tasks, provide insights through data analysis, and even assist in predictive analytics, making the management of clinical trials more efficient and effective. By focusing on a core set of high-risk documents and using a risk-based approach, we can efficiently manage oversight across multiple sites without overwhelming our team.
This content is sponsored by Veeva
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
