Chatbots in Clinical Research: Improving Communication and Compliance

Clinical research is fundamental to advancing medical knowledge and developing new treatments. However, it often faces significant challenges related to participant communication and regulatory compliance. Traditional methods of communication can be inefficient and costly, while ensuring compliance with complex regulatory frameworks is demanding. Chatbots, powered by AI technologies, are emerging as a powerful tool to address these challenges, offering real-time, personalized interactions that improve the overall efficiency and effectiveness of clinical research.

1. Welcome Chatbots in Clinical Research: Improving Communication and Compliance Madasu Archana M. Pharmacy 047/052024 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Chatbots in clinical r esearch How c hatbots can solve the data problems in clinical trial management Enhancing patient r ecruitment with AI-powered a utomation Equip team members with actionable information, quickly Use cases of chatbots in clinical t rial e cosystem How c hatbots c an i mprove CRF c ompletion ? Limitations of c hatbots Conclusion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2

3. Chatbots in c linical r esearch Chatbots are computer programs designed to simulate conversation with human users. In the context of clinical research, chatbots can serve several purposes Patient Engagement Education and Information Data Collection 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3

4. How c hatbots can solve the data problems in clinical trial management? Challenges in c linical s tudies Throughout the life of a clinical study, various stakeholders, including research associates, site coordinators, principal investigators, and patients, deal with a substantial amount of data and communication. Importance of efficient d ocument m anagement Executing, collecting, recording, and filing trial documents is crucial for the progression of clinical trials, as the information they contain impacts the study's advancement. Competing p riorities for clinical t rial t eams Clinical trial teams handle numerous tasks, from patient screening and onboarding to ensuring compliance and monitoring patient progress . 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4

5. How c hatbots can solve the data problems in clinical trial management? Implementing chatbots in clinical r esearch AI-powered platforms streamline processes for patients and trial administrators by offering interactive interfaces, integrated cloud storage, intelligent document processing, and centralized knowledge bases. Benefits for stakeholders Patients benefit from easier trial information access and enrollment processes, while trial team members enhance efficiency in patient selection, site compliance, and trial analysis tasks. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Enhancing p atient r ecruitment with AI-powered a utomation The traditional recruitment process in clinical trials often begins with a basic informational website, which provides details about the study but lacks interactivity to gather detailed patient information. Implementing an AI-powered conversational chatbot can revolutionize patient recruitment strategies in clinical trials . The AI chatbot engages prospective patients directly on the recruitment website, providing instant responses and collecting necessary information to determine if they meet trial criteria. By automating initial interactions and pre-screening processes, AI reduces the time and effort spent by trial team members on qualifying candidates, ensuring a more focused and efficient recruitment effort. By enhancing patient engagement and qualification processes, AI support automation facilitates faster recruitment and improves retention rates, ultimately advancing clinical trial objectives. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6

7. Equip team members with actionable information, quickly Timeliness and accessibility for clinical r esearch a s sociates Leveraging AI-powered s upport a utomation Customized w orkflows and RPA integration Intelligent document p rocessing for enhanced e fficiency Continuous improvement through feedback l oops Ensuring security and privacy in support a utomation Access control and data p rivacy m easures 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Use cases of c hatbots in clinical t rial ecosystem 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8

9. How c hatbots c an i mprove CRF c ompletion ? A case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study-specific data. While CRF completion guidelines refer to a clinical document to assist the investigator or site personnel to complete the CRF in a step-by-step manner and is drafted concurrently in line with the CRF and protocol . Every time when the site enters the data in the EDC System, they have to refer to the CRF completion document or click on the embedded links in the EDC system before entering the data in the EDC system . 10/18/2022 www.clinosol.com | follow us on social media @ clinosolresearch 9

10. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10 How AI- c hatbots c an i mprove CRF completion ?

11. The limitations of c hatbots in clinical t rial d ata s ystems Regulatory compliance Privacy and security concerns Integration challenges Limited customization Limited awareness and adoption 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11

12. Conclusion AI-powered chatbots offer significant potential to improve the patient experience in clinical trials. By enhancing communication, data collection, and compliance, they contribute to more efficient and patient-centric trial processes. However , successful implementation requires careful consideration of design, integration, and ethical aspects. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 12

13. References https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10720846/ https://www.pharmaceuticalcommerce.com/view/chatbot-potential-in-clinical-research https://www.cloudbyz.com/resources/clinical-operations/how-chatbots-can-be-employed-in-clinical-trials/ https://www.linkedin.com/pulse/streamlining-data-collection-clinical-trials-how-ai-talisetty-ccdm-/ 13

14. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 14