In the dynamic field of bioanalysis, Data Transfer Agreements (DTAs) are essential for maintaining data integrity, security, and regulatory compliance across multi-site clinical trials and collaborative research projects. This webinar will provide participants with the knowledge and practical insights needed to develop comprehensive DTAs tailored to the complexities of real-world bioanalysis. The session will begin with an in-depth overview of DTAs, focusing on key components such as data privacy, confidentiality, and regulatory requirements. Participants will gain a clear understanding of the distinct roles and responsibilities of test sites, Contract Research Organizations (CROs), and sponsors throughout the DTA process. Drawing on a real-life case study, our expert speaker, Sibel, will explore common challenges in drafting DTAs, including standardizing bioanalytical data in a multi-site clinical trial, ensuring data security during transfers, and adhering to diverse regulatory requirements. The discussion will offer practical strategies to overcome these challenges, providing attendees with actionable solutions. This webinar is designed for clinical research, data management, and regulatory affairs professionals looking to deepen their understanding of DTAs and enhance their skills in developing effective agreements that ensure seamless data transfer and compliance in bioanalysis.

You Will Learn:

• Gain a comprehensive understanding of the essential components of a Data Transfer Agreement (DTA).
• Enhance awareness of common challenges in data transfer, such as standardization, security, and regulatory compliance in multi-site clinical trials and collaborative research projects.
• Improve skills in identifying and resolving potential issues in DTA negotiations.

Sibel Ahmedova is a Project Manager at Bioanalysis and Services at Mercodia, specializing in overseeing service projects within the bioanalysis and service department. With extensive experience in project management and LIMS system administration, she is responsible for evaluating quotes and agreements, managing customer interactions, and ensuring that projects fulfill their intended use. Sibel leads, monitors, and reports on service projects while coaching and assigning tasks to team members. She is critical in resource planning, regulatory compliance, and continuous improvement, representing the Bioanalysis and Services team at external meetings and acting as a Principal Investigator in GLP studies.