Regulatory Expertise

Region Uppsala is actively engaged in conducting clinical trials across all medical disciplines. These trials can be initiated by pharmaceutical companies or by the Akademiska sjukhuset (University Hospital). For academic trials where Region Uppsala serves as the sponsor, there is a stringent requirement for regulatory expertise. This is crucial to ensure patient safety, the ethical integrity of the research process, the high quality of collected data, and compliance with all applicable legal frameworks. The need for specialized knowledge in regulatory affairs is paramount to navigate the complex landscape of clinical trial management, ensuring that all activities adhere to national and international standards and guidelines. This includes understanding and implementing Good Clinical Practice (GCP), managing regulatory submissions and approvals, overseeing data management and reporting, and ensuring ongoing compliance throughout the trial lifecycle. The objective is to maintain the highest standards of research conduct, thereby safeguarding participants and the reliability of the trial outcomes. Region Uppsala seeks to bolster its capacity in this area to effectively manage its responsibilities as a sponsor of clinical research, fostering an environment of trust and scientific rigor.

This is a services contract in the health and medical services and Research sectors, with a focus on Research Institutions. Located in Sweden, Europe, this opportunity is open to firms and consortiums, with an estimated budget of SEK 3.5 million.

Published through TED - Tenders Electronic Daily (EU), a national government procurement portal. Public procurement tenders follow the country's national bidding regulations and may have specific eligibility and documentation requirements for services in the health and medical services sector. Service contracts are typically evaluated on both technical quality and price, and may require bidders to demonstrate relevant experience and qualified personnel. This contract has already been awarded. The information is published for transparency and market intelligence purposes.