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Abstract 5120: Managing human tissues, bio-fluids, and clinical trial data at Fidelis Research leveraging a cloud-based system

Introduction: Founded in 2012, Fidelis Research provides high-quality human tissues and bio-fluids specimens along with de-identified patient disease information to pharmaceutical, biotechnology, and pre-clinical contract research companies to facilitate their research. Fidelis has collection sites in South East Europe - Bulgaria, Romania, Croatia, Serbia, and Turkey. Through these sites, the company identifies patients, obtains consents, and then collects various types of samples. Additionally, the company has also established Clinical Research Units that conducts clinical trials. The primary goal of Fidelis Research is to provide its customers with integrated services ranging from pre-clinical to market authorization stage of product development. To achieve this, a Laboratory Information Management System (LIMS) was indispensable. Description: At any given point, Fidelis works on multiple collection projects for different clients, collecting samples from several subjects and sites. The samples are shipped to the biobank facilities. This requires excellent data management to ensure that the right data is associated with the right samples, thus facilitating their shipping to clients. The main challenges the company faced before implementing CloudLIMS’ solution had to do mainly with the amount of time spent on manually entering data, the difficulties with ensuring the accuracy of data and QC, risks of overlapping or deleting data by multiple users, inconsistency in data presentation and usability for reporting and billing purposes. Results: After deploying the cloud-based LIMS, Fidelis is now able to efficiently manage and store human tissues and bio-fluids specimens collected along with the donor information such as age, sex, diagnosis, date of surgery, medical history, etc. With a cloud-based system, sharing specimens’ data internally and externally has become much easier and hassle-free. Fidelis’ clients have benefited from more consistently presented data, accurate reports, and faster turnaround times. Fidelis has integrated its label generation and printing with CloudLIMS, benefiting the company and its clients. Conclusion: Cloud-based LIMS facilitates Fidelis Research in providing high-quality, ethically-sourced human biospecimens for the research and development needs of pharmaceutical, and biotechnology companies. Additionally, the LIMS also helps Fidelis Research to comply with the EU Directives, FDA regulations, and the applicable national laws and ensure data security. The improvements achieved in the company’s operations range from shorter turnaround times for processing samples storage, shipping, data management and billing, to facilitating auxiliary services such as label generation and printing. Citation Format: Aditi Gade, Arun Apte, Shonali Paul, Iliyan P. Hristov. Managing human tissues, bio-fluids, and clinical trial data at Fidelis Research leveraging a cloud-based system [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 5120.