Founded in 2012, Fidelis Research, a privately-owned life science company provides high-quality human tissues and bio-fluids specimens along with de-identified patient related information to pharmaceutical, biotechnology, and pre-clinical contract research companies to facilitate their research. Fidelis has collection sites in southeast Europe – Bulgaria, Romania, Croatia, Serbia, and Turkey. Through these sites, the company identifies subjects, obtains consents, and then collects various types of samples. Additionally, the company provides services including tissue processing and analysis, cell isolation, lab services and scientific consulting.
The specimens provided by Fidelis Research are used for:
1. Identifying the cause and mechanism of action of diseases
2. Identification of disease-relevant genes or mutations
3. Development of new drug molecules
4. Biomarker discovery in drug development
5. Companion diagnostics development
Data Management Challenges
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. Fidelis Research works on multiple collection studies for different clients, collecting samples from several subjects and sites. Fidelis Research was utilising spreadsheets for managing and tracking the samples, donors, and associated data such as medical history, physical examination, etc. With this manual record-keeping and tracking, Fidelis Research was facing several challenges:
- More amount of time was required to enter the data manually in spreadsheets.
- Validating test results and ensuring quality control.
- No real-time inventory management in terms of storage locations and availability of samples, kits, and materials.
- Difficulty in the tracking of shipments and packages.
- Inconsistency in data presentation and usability for reporting and billing purposes.
- Traceability of results.
- Inefficient use of manpower.
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.
To replace the spreadsheet with an automated solution to provide its customers with integrated services ranging from pre-clinical to market authorization stage of product development.
Comply with the EU Directives, FDA regulations, and the applicable national laws and ensure data security. Shorter turnaround times for processing samples storage, shipping, data management, and billing, all at no capital expenditure.
To overcome these challenges, they decided to implement an automated system. A system that will not only track specimens, but also maintain the clinical and demographics metadata, manage inventory, kit shipments, and test data.
Cloud-based System to Manage Human Tissues, Bio-Fluids, and Medical Study Data
Veselin Stefanov, CEO, Fidelis Research and Iliyan Hristov, Business Development Manager contacted the CloudLIMS team specifying their data management needs. CloudLIMS team presented a detailed product demonstration in line with the required workflows.
The team explained how CloudLIMS could facilitate Fidelis Research in organizing and integrating heterogeneous samples and clinical data, in standardizing processes, and in collaborating securely. Additionally, they also demonstrated how CloudLIMS could help meet regulatory requirements such as HIPAA, GLP, and EU Directives.
Additionally, a SaaS LIMS in the cloud system offers benefits such as enhanced security, rapid scalability, and dynamic allocation of services. Besides, the cloud platform fosters collaboration between collection sites located in different geographical locations, by using a shared environment.
After a thorough evaluation of CloudLIMS and learning the operational and service benefits offered by the cloud-based LIMS over a traditional LIMS such as no upfront costs, secure infrastructure, data privacy controls, and easy deployment, Fidelis Research decided to implement it.
CloudLIMS is an excellent data management solution to manage samples along with their clinical data, which helped us to provide high-quality human tissues and bio-fluids specimens along with de-identified subject associated information to contracting sites, facilitating their research.
– Fidelis Research
Benefits Gained by Fidelis Research
Having a cloud-based LIMS deployed, Fidelis Research has gained the following benefits:
- They are now able to manage and store human tissues and bio-fluids specimens data collected along with the donor information such as age, gender, diagnosis, date of surgery, medical history, etc with appropriate access privileges.
- Data entry is effectively audit-trailed and assures higher compliance of collected data.
- With a cloud-based system, sharing specimens’ data internally and externally became efficient, saving significant and valuable time for both operational and business development resources.
- Data is stored online, easily accessible and regularly backed-up, strong security measures in place.
- Fidelis Research’ clients have benefited from the availability of data in real-time, accurate reports, and faster turnaround times.
Overall with the clinical research LIMS implementation, Fidelis Research has achieved improvements in the company’s operations ranging from shorter turnaround times for processing samples storage, shipping, data management, and billing, all at no capital expenditure.