Sample management is a key part of the laboratory management of CRO new drug R&D companies, but there are four major problems in traditional sample management, such as errors, manual input to Excel is prone to manual errors and input errors, which reduces the accuracy and completeness of sample data; Sample traceability is difficult, and traditional samples need to be manually classified, numbered and manually registered, and the traceability efficiency is extremely low; The third is the lack of standards and processes for sample management, and the difficulty of departmental collaboration; Fourth, it is very important, that is, data security and privacy issues, the Excel format lacks permission control, which is easy to cause data leakage and security risks.
Benefiting from the continuous development of digital technology, CRO new drug development companies also hope to achieve higher efficiency of sample management, lower error rate and full-process tracking of sample management by implementing digital sample management transformation. However, the particularity of the CRO industry has brought new problems, digital systems must follow GLP specifications, through computerized system verification (CSV), enterprises such as choosing commercial software (according to GAMP5 regulations: category 3, non-configurable software), can easily pass CSV verification, but commercial software functions are difficult to fully match the requirements. If enterprises want to meet the actual requirements, customization is a solution, but the development cost of the customized system is large and the time is long, and because the customized system belongs to category 5 (customized development software) stipulated in GAMP5, it needs to pay a professional third-party organization for verification, and the verification is a one-time fee, and each modification and upgrade needs to be paid separately. All things considered, neither of these approaches is a suitable solution for CRO new drug development companies to carry out the transformation of digital sample management.
Is there any solution that can perfectly solve the above problems? Let's take a look at whether the approach of a large CRO pharmaceutical R&D company can bring you inspiration.
It is a large-scale CRO pharmaceutical R&D company that provides integrated, end-to-end new drug R&D and manufacturing services for the global biopharmaceutical industry, covering Asia, Europe and North America, covering chemical drug R&D and manufacturing, biological research, preclinical testing and clinical trial R&D, cell and gene therapy R&D, testing and manufacturing. Its digital transformation work has not been smooth, mainly due to the backward overall digital level of the industry, GLP standard control and computerized system verification problems.
The company introduced a configurable digital platform from a domestic software company, and since the platform falls into category 4 as stipulated in GAMP5, it only needs to be self-verified; At the same time, based on the platform, the company's personnel do not need to write code, and can build system applications in various business scenarios only by configuration, which can greatly shorten the development and verification cycle.
In the application, the company positioned it as a digital information processing platform to help gradually realize the digital transformation of the laboratory business, the company first built a sample digital management system that meets the actual needs, and after the system was launched, the company has achieved significant management results in sample management. Subsequently, the company continued to expand the scope of use of the platform, and successively built many laboratory scenarios including project management, project scheduling, archive management, automatic writing of Excel reports, document review and collaboration, etc.
What is this configurable digital platform? Why can it easily solve the digital management problem of CRO new drug development companies?
Speaking of which, I won't sell it. The platform is a configurable digital platform for the Rubik's Cube netlist launched by Beijing Rubik's Cube Hengjiu Software, which has been recognized and used by 150,000+ enterprise users.
To meet the needs of CRO new drug R&D companies for digital sample management, the Rubik's Cube netlist has the following unique advantages.
Rich GLP features and components, self-verification can be compliant
Fully in line with the requirements of GLP specifications, providing a rich component library, which can be used by CRO pharmaceutical R&D companies to build a sample digital management system in line with GLP specifications according to actual needs, the platform belongs to category 4 specified in GAMP5, only self-verification is required, and the Rubik's Cube netlist also provides CSV verification assistance services to assist efficient and fast verification, and the platform also has an audit diary function for pharmaceutical companies to use retroactively.
Flexible customization of sample management templates to meet the needs of various scenarios of the company
CRO pharmaceutical R&D companies can flexibly configure and quickly customize sample management templates, and the sample digital management system can also track the detailed information of different samples at any time, including sample source, sample collection date, processing method, etc. At the same time, because the Mosaic netlist is a configurable digital platform, the company can also quickly implement the modification and expansion of the system according to its own needs.
Standardized and transparent sample management process, one-click query of sample status
The BPM process module of the platform is deeply integrated with the form, which can be used by CRO pharmaceutical R&D companies to create a standardized and transparent sample management process, and support convenient functions such as automatic circulation, automatic reminder, and automatic reminder. It can also track the whole process of the sample and query the status with one click, including the sample location, sample status, flow process and processing process.
Perfect permission control, zero sample data leakage
Sample data security is indispensable for CRO pharmaceutical R&D companies. The Mosaic netlist provides flexible permission control functions, which can be used by the company to implement different use and viewing permissions according to the level of business implementers to ensure the security and controllability of sample data.
Seamlessly connect with other systems in the laboratory to improve the efficiency of collaborative office
With the industry's original "external field group", the sample digital management system based on the Rubik's Cube netlist can be seamlessly connected with internal and external software and hardware such as laboratory information management system (LIMS), electronic data capture system (EDC), experimental instruments, etc., which can realize a variety of complex operations such as task execution, data synchronization and data collection, and improve the efficiency of the company's internal collaborative office.
Visualized sample data display for efficient management and scientific decision-making
The platform has a powerful built-in data analysis and display function, including dozens of chart modes, which can be used by CRO pharmaceutical R&D companies to quickly find key indicators such as sample quantity, sample status and process, and can also realize multi-dimensional display of sample distribution, trends and changes and other information, so that enterprise managers can formulate scientific and efficient sample management strategies, and can also provide data support for important decisions for senior management.
Other CRO industry use cases for Mosaic netlists:
Shanghai Taichu Group
Headquartered in Life Blue Bay, Lingang New Area, Taichu Group has a number of subsidiaries, including Taichu Biotech, etc., and its business includes non-clinical druggability evaluation (CRO), antibody drug construction and production (CRO/CDMO), R&D of pharmaceutical preparations, CDMO and other service types. Relying on the Rubik's Cube netlist, Taichu Group has built a group-level enterprise internal management platform, and makes full use of the Rubik's Cube netlist audit trail feature of historical records and operation behaviors to carry out the practice of GLP management related applications.
Shanghai Model Organisms
Shanghai Nanfang Model Biotechnology Co., Ltd. (hereinafter referred to as SMOC) has built the company's business management system through the Rubik's Cube netlist, and gradually realized the digitization of all the company's business processes. The business includes: cell management, embryo management, mouse management, large animal management, sales management, order management, pharmacodynamic experiment library, target cloning system, etc. Diversified query and filter functions can easily find the information you need.
If you are a veteran in the CRO industry, or your company happens to be facing the problem of digital management of samples, you can contact the Rubik's Cube netlist, I believe that direct communication will make you have more gains.