Lepu Biopharma Co., Ltd. is an innovative biopharmaceutical company with a global focus on oncology therapeutics based in China. It has developed a strong pipeline of oncology drug candidates, including clinical and preclinical ADCs, oncolytic virus drugs and immunotherapies. Through the three rounds model of “independent R&D + strategic cooperation + investment and Merger”, LP Bio has built a series of differentiated pipeline platforms, with its strengths in ADC, which is the first tier in China.
How to solve the problem of SOP system establishment and update in enterprise management and project execution?
In terms of Enterprise Management:
1. Sloppy enterprise management: lack of a solid systematic process and management framework, non-standard management system, SOP formulation may deviate from the actual situation of the company.
2. SOP processes unclear: there are situations not in line with current industry standards, in considering whether the development of SOPs meets the actual situation of the company.
3. SOP diversity: due to outsourcing different CRO companies, most SOPs used are from CRO companies, no internal accumulation of standard SOP; and commissioning studies to a third party is not reliable. Without certain management tools, it is difficult to be informed that the commissioned parties implement in accordance with the standards; have difficulty managing studies.
4. Multiple teams: nearly 300+ people in Lepu Beijing team, Miracogen team, US team, expert team, and CRO team; mixed experience of internal/external personnel, high cost of personnel training; high mobility of personnel, easy loopholes in the management process, affecting study quality.
In terms of Study Implementation:
1. The system is easy to establish but difficult to implement, with limited acceptance of systematization due to the different professional abilities and work experiences of personnel.
2. SOPs do not run smoothly and need to be revised repeatedly during implementation, and the process is lengthy. 3. SOPs updates are frequent and difficult; GCP is not followed and the quality is low.
4. Although the enterprise SOP system is huge and complex, some SOP files are merged, overlapped, and fuzzy. Some content is difficult to search, some folders include too much content, and some departments have different systems with ambiguous content boundaries.
· Hope Taimei help achieve enterprise informatization and systematic management
· Through a self-built system, master study outsourcing data and develop control of data accumulation
· Solve SOP uneven management problems through the system, improve standardization performance, improve the enterprise SOP management library, and reduce personnel training costs
Taimei provides study operation management solutions based on eCooperate Professional system consulting services to organize the workflow system
1. We can help enterprises collect and organize the key information in the early stage of SOP update such as MVR templates, PD classified dictionary, visit issue classified dictionary, and approval workflow; Taimei can customize the modules as follows: site feasibility, site screening, site initiation preparation list, visit initiation, visit routine, visit closure, confirmation letter, follow-up letter, PD report, study communication report, study handover report, site communication report, site handover report, PD list, etc.
2. We can provide professional consulting advice to help clients establish management systems and provide rational modifications to the MVR collection, such as common issues, PD classified dictionary, and unified classification which help form subsequent horizontal comparisons of PD/issue report statistics for all company projects.
3. We can provide reasonable suggestions on task warning and reminder, and establish standard reminder rules and warning mechanisms at the enterprise level, such as the time limit settings of visit reports from submission to approval, and the time limit setting of issue processing.
SOP system construction in CTMS system
1. Various SOP template libraries can be established in CTMS to form a library of enterprise SOP templates; when a new SOP is needed, you may just complete the configuration of data fields, forms, dictionaries, etc. in the CTMS system and apply it to the study with one click, and the SOP can be used immediately or any time you want.
2. CTMS supports the establishment of a standardized auditing workflow, which can be applied to each study with one click, and the processes can also be customized study-by-study to better suit actual business scenarios of studies and outsourcing.
3. CTMS supports setting task warnings and reminders by SOP, task timing/real-time reminders, and automatic calculation of CRA’s KPI by AI to ensure the timeliness and timeliness of task completion.
SOP system maintenance and update
1. CTMS supports SOP template update and the quick revision of form, processes, and dictionary to achieve quick SOP revision.
2. CTMS supports SOP template update, one click to switch to the latest version, worry-free switching; fast and high-quality delivery to the sponsors enhances the core competitiveness of Lepu.
Enabling digital files management at all times
The file collaboration management solution based on “eArchives” , with standardized configuration + customized development,
meets the standardized file management and collaboration needs of international multi-site trials from compliance, completeness,
timeliness, confidentiality, and completes the entire digital management of files generation, collection, approval and quality control,
which helps the company to carry out international clinical trial projects smoothly.
Enabling efficient file collaboration management
The system is designed to be “convenient and friendly”, which is the most intuitive feeling of the clinical trial team. Within a month
of the system going live, the number of files uploaded was 1000+ and the team usage rate was 80-90%. It has significantly improved
the efficiency of Newave team’s file management in international multi-sites projects by 40-60%.
Establishment of an international file management system and smooth operation of the projects
In response to the actual situation that Newave team has multiple sites in multiple countries, Taimei Medical Technology had a
professional internationalization team to develop a plan to establish a clear and standardized enterprise file management template
(DIA eTMF RM V3.1, ICH-GCP required files, 2020 GCP) to ensure a clear structure of file management at home and abroad, complete
and compliant files, and easily cope with audits, which also facilitates the company’s subsequent internationalization projects.
“Taimei’s CTMS and eTMF products are highly professional and fit the sponsor’s needs for unified management of clinical trial studies and files. They regulate the operations of multiple CROs using SOPs, retain data to help statistical analysis and registration, and improve management efficiency and effectiveness. The project manager and business consultant, Tingting Yao, actively participated in the whole project, wrote SOPs and file templates, and assisted in process importing and dissemination, and made great contributions to the management improvement of Lepu Biopharma. ”
-Mao Lei, Senior IT Director, Lepu Biopharma
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