PharmaLegacy Laboratories is a leading Shanghai-based CRO providing specialty preclinical services for a worldwide clientele. They required a FDA 21 CFR Part 11 compliant solution for the capture, real time access and reporting of pharmacology data and implemented E-WorkBook in 2008.
E-WorkBook is the world’s fastest-growing R&D data management solution, and is the dominant biology-focused workflow application in pharmaceuticals and life sciences. Implementing E-WorkBook instantly provided PharmaLegacy with the same quality of data management and collaboration control capability as many of its largest customers, which are international pharmaceutical and biotech companies.
Randomization methods can allocate subjects to group based on baseline measures, such as bodyweight
Business problem, plan for deployment and security
A key capability for any contract research organization (CRO) is the rapid and complete exchange of R&D data with its customers. This is a bottleneck for many contract research and manufacturing organizations and an area where those with distinction can demonstrate a clear competitive advantage.
PharmaLegacy invested in E-WorkBook to ensure that all processes and research methods were fully compliant, giving its clients assurance of quality results and to provide preclinical study data at a faster pace and higher efficiency.
“We originally chose E-WorkBook as it provides the highest level of intellectual property protection and regulatory compliance,” said Mei-Shu Shih, CSO of PharmaLegacy. “We place utmost importance on the security and quality of our data. E-WorkBook has enabled us to implement full audit trails for each item of data. Every time an experiment is altered or additional information is added, we have full confidence that this is tracked and logged.”
E-WorkBook enables PharmaLegacy to collaborate on research across its global sites and with customers, while ensuring that any new discoveries are protected with industry-leading levels of security.
E-WorkBook was the first Electronic Laboratory Notebook (ELN) to be certified compliant with SAFE-BioPharma, the pharmaceutical industry’s standards body on digital authentication.
Reducing report delivery from 10 days to a single day
E-WorkBook provides unparalleled integration and instant reporting of high context R&D data, even in highly regulated environments. It has enabled PharmaLegacy to dramatically improve the production of validated regulatory reports for customers from 10 days to a single day.
“We are very pleased that E-WorkBook has given us such fantastic return on investment, particularly through reducing our time from discovery to validated report,” said Shih. “The solution has enabled us to spend more time on research and capture our results with unparalleled security, more easily communicate across departments and accelerate research into the development and effectiveness of new therapies.”
Competitive advantage to CROs and clients
In an increasingly competitive marketplace, the need for CROs to differentiate themselves with their multinational clients has never been greater. PharmaLegacy can demonstrate that E-WorkBook has enabled their enterprise to be highly streamlined and, through straightforward electronic organization and management of data, that their scientists are able to spend more time on their customer’s research and less time on administrative tasks.
“With IDBS we can capture all our experimental data and context in real time. This makes research faster, easier and more convenient for our scientists compared to using paper records,” said Shih. “These advantages only accrue through full electronic capture, analysis and reporting, and as a result our organization can deliver faster turnaround times with cost savings to our clients.”
PharmaLegacy’s experience and expertise in the preclinical domain is complemented through E-WorkBook. The application enables employees to collaborate on projects with the assurance that their results are effectively monitored and versioned, and drives efficiency through streamlined, best practice workflows.
Experimental results can be automatically captured over time in the
E-WorkBook environment, reducing transcription errors
User satisfaction and future goals
The successful use of E-WorkBook across PharmaLegacy’s pharmacology department has resulted in interest from their DMPK group to implement the application.
“Results since deployment demonstrates the benefit and necessity of choosing effective data management solutions for preclinical research,” said Shih. “E-WorkBook reduces costs, delivers excellent return on investment and accelerates the pace of outsourced drug development."