- Chapter 1: Laboratory informatics for the bioanalytical laboratory
- Chapter 2: Laboratory information management systems (LIMS) for bioanalysis
- Chapter 3: Development of an integrated informatics solution for advanced bioanalytical business analytics
- Chapter 4: Electronic notebooks in the bioanalytical lab: a perspective on determining return on investment (ROI)
- Chapter 5: Electronic notebooks: the paperless laboratory
- Chapter 6: Computerized system validation
- Chapter 7: Importance and application of electronic standards in bioanalysis
- Chapter 8: Automation tools
- Chapter 9: The future of big data in regulated bioanalysis: clouds, trends and transparency
- Appendix: Pertinent Regulations and Guidances in Electronic Data Use
Jahanara (Jan) Miotto
President, Metrendalytics LLC
Plaza Square, Suite 2018,
New Brunswick, N.J. 08901
Tel: +1 914 760 4644
Follow me on Twitter @nyswiss1
About the Author
Jahanara (known as Jan) Miotto has over 25 years of experience within pharmaceutical R&D spanning both nonclinical and clinical disciplines. She conceptualized and led the development of a variety of cost-efficient and scalable cloud-based applications for the centralization, aggregation and standardization of data for real-time analytics. The use of business analytics created significant efficiencies across project planning and execution, enabling real-time data access to actively manage operational performance, mitigate risk, and shape smarter business decisions.
Jan has recently has established Metrendalytics Consulting (NJ, USA), focused on helping companies develop highly customized and flexible business intelligence solutions. Developed platforms enable organizations to extract data from disparate sources and diverse data types to provide ready-to-analyze aggregated data for critical business applications, paper-lite operations and advanced business analytics.
Jan has a Masters degree in Analytical Chemistry and Mathematics from City University of New York (NY, USA). She is co-author on over 20 scientific papers and the recipient of two global patents.
Development of an integrated informatics solution for advanced bioanalytical business analytics
Creating business value from your data
In today’s drug development environment, timely access to information regarding project activities, status and financials will help you facilitate resource projections and streamline your operations. Establishing a centralized informatics platform will uniquely position the bioanalytical lab in the achievement of near real-time information, greater control, improved communication and reduced operational costs.
Companies are now recognizing that in order for them to be competitive they need to take advantage of their data, to leverage it data and turn it into insight. Companies cannot rely on spreadsheets or static reports that are barely useable. Cost–effective technologies are readily available today to make sense of all this data and accelerate the pace of analytics.
The bioanalytical challenge
Pharmaceutical companies are facing increasing challenges for enhancing productivity while reducing costs. Given today’s time pressures and the high cost of discovery and development in biopharmaceutical research, it is more important than ever that supporting services, such as bioanalysis, are optimized for speed and success . The bioanalytical laboratory is charged with rapidly developing methodologies to support pre-clinical and clinical development. As development moves from nonclinical to clinical investigations, the bioanalytical support required also undergoes a transition. In early stages, the focus is on science, creating and refining analysis methods that will accurately and efficiently assess the drug level in a variety of species and biological matrices. As the drug moves to later stages of development (Phases II–IV), the challenges of sample transport and handling from complex, multi-site, often multi-country trials, along with substantial data management needs, add a requirement for logistical excellence in addition to scientific capability.