Unit V

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UNIT V

COMPUTERS AS DATA ANALYSIS IN PRECLINICAL DEVELOPMENT


DRUG DEVELOPMENT PROCESS
DATA ANALYSIS AND BIG DATA IN HEALTHCARE

• Data analysis is defined as a process of cleaning, transforming, and modeling data to


discover useful information for business decision-making. The purpose of Data
Analysis is to extract useful information from data and taking the decision based upon
the data analysis.
• Big data in healthcare is a term used to describe massive volumes of
information created by the adoption of digital technologies that collect
patients' records and help in managing hospital performance
HEALTHCARE AS A BIG-DATA REPOSITORY

• Healthcare is a multi-dimensional system established with the sole aim for the
prevention, diagnosis, and treatment of health-related issues in human beings
• At all these levels, the health professionals are responsible for different kinds of
information such as patient’s medical history (diagnosis and prescriptions related
data), medical and clinical data (like data from imaging and laboratory
examinations), and other private or personal medical data.
TYPES OF HEALTHCARE DATA

• Administrative Data
Usually, such information is collected from each patient separately based on appointments,
registration in certain programs, and more. Such administrative data may consist of the
frequency and duration of visits.
• Electronic Health Records
Electronic health records (EHRs) contain all information about a person’s medical history.
That also includes their previous illnesses, treatment, and treatment results.
• Clinical Data
There are certain healthcare facilities, such as nursing homes, that are required to provide
standardized healthcare data.
This data is used by various medical institutions to understand how to properly allocate
resources between different institutions.
• Insurance Claims Data
• Patient Surveys
• Medical institutions also conduct surveys of their patients to find out what health care
services they were satisfied with and what services they didn’t like.
INTRODUCTION

• Scientists from different disciplines participate in pharmaceutical development .


• CDS(Chromatographic Data System), LIMS (Laboratory Information Management
System) , TIMS(Text Information Management System) handles the majority of work
data and document management in preclinical activities.
• Laboratory Information Management Systems are widely used
throughout organizations that specialize in R&D
CHROMATOGRAPHY DATA SYSTEM

• Chromatography :- a technique for the separation of a mixture by passing it in


solution or suspension through a medium in which the components move at
different rates.
• A chromatography data system (CDS) is a typical laboratory informatics
solution that facilitates chromatography-based analysis. It controls data from
chromatography instruments, records and processes, and generates
chromatograms and reports.
ELEMENTS OF CDS

Elements of CDS and how to interact with the gas and liquid chromatograph
• Instrument control
• Data acquisition via an analog or digital converter
• Data integration
• Calculate and report results
PROCESS WORKFLOW OD CDS
TYPES OF CDS
• Indicator- Single user and single instrument data acquisition
• Workstation - Single user and single instrument data acquisition and control
• Client server – Multiple user with multiple instrument data acquisition with option for control
• Terminal Server - Multiple user by terminal server farm with multiple instrument data acquisition
with option for control
LABORATORY INFORMATION MANAGEMENT SYSTEM
(LIMS)
• A Laboratory Information Management System (LIMS) is software that allows you to effectively manage
samples and associated data. By using a LIMS, your lab can automate workflows, integrate instruments, and
manage samples and associated information.
• A LIMS is a database system for maintaining records of work or activities carried out in a laboratory with a
date and time stamp. Sample tracking, traceability, data collection, workflow automation, and report
generation are the major needs of any laboratory. A LIMS helps laboratories automate their data entry
processes, manage inventory, streamline their workflows, and assure quality. It reduces time spent on locating
samples and records, entering data, calculating results, and generating reports. Hence, a LIMS not only
increases the efficiency of a laboratory but also the pace of research and analysis, assisting compliance with
quality and regulatory standards at the same time.
WHAT ARE THE CORE COMPONENTS OF LIMS?

• https://thirdwaveanalytics.com/blog/what-does-a-lims-do/
KEY ADVANTAGES OF USING A LIMS
WHAT DOES A LIMS DO FOR LABORATORIES?
• Accessing of samples as soon as they enter a laboratory.
• Tracking samples throughout the sample life-cycle.
• Managing Quality Assurance (QA) and Quality Control (QC) processes and recording associated data.
• Managing tests, test results, and flagging out-of-specification(surprising specifications) results to quickly identify abnormal
observed values.
• Tracking inventory to reorder laboratory supplies and stocks for running tests and/or creating kits for storing samples.
• Generating custom reports or Certificates of Analysis (CoA).
• Automating data transfer by integration with analytical instruments to avoid transcription errors.
• Monitoring the laboratory environment and recording data such as instrument calibration and maintenance, personnel training
and competency records, customer details, non-conforming activities and resolutions to the issues reported by customers.
• Managing documents, such as Standard Operating Procedures (SOPs), tracking their revision history and controlling the access
of documents to prevent unauthorized access.
TIMS

• TIMS is not common as LIMS but TIMS is important for preclinical activities as large no
of text documents and other associated information like image, drawings and photographs
is generated here.
• These documents and information are intellectual property and therefore need protection
and easy access
• Scientists using TIMS in today workflow use Report Template for template writing

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