UNIT-V

COMPUTER AS DATA
ANALYSISIN PRECLINICAL
DEVELOPMENT
Points to be covered in this topic
OINTRODUCTION

OCHROMATOGRAPHIC DATA ANALYSIS

>0LABORATORY INFORMATION

MANAGEMENT SYSTEM

’ 0TEXT INFORMATION MANAGEMENT

SYSTEM
 COMPUTERAS DATA
ANALYSIS IN PRECLINICAL
DEVELOPMENT
OINTRODUCTION
Computers play a significant role in
preclinical development. They help
alot in data analysis.
Preclinical development refers to
development of adequate data,
facts and figures to ensure that a
particular drug is safe for human
use.

Before any drug istested on humans, a lot of experimentsare conducted on

animals to ensure that the treatment goes well as per expectation and
outcome is generated. Only then a drug is declared safe for human testing.
All the data related to a drug, use, safety, dosage, outcome, interactions,
pharmacological effect, preclinical testing methods, FDA approval, over
dosage etc. are considered well before the launch of any product in the
market.

This crucial information is entered

and stored in computers that can be

further analyzed as and when
requíred by scientists, pharmacists,
physicians and other healthcare
professionals.
 Role of computers in preclinical development
Act as storehouse of drug information
Aids in study of toxicology and risk assessment
Helps to develop predictive models for better decisions
Makes pharmaceutical development more efficient
Ensures collection and management of clinical data
Aids in better medical decision making

Improves quality of healthcare management

OCHROMATOGRAPHIC DATA ANALYSIS (CDS)
CDS refers to software that simplifies entire
workflow process and saves lot of time and
energy.
It gives better and faster results. This software is used
tocollect and analyze chromatographicresults i.e.
technique used to separate mixtures in a laboratory. Chromatography
Thus,CDS is related to effective workflow within a laboratory.
CDS can also be referred to as a workstation that controls all the

instruments present in a laboratory.

It represents an integrated system with all the data saved in a central
server.

CDS PRODUCTS
Some well known CDS products are
Chromeleon 7.2 CDSSoftware - It is
CHROMELEON Z2
Spy hlgyt
used to simplify lab workflow with
a unified control for effective data
management.
 Laboratory Information Management Systems - Manages all workflow
within a - laboratory. It reduces implementation, training and validation
costs of an organization.
Scientific Data Management System - Securely shares data across
multiple users in an organization.
Integrated Solutions - Provides most effective lab data by integrating
instruments and software.

The importance of CDS can be judged from the fact that high-performance
liquid chromatography (HPLC) and gas chromatography (GC) play an
important role in pharmaceutical analysis. Research and development in
Pharmaceutical companies is almost impossible without these two types of
chromatography.
OLABORATORY INFORMATION MANAGEMENT SYSTEM
(LIMS)
Laboratory Information Management System refers to software based
data management system that supports all modern laboratory
operations.
LIMS form an important part of data management systems used in
preclinicaldevelopment.
LIMS were designed to automate major parts of development like sample
tracking, sample distribution, work assignment, result capturing, data
processing, data review, report generation, and datasharing.
Thus, LIMS has fastened the process of management in preclinical
development.
 Sample Quality
Management Assurance

Worklow Reporting
Management /Certificates

Stability
Studies JDocumentation
Electronic LIMS Instrument
Lab Connections
Notebocok IPlanning

Sample Inventory
Tracking Management
Quotation Lab Excecution
&Invoicing System

º APPLICATIONS OF LIMS
Sample Management - The primary function of LIMS is management of
samples received in the laboratory, Barcodes are fixed to the sample
containers in order to distinguish them from other samples. A
complete record is maintained about the sample and its location in the lab
ie. row, column,box, freezer time, report generation time etc.
Instrument and Application Integration - An effective LIMS requires
proper integration of instruments and applications.This ensures accurate
and effective result generation.
Electronic Data Exchange - Great attention is paid tokeep acheck on the
data entered and output generated in an instrument. The successful
transfer of data from the lab tothe appropriate user (physician, doctor,
lab technician etc.) is an important task to be undertaken by LIMS.
Report Generation- LIMS is also responsible for effective report
generation inthe specified formats and scheduled timeperiods.
Inventory Management -It measures and records inventory of all vital
supplies within a laboratory.
 BENEFITS OF LIMS

Fast reports
Reduction in paper work
V Improved efficiency
Improved data quality
Reduced errors
Avoids duplicacy
Simple formulas for calculation
Better integration with other departments
TEXT INFORMATION MANAGEMENT SYSTEM (TIMS)
Text Information Management System refers to collection and
management of text information from one or more sources that can be
shared with different users at the right time and right place.
The information is entered, processed and
stored in the computer and later on, can be
used as per requirement.
The information can be stored in any format
like images, video sequences, audio
messages, text message, numerical

information etc.
For any successful organization,it is mandatory to be structured in a way
that it can manage its information through various sources and
formats and then deliver the same through varied channels like cell
phones and web interfaces.
Thus, the capability of an organization to capture, manage, preserve,
store and deliver the right information to the right people at the right
time is known as Text Information Management System.
 It is also an organization's responsibility to store the data in a secured
way and at the same time ensure proper safety and security of
customer's personal information.
It is an utmost responsibility of an organization to keep the information
confidentialand secure and release it only to the reliable sources.
TIMS is a type of database management system which supports an access
methodbased on both select and search queries.
TIMS is mainly used by scientists as a report template to facilitate report
writing.
Once the draft is ready, they can send electroniclink of the document
for review.

Necessary changes and anmendments are done in the report and then final
auditingisdone to convert the existing templateinto final report.
These reports can be further assessed by different users. Thus, TIMS saves
a lot of time and energy.

Quality ManagementSystem

Compliance Management Environmental Management

System QMS
System
CMS EMS

Information Security
(SMS
(IMS SMS Safety Management
Management System System

FSMS EnMS

Food Safety Management Energy Management

System System
 BENEFITS OFTIMS
Saves time and energy
Faster method of report generation
Ensures accuracy

Improves efficiency in managing critical data

Reduced paper work
Strict security
Smooth and easy work flow
TIMS is a one step towards encouraging the process of writing, reviewing,
auditing. approving and publishing the pharmaceutical text reports in
one go. However, changes and up-gradations are still required to make
thisprocess more effective.