Transcript Document

Jeevan Scientific Technology Limited
“a symbol of quality and diverse solutions”
Hyderabad- India
Jeevan: Timeline
Expanded to a “full
service” Clinical
Research
Organization
2014
Started medical
writing division
2011
Established as global
management
consulting, technology
services and
outsourcing company
1999
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Our Mission, Vision and Values
Mission
• At Jeevan, our mission is to deliver value added, reliable
and cost-effective services to our customers, through our
core values.
Vision
• To be an integrated CRO with global distinction, aiming for
long-term partnership with our customers based on shared
beliefs and goals for synergetic growth.
Values
• Quality, Customer service, Integrity, Teamwork,
Commitment, Accountability, Innovation, Personal Growth,
Initiative, On-time delivery.
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Jeevan Quality Policy
 To ensure that our services adhere to the highest standards which are at par with global
quality standards and even setting new benchmarks.
 To achieve sustained and profitable growth by providing services, which consistently
satisfy the needs and expectations of customers.
 Quality is not just another goal, but is a basic strategy for survival and growth, hence we
promote a quality-in-all-we-do philosophy with a total company effort and
commitment to continuous improvement.
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Our Commitment
To meet with clients’ needs through
Professional teamwork
Efficient communication
Timely delivery
To add value to clients’ products
To maintain global quality standards
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Jeevan Services
Bioanalytical
Clinical
Operations
Clinical
Research
Services
Clinical Data
Management
Medical Education
Biostatistics
HR Services
Medical Writing
Corporate
Training
Pharmacovigilance
Certification
Programs
Regulatory
Affairs
Quality
Assurance
Project
Management
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Education
&Staffing
Services
Bioanalytical Services
At Jeevan, we have a state of the art facility
equipped with advanced analytical
instrumentation and an efficient workforce.
We follow applicable GLP principles/regulations
and SOPs. We work closely with our clients to
identify their requirements and meet their
expectations including cost and time constraints.
Bioanalytical Services
Clinical
MD/MV
Bioanalytical
services
Tech transfer
Preclinical
ELISA
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Phase
I to IV
CUSTOMIZED
SERVICES
BA/BE
Bioanalytical: Facilities & Instruments
State-of-the-art facilities:
LC-MS/MS Systems
HPLCs
Deep freezers -200C and -800C
Solid phase and Liquid-liquid extractor
Temperature monitoring systems
ELISA
Clinical Operations
Jeevan has the expertise to manage
Bioavailability and Bioequivalence
(involving healthy volunteers & patients)
and Phase II to IV studies with qualified
and trained workforce.
We are committed to ensure patient rights,
safety and data integrity.
Clinical Operations - Services
BA/BE
Phase II - IV
Clinical
Operations
PMS & OS
Clinical Site
Management
Project
Management
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Healthy
Subjects
CUSTOMIZED
SERVICES
Patients
Clinical Operations - Capabilities

Protocol writing

Site identification and assessment

Facilitate IRB/IEC application process

Regulatory application process

Project management

Site initiation

Site training and support

Site monitoring

Investigational product accountability

100% source documentation verification and data query clarification

PK and statistics

Report writing

Site close-out
Clinical Data Management Services (CDM)
Jeevan provides data management
services by strict adherence to established
operating procedures and apply quality
standards and processes to complete
large and complex clinical programs.
Our systems are in compliance with
applicable regulations / guidelines for
managing data.
CDM Services
CRF Design
Database Design
Data Collection
CDM Services
Data Handling
and Cleaning
Coding as per
MedDRA
AE & SAE
Reconciliation
QA and QC
Database Lock
Data Mapping
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Archival
CUSTOMIZED
SERVICES
Database
Validation
CDM Service Overview
Study Set Up
Study Conduct
Review
Study Close Out
CRF/e-CRF designing
Double data entry and
Verification
QC and database
audits
Interim data base
closure
Data management
Plan
Data loading
Adverse Events
QA/QC
Database design and
Set-up
Data review and query
Management
Evaluation of medical
& scientific consistence
of data.
Import/Export set up
SAE reconciliation
Dictionary set up
(MedDRA)
Clinical Data Coding
CRF tracking setup
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Periodic review for
protocol adherence,
data recorded and
regulatory file
maintenance.
Database Lock
Analysis and
report
Biostatistics and Statistical Programming Services
Jeevan clinical biostatistics services are
comprehensive and can be tailored to
meet the needs of client requirement.
Jeevan services include pre-analysis,
analysis and post-analysis.
Biostatistics and Statistical Programming Services
Study Design
Scientific Inputs in
Protocols
Services
SAP Development
PK/PD analysis
Statistical Report
SAP Program &
Interim Analysis
Support for
regulatory and
advisory meetings
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CUSTOMIZED
SERVICES
Sample Size
Calculation
Overview
Study Set Up
Study Conduct
Review
Study Close Out
Summarization of Study
Creation of integrated
 Programming based
Prepare integrated
objectives
databases
on SAP or written
Clinical/statistical
Study subjects finalization
Creation of tables,
specifications.
report
Determination of sample
listings and graphs
 Independent
size rational and power
Exploratory analysis
validation of project
Description of statistical
Summary of
specific programming
methodology Create and
methodologies and results
 QA/QC validation of
finalize programming
process
Finalize all planned tables,
listings and Graphs
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output results
Medical Writing Services
Jeevan medical writing services provide a
range of high-quality documents for all
phases of product life cycle, from pre-clinical
development through post marketing.
Medical Writing Services
Clinical
Medical
Writing
Regulatory
Submission
Marketing
Medical
Education
Scientific
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CUSTOMIZED
SERVICES
Pre Clinical
Medical Writing:
Jeevan’s Accomplishments Since 2012: Metrics by Project Type
Projects completed
Projects in progress
8
4
2
2
32
~170
completed
projects and
35 ongoing!!
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2
25
5
24
5
9
2
21
2
6
1
5
7
2
10
12
8
2
2
1
3
1
Pharmacovigilance Services
Jeevan offers comprehensive
pharmacovigilance and safety monitoring
services from early development support
through post-approval initiatives.
Jeevan have experienced and skilled medical
professionals with first-hand knowledge of
regulatory requirements.
Pharmacovigilance Services
Safety/Medical monitoring
Medical review of data listings
Literature evaluations
Pharmacovigi
-lance
Preparation of common technical document
module II
Individual case safety reports
Expedited reporting of serious adverse events
AEs and SAEs logging, tracking, coding, case
processing &distribution
Periodic safety updates
Safety analysis and benefit-risk evaluation
Clinical safety reports
Risk evaluation and mitigation strategies
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CUSTOMIZED
SERVICES
Review of medical coding data
Regulatory Affairs Services
Jeevan provide expert services for the
management of local regulatory issues with
the regulatory authorities and fulfill client
expectations in a realistic and transparent
manner.
Jeevan have in depth knowledge of the
requirements of US FDA, EMEA, DCGI and
other regulatory authorities, related to
clinical development.
Regulatory Affairs Services
Application for EC opinion
Assistance in IEC/IRB
application process
Regulatory
affairs
Compilation of documents
Preparation and
Management of CT
applications
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Quality Assurance Services
Jeevan offer the Quality Assurance services
in GCP and GLP domains in-line with
applicable GxP regulations.
Quality assurance auditors are
knowledgeable about local, national and
international regulations, standards and
guidelines.
Quality Assurance Services
Investigator Site
Qualification Audits
CRO Qualification Audits
Quality
Assurance
Investigator
site
Study Audits
CRO
Preparing investigator
sites for inspection
For Cause Audits
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Project Management Services
Jeevan provides end to end management of
various phases of clinical research projects.
Project manager serves as a primary
resource and point of communication for
the client and project team.
Jeevan’s Project Manager provides
leadership and direction to the team,
including specification for time, quality and
cost of deliverables.
Project Management Services
Project Planning and
Execution
Resource allocation
Site identification and
assessment
Contract Management
Project
Management
Vendor Management
Development of
monitoring strategy
Monitoring reports review
and submission
CRA training
Proactive risk
management
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Why Jeevan
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In a Nutshell
Jeevan provides flexibility to meet
client expectations and goals by
providing solutions which are
reliable and cost-effective
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Contact Us
Business contact:
Mr. Vasudev Sureddy
Phone: +91-76590 11000
e-mail: [email protected]
Address:
Jeevan Scientific Technology Limited
Plot No. 1&2, Survey No. 202
Sai Krupa Enclave
Manikonda Jagir, Near Lanco Hills
Hyderabad - 500 089
Telangana., India.
Thank You