Jeevan Scientific Technology Limited

“a symbol of quality and diverse solutions”

Hyderabad- India

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Established as global management

consulting, technology services

and outsourcing company

Started medical writing division

Expanded to a “full service”

Clinical Research Organization

1999

2011

2014

Jeevan: Timeline

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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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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.

Jeevan Quality Policy

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Our Commitment

To maintain global quality standards

To add value to clients’ products

To meet with clients’ needs throughProfessional teamwork Efficient communication Timely delivery

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Jeevan Services

Clinical Research Services

Clinical Operations

Bioanalytical

Medical Writing

Pharmacovigil-ance

Biostatistics

Project Management

Quality Assurance

Regulatory Affairs

Clinical Data Management

Education &Staffing Services

Medical - Education

HR Services

Corporate Training

Certification Programs

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

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Bioanalytical Services

Bioanalytical services

MD/MV

Clinical

ELISA

Preclinical

Tech transfer

BA/BE

Phase I to IV

CU

STO

MIZ

ED

S

ER

VIC

ES

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

Bioanalytical: Facilities & Instruments

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.

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Clinical Operations - Services

Clinical Operations

Phase II - IV

BA/BE

Clinical Site Management

PMS & OS

Patients

Healthy Subjects

CU

STO

MIZ

ED

S

ER

VIC

ES

Project Management

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.

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CDM Services

CDM Services

Database Design

CRF Design

Data Handling and Cleaning

Coding as per MedDRA

Data Collection

Database Lock

QA and QC

AE & SAE Reconciliation

Database Validation

Data Mapping

Archival

CU

STO

MIZ

ED

S

ER

VIC

ES

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CRF/e-CRF designing

Data management Plan

Database design and Set-up

Import/Export set up

Dictionary set up (MedDRA)

CRF tracking setup

Double data entry and Verification

Data loading

Data review and query Management

SAE reconciliation

Clinical Data Coding

QC and database audits

Adverse Events

Evaluation of medical & scientific consistence of data.

Periodic review for protocol adherence, data recorded and regulatory file maintenance.

Interim data base closure

QA/QC

Database Lock

Analysis and report

Study Set Up

Study Conduct

Review Study Close Out

CDM Service Overview

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.

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Biostatistics and Statistical Programming Services

Services

Sample Size Calculation

Study Design

PK/PD analysis

Statistical Report

SAP Development

Support for regulatory and

advisory meetings

SAP Program & Interim

Analysis

Scientific Inputs in Protocols

CU

STO

MIZ

ED

S

ER

VIC

ES

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Summarization of

Study objectives

Study subjects

finalization

Determination of

sample size rational

and power

Description of

statistical

methodology Create

and finalize

programming process

Finalize all planned

tables, listings and

Graphs

Creation of

integrated

databases

Creation of tables,

listings and graphs

Exploratory analysis

Summary of

methodologies and

results

Programming

based on SAP or

written

specifications.

Independent

validation of

project specific

programming

QA/QC validation

of output results

Prepare

integrated

Clinical/statistical

report

Study Set Up

Study Conduct

Review Study Close Out

Overview

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.

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Medical Writing Services

Medical Writing

Clinical

Pre Clinical

Medical Education

Marketing

Regulatory Submission

CU

STO

MIZ

ED

S

ER

VIC

ES

Scientific

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26 24 25

2

32

2

95

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10 82

12

2 1 1

42 2

8

5

1

65 2

3

Projects completed Projects in progress

Medical Writing: Jeevan’s Accomplishments Since 2012: Metrics by Project Type

~170 completed projects and 35 ongoing!!

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.

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Safety/Medical monitoring

Medical review of data listings

Review of medical coding data

Literature evaluations

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

Pharmacovigi-lance

Pharmacovigilance Services

CU

STO

MIZ

ED

S

ER

VIC

ES

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.

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Regulatory Affairs Services

Regulatory affairs

Application for EC opinion

Assistance in IEC/IRB application process

Compilation of documents

Preparation and Management of CT

applications

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.

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Quality Assurance Services

Quality Assurance

Investigator Site Qualification Audits

CRO Qualification Audits

Study Audits

Preparing investigator sites for inspection

Investigator site

CRO

For Cause Audits

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.

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Project Management Services

Project Management

Project Planning and Execution

Resource allocation

Site identification and assessment

Contract Management

Vendor Management

Development of monitoring strategy

CRA training

Monitoring reports review and submission

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

Business contact: Mr. Vasudev Sureddy Phone: +91-76590 11000 e-mail: vasudev.sureddy@jeevanscientific.com

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.

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