Jeevan ScientificTechnology Limited

a symbol of quality and diverse solutions

Clinical Research Services

JEEVAN SCIENTIFIC TECHNOLOGY LIMITED

Jeevan Scientific is an Independent Contract Research Organization, established in the year 1999, located

in Hyderabad, India. In 2015, Jeevan incorporated its US arm.

Jeevan has been built with state of the art facilities and expert resources to provide broad range of clinical

research services for healthcare/pharmaceutical industries across the globe.

Jeevan’s service portfolio hosts a spectrum of services that enables us to provide an integrated solution

for the management of clinical development right from its inception to completion and post-marketing.

Jeevan is a perfect blend of technology, innovation and expertise, which enables us to provide reliable,

cost-effective and technology driven services and solutions to clients.

MISSION, VISION & VALUES

To realize our Vision of being a clinical research organization (CRO) with global distinction, we ensure that

our services adhere to the highest standards, which are at par with global quality standards, and set new

benchmarks.

Jeevan’s quality policy is to achieve sustained and profitable growth by providing services, which

consistently satisfy or exceed the needs and expectations of clients.

Jeevan has continued to grow and evolve by attracting superior talent, developing valuable resources

and investing in state-of-the-art facilities to deliver clients the best .

Our commitment to quality, and customer-focused approach bundled with outstanding expertise

distinguishes us from others.

Clinical Operations Ÿ BA/BE (Healthy/Patient)

Ÿ Phase II to IV

Ÿ Trial Management

Ÿ Trial Supply Management

Bioanalytical

Regulatory Affairs

Medical Writing

Ÿ Subject sample analysis

Ÿ MD & MV

Ÿ Pre-clinical samples

Ÿ Dossier Management

Ÿ Strategy and Intelligence

Ÿ Labeling and Publishing

Ÿ Business & Outsourcing

Ÿ Commercial Writing

Ÿ Scientific Writing

Ÿ Medical Writing and Technical

Writing

CDMŸ Data management

Ÿ Biostatistics and statistical

programming services

Pharmacovigilance

Project Management

Quality Assurance

Ÿ Case processing

Ÿ Aggregate reports

Ÿ Signal detection and Risk

management plans

Ÿ Clinical site management

Ÿ Site identification and Vendor

management

Ÿ Monitoring reports review and

submission

Ÿ Investigator, CRO site and

qualification audits

Ÿ Preparing investigator sites for

inspections

Ÿ Site monitoring services

Ÿ For cause audits

SERVICE PORTFOLIO

CLINICAL OPERATIONS

Ø Dedicated Clinical facility with floor space of 20,000sq.ft

Ø 4 independent access controlled clinic units with total of 132 beds

Ø 2 ICU units each consist of 4 beds with all emergency equipment's

Ø Biometric based software for volunteer registration

Ø In-house Clinical diagnostic laboratory

Ø Access controlled pharmacy with special provision to store controlled substances

Ø Qualified medical staff (DM, MDs, general physicians and Paramedical team)

Ø Temperature monitoring devices across the facility

ServicesØ Healthy subject and Patient based BE studies

Ø Mixed gender studies

Ø Post menopausal studies

Ø PK/PD end point studies

Ø Food and Drug interaction studies

Ø Single and double blind studies

Ø Studies on controlled drug substances

Ø Single and Multiple dose studies (fast and fed)

Ø Dose escalation studies

Ø Execution of studies on various range of formulations like

Orals (solid oral and liquid oral), injectable and inhalations

Infrastructure

Ø Rich pool of clinical investigators across the country

Ø Experience in wide range of therapeutic areas

Ø Trial and Site management/monitoring by qualified and experienced CRAs

Ø Dedicated Project Management for tracking of project and timely monitoring of data to help

sponsor remain consistently aware of project status

Patient based studies

BIOANALYTICAL RESEARCH

ServicesØ Method Development, method validation (MD and MV)

and analysis of samples for clinical trials

– Pharmacokinetic studies

– BA/BE studies

– Drug interaction studies

– Early phase studies

Ø Estimation of drugs and metabolites in biological matrix

(using extraction techniques: SPE, LLE) of sample from

pre-clinical and clinical studies

Ø MD/MV of highly sensitive analysis

Ø Dedicated Bio-analytical facility with floor space of 5000 Sq.Ft

Ø Having provision to accommodate up to 12 LC-MS/MS

Ø High end equipments (LC-MS/MS) with validated software

Ø Provisions for handling of both normal and light sensitive molecules

Ø New method development and validation is continuous process

Ø Access controlled sample storage area with 24X7 sample receipt and monitoring

Ø Method development and validation by Qualified and experienced team

Ø Online temperature monitoring through Eurotherm

Infrastructure

DATA MANAGEMENT, PHARMACOKINETIC & STATISTICAL ANALYSIS)

Ø Customized Data Management services

– Assistance in study design

– CRF/e-CRF design

– Tables, Listings and graphs

– Preparation of Randomization schedules

– Development of Statistical analysis plan (SAP)

Ø PK analysis and data simulation by using WinNonlin

Ø Statical analysis by using validated tools like SAS®

Ø Development of report in e-CTD format

Ø EDC (Electronic Data Capture)

Ø Independent Quality Assurance Department & robust Quality Management System.

Ø All projects performed at Jeevan are audited by our quality assurance department for compliance to

USFDA, EMEA and other applicable regulations by following ICH-GCP guidelines and compliance.

Ø Experience in handling several regulatory audits like UKMHRA, USFDA, Health Canada, WHO, ANVISA

and MOH-Turkey

Ø All projects are handled by technically qualified and experienced project management team

Ø Our Project managers have robust knowledge on global project management skills and experience in

handling global projects

Ø Representing the client in inside the organization by providing best support.

Ø Our experienced PM will predict the possible risks of the project and ready with the mitigation

strategies beforehand.

QUALITY ASSURANCE AT JEEVAN

Services

PROJECT MANAGEMENT

KEY DIFFRENTIATION

Independent CRO

Effective study management

Our Experienced project managers ensure

consistent global procedures, rigorous

oversight and easy access to integrated data.

Public limited company

Enhance your capabilities

without adding fixed costs

Experienced staff, global state-of-the-art

facilities and clinical site relationships

facilitate studies across a range of

therapeutic areas, geography, size and

complexity

Variablize costs and share risk

Innovative partnering and alliance models

reduce infrastructure costs and enhance

strategic capacity planning.

Enhanced site performance

Jeevan actively manages each site,

ensuring that all protocols are

followed and all goals are reached.

Experienced global project managers

Pro-actively prepare solutions and take

ownership of project and its

deliverables

Move smarter to patient studies

Site relationships and multi-center study

management expertise, coupled with

therapeutic knowledge, help you

successfully deliver early patient studies

Hands on experience

handling various

projects in diverse

therapeutic areas

Team has experience

in Execution of more

than 1500 clinical

research projects

Offering varied

range of clinical

research

services across

Phase I to IV

Advantages with Jeevan

Fully integrated

scientific

expertise team

Leadership team

at Jeevan has 125

years of Cumulative

experience

+1 848-219-9146

US Ofce13111 N Central Expy, Suite 8031

Dallas TX 75243

www.jeevanscientific.com

bd@jeevanscientific.com

Global Operations

+91-40-30912999

Plot No. 1&2, Sai Krupa Enclave

Near Lanco Hills, Golconda (PO)

Hyderabad 500 008, INDIA.