Clinical Research Services - Jeevan ... - Jeevan Scientific Scientific Brochure.pdf · Clinical...
Transcript of Clinical Research Services - Jeevan ... - Jeevan Scientific Scientific Brochure.pdf · Clinical...
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
Global Operations
+91-40-30912999
Plot No. 1&2, Sai Krupa Enclave
Near Lanco Hills, Golconda (PO)
Hyderabad 500 008, INDIA.