1. Jeevan Scientific Technology Limited
“a symbol of quality and diverse solutions”
Hyderabad- India

2. Expanded to a “full service” Clinical Research Organization
Jeevan: Timeline
Expanded to a “full service” Clinical Research Organization
Started medical writing division
2014
Established as global management consulting, technology services and outsourcing company
2011
1999

3. Our Mission, Vision and Values
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.

4. 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.
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 even setting new benchmarks. Jeevan quality policy is to achieve sustained and profitable growth by providing services, which consistently satisfy the needs and expectations of customers.
We recognize that 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.

5. Our Commitment To maintain global quality standards
To meet with clients’ needs through
Professional teamwork
Efficient communication
Timely delivery
To add value to clients’ products
To maintain global quality standards

6. Jeevan Services Clinical Research Services
Bioanalytical
Clinical Operations
Medical - Education
Clinical Data Management
Clinical Research Services
HR Services
Biostatistics
Education &Staffing Services
Corporate Training
Medical Writing
Certification Programs
Pharmacovigil-ance
Regulatory Affairs
Quality Assurance
Project Management

7. 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.

8. Bioanalytical Services
BA/BE
Clinical
Phase I to IV
MD/MV
CUSTOMIZED SERVICES
Bioanalytical services
Tech transfer
Preclinical
ELISA

9. 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

10. We are committed to ensure patient rights, safety and data integrity.
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.

11. Clinical Operations - Services
Patients
BA/BE
Healthy Subjects
Phase II - IV
Clinical Operations
CUSTOMIZED SERVICES
PMS & OS
Clinical Site Management
Project Management

12. 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

13. 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.

14. Data Handling and Cleaning AE & SAE Reconciliation
CDM Services
CRF Design
Database Design
Database Validation
Data Collection
CDM Services
CUSTOMIZED SERVICES
Data Handling and Cleaning
Coding as per MedDRA
AE & SAE Reconciliation
QA and QC
Database Lock
Data Mapping
Archival

15. CDM Service Overview Study Set Up Study Conduct Review Study Close Out
QC and database audits
Adverse Events
Evaluation of medical & scientific consistence of data.
Periodic review for protocol adherence, data recorded and regulatory file maintenance.
Double data entry and Verification
Data loading
Data review and query Management
SAE reconciliation
Clinical Data Coding
Interim data base closure
QA/QC
Database Lock
Analysis and report
CRF/e-CRF designing
Data management Plan
Database design and Set-up
Import/Export set up
Dictionary set up (MedDRA)
CRF tracking setup

16. Jeevan services include pre-analysis, analysis and post-analysis.
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.

17. Biostatistics and Statistical Programming Services
Study Design
Sample Size Calculation
Scientific Inputs in Protocols
CUSTOMIZED SERVICES
Services
SAP Development
PK/PD analysis
Statistical Report
SAP Program & Interim Analysis
Support for regulatory and advisory meetings

18. Overview Study Set Up Study Conduct Review Study Close Out
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
Programming based on SAP or written specifications.
Independent validation of project specific programming
QA/QC validation of output results
Creation of integrated databases
Creation of tables, listings and graphs
Exploratory analysis Summary of methodologies and results
Prepare integrated Clinical/statistical report

19. 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.

20. Medical Writing Services
Pre Clinical
Clinical
CUSTOMIZED SERVICES
Regulatory Submission
Medical Writing
Marketing
Medical Education
Scientific

21. ~170 completed projects and 35 ongoing!!
Medical Writing: Jeevan’s Accomplishments Since 2012: Metrics by Project Type
~170 completed projects and 35 ongoing!!

22. 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.

23. Pharmacovigilance Services
Safety/Medical monitoring
Medical review of data listings
Review of medical coding data
Literature evaluations
CUSTOMIZED SERVICES
Preparation of common technical document module II
Pharmacovigi-lance
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

24. 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.

25. Regulatory Affairs Services
Application for EC opinion
Assistance in IEC/IRB application process
Regulatory affairs
Compilation of documents
Preparation and Management of CT applications

26. 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.

27. Quality Assurance Services
Investigator Site Qualification Audits
CRO Qualification Audits
Investigator site
Quality Assurance
Study Audits
CRO
Preparing investigator sites for inspection
For Cause Audits

28. 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.

29. 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

30. Why Jeevan

31. In a Nutshell
Jeevan provides flexibility to meet client expectations and goals by providing solutions which are reliable and cost-effective

32. Contact Us Business contact: Address: Mr. Vasudev Sureddy
Phone:
Address:
Jeevan Scientific Technology Limited
Plot No. 1&2, Survey No Sai Krupa Enclave Manikonda Jagir, Near Lanco Hills Hyderabad Telangana., India.

33. Thank You