Anda di halaman 1dari 19

Plot No. 1&2, Sai Krupa Enclave, Near LANCO Hills, Golconda post, Hyderabad - 500 008, India.

+91-40-30912999 | info@jeevanscientific.com | www.jeevanscientific.com

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Timeline
Established as Global Expanded to a full Incorporation of
Management Consulting, service Clinical ENHOPS Solutions Pvt.
Technology Services and Research Organization Ltd, a 100% subsidiary
Outsourcing company of Jeevan Scientific

1999 2014 2015

2011 2015 2015


Started medical writing Facility approved by Incorporation of
division DCGI Jeevans US arm,
ENHOPS Inc.

Jeevan is Independent Clinical Research Organization


Jeevan is a limited company listed in BSE

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Jeevan Scientific

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Advantage with Jeevan Scientific

Fully Offering The technical team has


integrated Leadership team Team has
varied range immense experience in
scientific at Jeevan has 125 experience in
of clinical handling various projects
expertise years of Execution of more
research in diverse therapeutic
team Cumulative than 1500 clinical
services areas for different experience research projects
across Phase I regulatory authorities.
to IV for several
Pharma clients
across the globe

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Services Range

Clinical Research Services


Phase I Phase II Phase III Phase IV
Clinical Study design - Protocol

PK PD Trials
Proof of concept, Safety & Efficacy Trails

Interaction trials (Drug/Drug, Food, Age, Gender etc)

BA/BE Studies

PMS, OS

Clinical trial Monitoring and Management

Data Management, Statistics and Medical Writing

Regulatory Affairs, Drug Safety and Pharmacovigilance

Lead Optimization and Sample analysis

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Services

Clinical Operations Bioanalytical Regulatory Affairs Medical Writing


Dossier Management Commercial Writing
BA/BE (Healthy/Patient) Subject sample analysis Strategy and Intelligence Scientific Writing
Phase II to IV MD & MV Labeling and Publishing Medical Writing and
PMS & OS Tech transfer Business & Outsourcing Technical Writing

CDM Pharmacovigilance Project Management Quality Assurance


Data management Case processing Clinical site management Investigator, CRO site and
Biostatistics and Aggregate reports Site identification and qualification audits
statistical programming Signal detection and Risk Vendor management Preparing investigator
services management plans Monitoring reports sites for inspections
review and submission Site monitoring services
For cause audits

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Clinical Operations

Vast experience in executing clinical projects of different therapeutic areas


Clinical Operations
Rich pool of clinical investigators experienced various phases of clinical projects
BA/BE (Healthy/Patient) including PK/PD.
Phase II to IV
PMS & OS Ability to identify potential clinical sites for Phase I to IV studies in a quick
Clinical Management turnaround time.
Project Management
Over 20 years of industry experience

Experience in execution of more than 500 clinical trials for different regulatory
authorities

Services: Development and Execution of Phase I to IV Clinical trials


Phase I: Dose escalation studies, PK studies
Phase II: Proof of concept and Dose ranging studies
Phase III: Large Scale Global Efficacy trails to Quality of Life Studies
Phase IV: PMS studies, Observational Studies, New Indication studies,

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Bio-analytical Research

Experience
Bioanalytical
Over 20 years of industrial experience
Subject sample analysis Provide complete range of analytical solutions
Method Development from Lead optimization to Clinical development
Method Validation Equipped with advanced bio-analytical
Tech transfer instruments and an efficient work force.
Experience in handling nearly 300 methods.

Facilities
Provisions for handling of both normal and light sensitive molecules
New Method development and validation is continuous process
Method validations as applicable regulatory guidelines and all processes as
per GLP

Sample storage area with 24X7 receipt and


monitoring
All refrigerators with 21 CFR Compliant data logger
All areas of Bio-analytical lab connected to the
Eurotherm

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Regulatory Affairs
Regulatory Affairs
Regulatory Affairs Compile Dossiers for New Product Launch
Post Approval Changes, Gap Analysis and HA Responses
Regulatory Affairs
Bibliographic and Line Extension Applications
Regulatory strategy and
Intelligence CMC Change Controls and Variations
Regulatory Writing Clinical Trial Application Dossiers
Regulatory Operations
Regulatory Labeling Regulatory Writing
Reg. business and Clinical Study Synopsis, Protocols and Amendments
Outsourcing consultancy Investigator Brochures, Informed Consent Documents
Clinical Study Reports (CSRs); Phases I to IV and BA/BE
Clinical Trial Registries and Results Disclosure
Drug Master File (DMF) & Investigational Medicinal Product
Dossier (IMPD)
Safety and Patient Narrative Writing
SAE reports for Health Authorities and IRBs Submission
Regulatory Operations
Publishing Services (eCTD, NeeS, Paper)
SPL Submission Services
Artwork Services
Product Lifecycle Management

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Regulatory Affairs
Regulatory Affairs Strategy and Intelligence
Regulatory Strategic Planning for New Product Development and Launch
Regulatory Affairs New Market Regulatory Strategy Intelligence
Regulatory strategy and Specialized Strategic Planning for Fast Tracked and Orphan Products
Intelligence
Access, Summarize and Assess Global Regulatory Intelligence
Regulatory Writing
Regulatory Operations Labelling
Regulatory Labeling
Company Core Data Sheet (CCDS)
Reg. business and
Outsourcing consultancy Local Product Labels
Summary of Product Characteristics (SmPC)
Patient Leaflets, Inner and Outer Package Labels
Product Information File (PIF), SPL creation
Supporting Documentation (Clinical and Non-clinical Overviews)

Business and Outsourcing Consultancy


Regulatory Business Strategy Consultancy
Regulatory Compliance Consultancy
Regulatory Centralization
Regulatory Outsourcing Services

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Medical Writing
Commercialization Writing Medical Writing
Medical Writing Manuscripts Consensus guidelines/
Book chapters statements
Commercialization Continuing Medical Education
Review articles
Writing (CME) slide sets
Monographs
Medical Writing Compendiums
Abstracts
Technical Writing Pre/Post conference reports
Posters
Customized Writing Patient educational material
Short summary of manuscripts
Slide sets
News letters

Customized Writing Technical Writing


Training and publication plan Global response letters
development Internal meeting brochures
Graphic support and slide presentations
Literature search and Detailing aids
hyperlinking
Editing and quality reviews
Journal submission assistance

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Medical Writing

56 54

45

27 27

17 19
16 14
8 8
5 2 2 3 1

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Medical Writing Therapeutic Experience

300 Scientific Writing Projects

40% 15% 15% 10%

Endocrinology Oncology Hematology Cardiology 5%

Orthopedics
5% 5% 5% 5%
Nutrition Gastroenterology Health
Women's Health
Outcomes

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Clinical Data Management (CDM)
CDM
Data management
Biostatistics and
statistical programming
services

Study Start up Study Conduct Review Close-out

CRF/e-CRF Designing Double data entry and QC and database audits Interim database
Data Management Plan verification Adverse events closure
Database design and Set- Data Loading Evaluation of medical QA, QC Audits
up Data review and query and scientific consistency Database lock
Import/Export setup management of data Analysis and report
Dictionary set up SAE reconciliation Periodic review for
(MEDRA) Clinical data coding protocol adherence, data
CRF Tracking setup entry and regulatory file
maintenance

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Clinical Data Management (CDM)

Biostatistics and Statistical Programming Services (BSP)


Study Design
CDM Sample size calculations
Data management Scientific inputs in protocols
Biostatistics and SAP Development
statistical programming PK/PD analysis
services Statistical report preparation
SAP Program & Interim Analysis
Support for regulatory and advisory meetings

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Pharmacovigilance

Pharmacovigilance
Case processing
Aggregate reports
Signal detection and Risk
management plans

Triage & Case Medical Quality Regulatory


Case receipt
validation processing Review control Submission
Clinical Trials Validity by Data Entry Qualified Quality review Generate
Literature Identifiable Client Specific Physician on Serious outputs
Regulatory reporter Database Review Case cases according to
Call center Identifiable Argus Narration Data Lock regulatory
Sponsor patient WHO DD Finalize & Ensure requirement
Social Media Identifiable MedDRA confirm compliance Submissions
Drug Subscription Causality before through
Associated AE for journals submission Gateway
Triage by Case Closure
Prioritizing
the case
according to
reporting
timelines
Allocation of
resource

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Why Jeevan ???

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Contact Us

For Business :
Mr. Vasudev Sureddy
: +91 40-30912999
: +91-76590 11000
: vasudev.sureddy@jeevanscientific.com
: info@jeevanscientific.com

Address:
Jeevan Scientific Technology Limited
Plot No. 1&2, Sai Krupa Enclave
Near Lanco Hills, Golconda post
Hyderabad - 500 008
Telangana., India.

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
THANK YOU

www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM