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www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
� Full Service CRO Serving Life Sciences Industry since
January 28, 2005
� ISO 9001:2008, WCA Certified
� Serving 8 of the top 10 Global Pharmaceutical companies
� Global Offices:
� New Jersey, USA
� New Delhi, India
� Sao Paulo, Brazil
� Singapore
� Beijing, China
� One of the “Smallest Global CRO in the world”
ABOUT US
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
GLOBAL COMPANY : GLOBAL REACH
NEW JERSEY
BRAZIL
INDIA
SINGAPORE
CHINA
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
OUR JOURNEY
2005• Tech Observer founded in New Jersey, USA
2008• Tech Observer opens New Delhi, India office
2012• Tech Observer acquires R2T- local Singapore CRO
2012• Tech Observer open its office in Sao Paulo, Brazil
2015• Tech Observer open its office in Beijing, China
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
OUR SERVICES
� Medical Affairs
� Clinical Research
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
MEDICAL AFFAIRS
Phase I-III Phase IV
Medical Research
Medical Affairs
Support
Shaping Market Building Brand
PMS / Investigator initiated studies
Registry studies/ Observational
studies
Medical and Scientific Communication
Health Economics and Outcome Research
Conferences and Event Coverage
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
MEDICAL AFFAIRS SUPPORT
For phase IV/PMS, Investigator initiated studies, Registry studies,
Observational studies, non-interventional studies, Surveys, we provide
support in:
Designing
Study
Concept
Protocol
Synopsis
Sample Size
Calculation
Protocol
Writing
ICF and CRF
designing
Data
Manageme
nt
Statistical
Analysis
CSR Writing
Publication
Support
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MEDICAL & SCIENTIFIC COMMUNICATION
� Medical Education Programme
1. Product Branding
2. Conference Materials
� Publication Planning & Support
� Journal articles
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MEDICAL EDUCATION PROGRAMME
Product Monographs
Product branding and High
impact Slide sets
Product revitalization
programs
Pharma sales rep training
material
Product Information
Leaflets (PIL)
Q&A Documents
ProductBranding
Meeting materials
(Invites, Program
cards Abstracts)
Exhibition Stand
Materials
Electronic
platforms - video/
website,
interactive media
Conferences,
Advisory Board
PresentationsConference Materials
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
Our EXPERIENCE in PUBLICATION
� Journals
1. Original Research Articles
2. Review Articles
3. Editorials
4. Case Reports
� Primary Manuscript and Review Manuscripts
� Posters
� Abstract
� Newsletters
� Advertorials
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HEALTH ECONOMICS AND OUTCOME
RESEARCH
� Cost Effectiveness studies & Other Economic Models,
� Literature Review (Systematic Review & Meta Analysis),
� Value Dossiers ( Both country specific & Global),
� Comparative Effectiveness Research,
� Patient Reported Outcome studies,
� Retrospective Database studies
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
CONFERENCES AND EVENTS COVERAGE
Pre- Meeting Activities
Pre- meeting Planning
,Identification & Profiling
Faculty Management
Designing & Developing Meeting Materials
Building relationships with KOLs
Onsite Meeting Activities
Attending Events/Meetings
Papers Reviews
Case Studies
Conference Materials
Monographs
Videos
Slide sets
Post Meeting Activities
Submission of Final Meetings Reports or Competitive Intelligence reports in the required Format
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
CLINICAL RESEARCH SERVICES
� Medical Writing
� Clinical Data Management
� Biostatistics & SAS Programming
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
MEDICAL WRITING
� Protocol review and development from phase I to IV
� Clinical Study Report (CSR) from Phase I to IV
� Informed Consent form (ICF)
� Investigator Brochures
� Patient Safety Narratives
� Slide Presentations (Original Research/Symposia/Round Table/
Advisory Boards)
� Marketing Materials (Advertisements/ Public Relation material)
� Periodic Safety Update reports
� ISS/ISE
� Regulatory Writing
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
MEDICAL TRANSLATION AND
VALIDATION
As per Good Clinical Practice (GCP) guidelines all documentation and
information in a clinical trial be written and delivered in the participant’s
native language. Thus when clinical trials happen at global level and in
multiple countries involving large number of people speaking different
languages, it becomes highly important for sponsor companies to make
sure that data is available in the language that is easily understandable.
We at Tech observer, having over 10 years of experience in handling global
level clinical trials knows the importance of it and thus makes sure the
sponsor company that is working with us does not face such an issue.
Hence we put forward our Medical Translation services and back
translation.
Currently we are supporting translation in languages: Spanish, Portuguese,
English, Chinese, Deutsch, Italian and Japanese for any Clinical
documents.
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
CLINICAL DATA MANAGEMENT
� CRF/eCRF Design
� Database creation and maintenance
� Data Entry (double)
� Quality Assurance (edit checks, discrepancies management)
� Medical Coding (MedDRA, WHODD)
� SAE Reconcilliation
� Data lock, audit and export
21CFRPart11 Validated CDM Systems OC, OC/RDC, Medidata Rave, INFORM
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
BIOSTATISTICS & SAS PROGRAMMING
� SAP Creation & TLF Shells
� Sample Size Calculation
� Study Design Input & Statistical Section
� DSMB/DMC Support
� Double Programming & Interim Analysis
� CDISC Compliance
� Statistical Report
21CFRPart11 Validated Stats System: SAS Software - version 9x
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
SOP DEVELOPMENT
Standard Operating Procedures (SOPs) are uniformly written
procedures, with detailed instructions to record routine
operations, processes and practices followed within a
business organization.
Our Quality Assurance team along with inputs from each
department like Clinical Operations, Data Management,
Statistical Analysis, Medical Writing and Medical affairs can
build new SOP’s for you and/or even review the already
established SOP’s.
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
OVERALL EXPERIENCE
� Total Ongoing studies : 45+
� DM, BS & MW Projects : 30+
� DM, BS & MW (stand alone) :15+
� Below are few major studies we are covering at present:
Therapeutic
Area/Indication
Phase/Type of
Study
Services rendered Region
Oncology Phase III DM, BS, MW and PM Asia Pacific
Oncology Phase IV DM, BS, MW and PM Asia Pacific
Dermatology Phase IV DM, BS and MW Asia Pacific
Neuro -Psychiatry Phase IV DM, BS and MW Asia Pacific
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Therapeutic Area/
Indication
Phase/Type of
Study
Services
rendered
Region
Endocrinology Phase IV DM, BS and MW Asia Pacific
Arthritis Phase IV DM, BS and MW Latin America
Cardiology Phase IV DM, BS and MW Asia Pacific
Ophthalmology Phase IV DM, BS and MW Asia Pacific
OVERALL EXPERIENCE
� Completed more than 350+ projects for Medical affairs activities like
Primary and review manuscript, Posters, Abstract, Review articles,
Advetorials, Slide Kits, Journals and other marketing as well as
patient education materials.
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
THERAPEUTIC EXPERIENCE
19%
11%
9%
4%
6%7%
5%
4%
3%
5%
7%
3%
4%
2%
3%
2%
1% 1%
3%
1% Oncology
CNS
Cardiovascular
Hepatology
Diabetes
Dermatology
Infectious diseases
Nutrition
Pain Inflammation
Gastroenterology
Endrocrinology
Gynaecology
Musculoskeletal
Respiratory
Psychiatry
Orthopaedic
Nephrology
Opthalmology
Haematology
General Medicine
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
0
5
10
15
20
25 Book chapter
Medical Content
Case report
PPT speaker notes
Editorial
Market research Report
Review Article
Bibliography
Abstract
Corporate reports
SAP
FAQ Design
PPT
Procol synopsis
Protocol Review
Guidelines
CRF
ICD
Poster
Result Synopsis
Data output
CSR
Protocol
Data analysis and Research Article
Manuscript
Medical Affairs Experience in various therapeutic
areas as per servicesWe have completed more than 350+ projects for Medical affairs activities like
Primary and review manuscript, Posters, Abstract, Review articles, Editorials, Slide
Kits, Journals and other marketing as well as patient education materials.
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
Global Clientele's
OnyxAlcon
Lundbeck
Baxter
Hoffman La-Roche Novartis
AstellasStryker
Takeda
J&JMundipharma
Genzyme
Boehringer-Ingelheim
Leo Pharma
Biogen IDEC
Novo NordiskAstraZenecaSanofi
GSK
Many More…
Bayer
OUR CLIENTELE’s
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
Why TECH OBSERVER ?
End to End Support
in Medical Affairs
and Medical
Communication
Global
Footprint &
Local Pricing
20+ SME and
Medical
Communicator
s
Complete
Spectrum of
Therapeutic
Experience
Late Phase
Competency
Innovative &
Tailor made
Startegic
Solutions
Shorter
Decision
Making
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
Our QUALITY COMMITMENT
� ISO 9001: 2000, WCA certified with comprehensive QMS System
� Comprehensive ICH-GCP based SOP’s
� Conduct Regular Internal Audits- Project, System & Facility
� Continuous Trainings & Workshops at all level of employee
� Intense Induction & Refresher Training on Regular Basis
� Security Access to the Facility (card) and Data (Biometrics)
� Maintaining Document Control Procedures/ Archival Room
� Always Audit Ready- Conduct of External Audits and/or Inspections
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
Finally
Unlike larger CROs, failure to meet
expectations is simply NOT an option for
Tech Observer!
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
OUR OFFICES
Brazil Office
Avenida Paulista, 2300
– Andar Pilotis
Cerqueira cesar, Sao
Paulo- Brazil
CEP- 01310- 300
Ph: + 55 11 2847 4965
India Office
1391/34 A Nangal Raya
New Delhi- 110046,
India
Ph: +91 11 28524382
Fax: +91 11 45150926
Global Headquarters
40 Eisenhower Drive,
Suite# 201, Paramus, NJ
07652
Ph: +1 201 489 7705
Fax: +1 201 215 9587
Singapore Office
1004 Toa Payoh North
Unit 06-08a
Singapore 318995
Ph: +65 96434259
China Office
6/F, Tower 2, Prosper
Center, 5 Guanghua
Road,
Chaoyang District,
Beijing, 100020
Chaoyang, 100020
China Ph: +86 (10)
8573 1434
www.tech-observer.com | © 2015 Tech Observer. All rights reserved.
THANK YOU !!