Tech Observer

Capability Presentation

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


GLOBAL COMPANY : GLOBAL REACH

NEW JERSEY

BRAZIL

INDIA

SINGAPORE

CHINA


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


OUR SERVICES

� Medical Affairs

� Clinical Research


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


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


MEDICAL & SCIENTIFIC COMMUNICATION

� Medical Education Programme

1. Product Branding

2. Conference Materials

� Publication Planning & Support

� Journal articles


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


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


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


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


CLINICAL RESEARCH SERVICES

� Medical Writing

� Clinical Data Management

� Biostatistics & SAS Programming


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


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.


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


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


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.


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


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.


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


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.


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


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


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


Finally

Unlike larger CROs, failure to meet

expectations is simply NOT an option for

Tech Observer!


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


THANK YOU !!

Tech Observer

Documents

Transcript of Tech Observer