Bioinnovat_Corporate_Presentation[1].ppt

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Dec 6, 2012 (4 years and 8 months ago)

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Pharmaceutical Knowledge Resource Organization
BIOINNOVAT
Research Services Pvt. Ltd

Mission
To be a leading knowledge resource organization in drug
development services in India

Leadership in clinical training, placement, regulatory affairs
, marketing research & communication to stakeholders in
biopharmaceutical development.

Core Competency
Business Development strategies with tactical
implementation based on
scientific and therapeutic
expertise,
market intelligence and consistent networking

Core Values
The core values are
innovation
and
consistent

quality
in
process & delivery. We help clients get products to market
faster by identifying and building productive resource
teams and forging strong relationships with the business
and scientific community.
BIOINNOVAT
BIOINNOVAT
About Us

Biopharmaceutical Professional Resource
Organization (PRO)


Founded in July 2005


India centric operations


Offices located in Delhi, Gurgaon,& Mumbai


Service global biopharma & clinical research
organizations with solutions to build
sustainable
businesses
Key Operating Areas

Advisory

Regulatory Affairs

Executive Search & Placement

Contract Staffing – Clinical Research



Education, Professional Skill Development &
Corporate Training

Post graduate Diploma courses in Clinical
Research, Pharmaceutical & Healthcare
Management in partnership with leading public

Universities.
BIOINNOVAT
Advisory
BIOINNOVAT
BIOINNOVAT
Services:


For Global Clinical Research organizations (CROs)

Establish Indian Subsidiaries, Build and Train
Clinical Operations, Data Management, Drug
Safety and Medical Writing Teams

Assisted Kendle on entry in India in 2004/5

Assisted i3 on the entry strategy and supported to start i3
India as full services CRO from 2006-11 growing to 250 +
employees till its merger with Inventiv, Pharmanet.

Representation for licensing / partnering in
Indian market

Source and develop alliances with Indian CROs.

Assisted INC a therapeutic specialist CRO on entry strategy in
India. Initiated 50 :50 Joint venture of INC GVK Bio for clinical
development
BIOINNOVAT

Services:

Business development services For Indian
CROs

Contract Research & Manufacture (CRAM)

Drug development research services
consultancy for setting up CROs

Market Representation : M Scan

Stakeholder communication strategy &
outreach

Oversight of Clinical Trials in India for Global
Sponsors

Management of Clinical trials on behalf of global
sponsors to meet agreed deliverables.

Collaborating with CRO to provide sponsor support on
the ground in regulatory policy impact and site
management.

Have provided oversight for 11 clinical development
programs
Regulatory Affairs: India
BIOINNOVAT
BIOINNOVAT
Regulatory services for clinical trials, market approvals, R&D imports ,
commercial imports & export licenses


Complete dossier preparation and filings


Liason with Central and State Authorities
(DCGI, DGFT, DBT, ICMR,
MOH etc) for:


Global clinical trials Phase II to IV


Market authorizations


BE / BA (Bioequivalence and Bioavailability) studies


CPU (Central Pharmacology Unit) approval


Controlled drug substances from Central Bureau of
Narcotics and State approvals


Drug import licenses and export licenses
Handled 32 global clinical trials in last 12
months
Executive Search & Placement
BIOINNOVAT
BIOINNOVAT
Coverage


All levels (junior to senior management) across all
functions including R&D, sales & marketing, regulatory
&
medical affairs, production, finance & corporate
services

Continuous mapping of senior industry personnel
including business unit heads, medical directors, CSOs,
COOs &CEOs
BIOINNOVAT
Executive Search:
Process
Assessing Client Needs
Candidate Generation - Long-
List
Screening & Short List
Reference Check &
Validation
Negotiation
& Closure
Developing
Database
Ongoing Employee
Training
Sourcing/
Enhancing
Candidate Pool
Servicing Client
Needs
BIOINNOVAT
Executive
Search:
Process

Assessing
client needs –
regular client
meetings/
briefings to
assess role
requirements
and key
characteristics
required by
candidates

Candidate
Generation – 7
dedicated
analysts use
customised
search engine
on company
database of
over 6000
candidates
along with
referrals & own
professional
network.
Analysts also
map
movements of
senior
personnel in
industry

Create shortlist
– each long
listed candidate
is the screened
and assessed
for suitability to
produce
shortlist for
interview

Reference
check and
validation

Negotiations
and closure

Follow-up /
Feedback –in
the eventuality
of attrition
within 6 months
a replacement
is provided .
BIOINNOVAT
Executive Search: Why
Bioinnovat?

Complete recruitment process offered from
sourcing and
screening candidates,
validating references, scheduling interviews,
providing feedback and negotiating packages

Unique search engine run by 7 dedicated
analysts with candidates mapped by
functional expertise, general management
experience & location

Ongoing dialogue with over 25000
biopharmaceutical employees

Customer – focused recruitment. Staff
regularly trained to understand organizational
needs and identify solutions

Complete confidentiality of customer data

At any given point of time, Bioinnovat does
not handle competing / conflicting senior
search assignment
Clinical Research - Contract Staffing
BIOINNOVAT
BIOINNOVAT
Contract Staffing: Clinical Research
Roles
Data Managers /
Biostatisticians
SAS/Oracle trained
Regulatory
Affairs
Technical Specialist
& Assistants
Site Coordinators,
CTA, PRAs
Project
Managers
Senior
CRAs
CRAs upto
2 yr
Quality Assurance
Drug
Safety
Biostatistics &
Medical Writing
Middle
Management;- Medical
Advisors
Clinical Operation
Managers
BIOINNOVAT
Contract Staffing



Bridge staffing needs for short to indeterminate time
gaps

Cover all areas of clinical research including staff with
specific experience, language skills etc



Engagements can be time &/ or task oriented and for

individuals or teams



Several options offered including:



Temp staff on client payroll



Staff on Bioinnovat payroll, located in sponsor
office or home
based



Staff on Bioinnovat payroll located in Bioinnovat
premises



Mentoring, training and oversight of insourced staff


Sponsor can convert to permanent headcount at
anytime


Functional process outsourcing
BIOINNOVAT
Contract Staffing :
Why Bioinnovat?


Experienced & dependable


Quick identification, attraction
and retention of talent


Proactive & responsive


On time and on budget


Access to large pool of
contract and temporary
workers through
education
portal, referral system and own
network


Customized search engine
with large database of over
9000 staff in
clinical
research, 750 investigators
expanding by over 190 every
month


Unique search engine run by
dedicated analysts with
candidates
mapped by
therapeutic area, experience
and geography


Continuous mentoring, training
and oversight of in-sourced
employees


Quick replacement, support
transition to permanent
headcount


Highly flexible arrangements
to suit client needs
BIOINNOVAT
Functional Resourcing : Flexible
Resourcing Services
Bioinnovat has extensive experience in establishing, maintaining
and enhancing productivity & cost efficiency through various
forms of FSP and insourcing models
Flexible Resourcing Services minimizes the resource picking that
occurs within development programs, thus increasing resource
utilisation and significantly decreasing costs. This solution can
include all of the service offerings along with technology systems
and international capabilities
Cross functional service provider & functional service provider
BIOINNOVAT
Key Clients
BIOINNOVAT
Key Clients
Education
Certified Post Graduate Programs
BIOINNOVAT
BIOINNOVAT
Education:


Post Graduate Clinical Development Certified
training
in partnership with University of Pune,
Goa University
& Indira Gandhi National Open
University (IGNOU)
offering Diploma and
Certificate courses in 8 cities


Weekend classes allowing students to work and
gain
experience along with education


Variety of courses offered including Diplomas and
Masters. Coursework divided into semesters
which can
be done at individual’s pace


All teaching done by industry professionals with
minimum 5 years of work experience >120 regular

visiting faculty .


Over 1500+ graduates working in industry
BIOINNOVAT
Offering: University of Pune

Public Private partnership since 2005


Post Graduation Certification in Clinical Research
and Clinical Data Management . Over 1200 alumni
working in over 60 companies in clinical operations
& data management
BIOINNOVAT
Offering: Goa University
Post Graduate Diploma offered in:


Clinical research, advanced monitoring and
site
management


Clinical data management, biostatistics and
SAS
programming


Regulatory affairs and auditing


Pharmacovigilence, drug safety, medical
writing
and scientific publication
BIOINNOVAT
Offering: IGNOU
Tie up since 2010 with Indira Gandhi National
Open University (IGNOU) School of
Paramedical Sciences
Post Graduate Diploma offered in:


Clinical research, advanced monitoring and
site
management


Clinical data management, biostatistics and
SAS
programming


Regulatory affairs and auditing


Pharmacovigilence, drug safety, medical
writing
and scientific publication
Board of Directors
BIOINNOVAT


27 years of experience
in

pharmaceutical and
CRO

industries


CEO of Registrat-Mapi

Europe


Previously at i3
Research

where he was
President,

Strategtic Outsourcing
&

Corporate
Development


Other experience
includes

key roles in Sales &

Marketing, Regulatory,

Clinical Operations,

Systems & Quality

Improvement, IT, M&A

& Senior Management
in

UK, USA and Germany

across pharma sector


Advisor National

Knowledge
Commission,

Govt of India


Former Vice Chancellor,

University of Pune,

Professor in Molecular

Biophysics


Founder, Director of

Bioinformatics Center,

University of Pune


Currently, Managing

Director of DSK

International Institute of

Animation, Gaming &

Industrial Design


Currently serving on

Board of Governors for

IIM Bangalore


28 years experience in

international business,


strategic alliances &

marketing


Senior management

positions at industry

leaders such as
Ranbaxy &

Reliance


Previously Director –

Corporate Affairs at

Monsanto procuring
first

regulatory approval for

ag-biotech products


Founder member of

operating team of
Jubilant

Biosys & spearheaded

diversification of
Jubilant

Organosys in Life
Science
Guljit Chaudhri
Prof. AS
Kolaskar
Nigel Page
BIOINNOVAT
Contact Us
Bioinnovat Research Services
Pvt. Ltd.
Delhi Office:
A-1/17 Safdarjang Enclave
New Delhi - 110029, India
Tel: 91-11-41354135

fax 91-11- 4151 7277
Gurgaon Office:
The Elements,
465

Phase V, Udyog Vihar Ind. Area,
Gurgaon - 122 015 (Haryana),
India
Tel: 91-124- 4309034

91-124-4261316
Mumbai Office:
1002 Sukhada B wing
Sir Poochkanwala Marg
Worli, Mumbai- 400018 India
Ph 91 9004695917
Email:
guljit
@
bioinnovat.com
,
info@bioinnovat.com