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Global Clinical Development Partner
Providing Quality Clinical Research Solutions
Table Of Contents 2
Infrastructure
People
Clients and Awards
The Veeda Advantage
Corporate Overview
Quality at Veeda
Experience
The Veeda Advantage 3
Independent CRO
Robust Quality & Regulatory
Compliance
One stop solution for Complex
Studies
Extensive Scientific
Competence to service a
Diverse client base
High Customer Centricity
and Satisfaction
Skilled personnel with focus
on Continuous Professional
Development
4
CORPORATE OVERVIEW
Focus on Organic and Inorganic growth
strategies to enhance service capabilities
Financial Stability based on prudent
management & Private Equity sponsorship
Corporate
Outlook
Operational Stability based on experienced
professional management and strong quality culture
New Facility at Insignia
Founded at Shivalik with
37Employees
New Facility at VedantFirst regulatory inspection from
WHO, US FDA & UK MHRA
First regulatory inspection from ANVISA  New Facility at Skylar,
Exclusively for Screening
 CX Partners join
New Facility at Mehsana,
Total number of
Employees 970
2004 2006 2007 2010 2015 2018 2019
Ongoing investments in technology to enhance
operating efficiencies and compliance
management
Evolution 5
Privately owned, board
managed company
Ahmedabad
MISSION & VISION
To strive for Excellence in Quality and Endeavour to become the Partner of choice for
our Sponsors and our Stakeholders
Corporate Philosophy 6
InnovationHumility Openness Nurturing Individual
Growth
Excellence
VALUES
Honesty and
Integrity
 Comprehensive system with
more than 350 SOPs
 QC & QA monitoring
 Monthly Quality Review
Meetings
 CAPA Management
Focus on implementing policies & nurturing individual behavior to sustain our culture of quality
Quality Structure 7
Balanced Score Cards
(BSC) for augmenting
corporate strategy
Individual KPI’s & KRA’s
linked to BSC
Continuous process
improvement
Quantifiable Performance
Metrics for all
departments
“Veeda’s management is committed to continuous improvement in the effectiveness of our Quality culture, to
providing quality research solutions that meet sponsor and regulatory requirements and to protecting the
rights, safety and well being of the study volunteers”
Quality Culture
Quality
Management
System
Quality
Policy
 68 successful regulatory audits till date
 26 successful regulatory audits in last 24 months
33*
8
3
8
3
5
1
1
1
13
Regulatory Credentials 8
*FDA : 17 AUDITS FOR PATIENT BASED STUDIES
16 AUDITS FOR HEALTHY SUBJECTS STUDIES
BA/BE studies
1632 Pivotal
1012 Pilot
45 Special Studies588 Standalone Bio-Analytical
Total
3232
12 Glucose Clamps studies
(700 clamps)
19 Inhalation Studies
4 Suppositories
10 Patches Studies
Patient based studies
Type of Study No. of Studies Therapeutic Segment
Experience 9
Global multi-centred Phase II clinical trials
PK Clinical Trials
Phase III studies of injectable implants
Stand-alone Medical writing BE-PK studies
Oncology
Oncology and CVS
Oncology (14), Psychiatry (6), Rheumatology & Dermatology (1), HIV (1)
Oncology (6), Psychiatry (1), Gynaecology (1)
Bone disease
Psychiatry and oncology
04
02
22
08
02
04
88 Complex Clinical Studies
14 FTF Studies
Completed
Ongoing
Completed
Ongoing
*Both Pilot and Pivotal BA/BE
10
INFRASTRUCTURE
7 Special care beds
Clinical Infrastructure 11
Spread across 17 clinics
170 Beds +
12 Intensively monitored beds
to conduct Phase I study
Shivalik 6 Special care beds
170 Beds +
Vedant
502Beds +
20Special
care beds
Mehsana
7 Special care beds
162 Beds +
VEDANT
Clinical, Bioanalyticalwith
administrative offices
SHIVALIK
Dedicated Clinical
facility
INSIGNIA
Dedicated Bioanalytical
facility
SKYLAR
Common screening facility
for both Shivalik and
Vedant
ARCHIVES
Internal archival area in
each facility.
Separate long term archival
facility at Mehsana and
Unjha
MEHSANA
Clinical and Screening
facility
 46 LC-MS/MS machines
 Insignia - 33
 Vedant - 13
 API 5500/4000/3200/3000/2000
 Shimadzu 8060/8050/8040
 Quattro Premier
 2 ICP-OES
 Watson LIMS
Bioanalytical Infrastructure 12
Storage Capacity
Plasma Sample:
45 Deep freezers with capacity to store 11,25,000 samples
at -80 C‫ﹾ‬
IP Storage:
 3 Walking type stability chambers with overall capacity
to store 34000 Ltr for retention at room temperature
 4 Humidity chambers with overall capacity of 3200 Ltr
 4 Pharmaceutical refrigerators having storage capacity
of 3550 Ltr at 2-8 C‫ﹾ‬
Archival: Capacity to archive approximately 51000 files
13
CAPABILITIES
BA/BE Capabilities
VolunteerDatabase (More than 53,900)
Routes of administration
Complex studies:
 Cotinine free studies
 High number of ambulatory samples
 Long Washout periods
FTF studies
Intensive Safety Monitoring
20 different dosage forms
Male Volunteers
Female Volunteers
Elderly Males
Post - Menopausal Females
>47,000
>3,800
>1,600
>1,500
14
 Inhalation
 Transdermal Patches
 Rectal/Vaginal suppositories
 Orals
 Glucose clamps
 LAIs
Patient Trials capabilities
Clinical End point
studies
Phase II / Phase III
studies
PK / PD End point
studies
Diverse Routes of
administration
• Extensive Investigators network and experienced project management team
• eCTD compilation and data management
Cardiology, Immunology (HIV), Dermatology, Rheumatology,
Gastroenterology, Orthopaedics Ophthalmology, ENT etc
Therapeutic Expertise
 Schizophrenia
 Epilepsy
 Alzheimer
PsychiatryOncology
 Chronic myeloid leukaemia (CML)
 Metastatic Breast Cancer
 Non – small cell lung cancer (NSCLC)
 Renal cell carcinoma (RCC)
 Colorectal Cancer
 Small cell lung cancer (SCLC)
 Ovarian Cancer
15
Bioanalytical Capabilities
State of the art
 Capability to develop methods with lowest
quantification level- up to 0.1 pg
 Methods developed for:
 Endogenous molecules
 Hormones
 Steroids
 Inhalation formulation
 Elemental Bioanalysis
 Immunogenicity
 Large molecules/ECLIA/ELISA
 Multiple analysis in single injection
 Central labs for Phase II / Phase III studies
 Tissue distribution studies
Bioanalytical Salient Features
 Average capacity of 1,00,000 samples per month
 Central Bioanalytical Laboratory
Types of Methods
NCEs63 27 MD/MV
Complex63Generics +
PD/IM
731 +
19
16
Total available Bioanalytical methods are more than 850
16
Study Designing
PK and stats Data
evaluation
Medical Writing
eCTD compilationRegulatory
Biopharmaceutics and Project Management 17
12 Continuous Professional Development (CPD) program
topics/year/department
eModules Training done through iPads
ACLS/BLS training conducted every quarter
GCP/GLP training conducted externally once every year
SOP training conducted on an ongoing basis
Dedicated Training Laboratory with world
class features
Training & Development 18
6 P H D5 M D
22 M B B S 715 OTHERS
People
19
CLIENTS AND AWARDS
Clientele
Large size /
MNC(s)
Mid-Size
Clients
Small
Clients 34%
30% 36%
Clients Active
in the Past year
Total Clients
Overall Customer
Retention Rate
>90%
90% of the revenue comes
from Existing clients
130
54
89
142 58 41
19
16
IndiaUS
China
EU
India US
China EU
Revenue Generation by Client Size
ROW ROW9 3
20
14+Y E A R S 2004
2017
Organization Award Category
Best Quality Clinical Research
Organization in India
Best Quality Clinical Research
Organization in India
2018
Organization Award Category
National Excellence Award
Best Pharmaceutical CRO
Health & Safety Awards Best Clinical Research- India
Best Clinical Research- India
Mark of Excellence
Indian Clinical Research company
of the year
2019
Organization Award Category
Best Clinical Research Organization - India
Clinical Trial Company of the Year
Bharat Udhyog Ratan Award in Clinical
Research
Achievements 21

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Best babe cro in india

  • 1. Global Clinical Development Partner Providing Quality Clinical Research Solutions
  • 2. Table Of Contents 2 Infrastructure People Clients and Awards The Veeda Advantage Corporate Overview Quality at Veeda Experience
  • 3. The Veeda Advantage 3 Independent CRO Robust Quality & Regulatory Compliance One stop solution for Complex Studies Extensive Scientific Competence to service a Diverse client base High Customer Centricity and Satisfaction Skilled personnel with focus on Continuous Professional Development
  • 5. Focus on Organic and Inorganic growth strategies to enhance service capabilities Financial Stability based on prudent management & Private Equity sponsorship Corporate Outlook Operational Stability based on experienced professional management and strong quality culture New Facility at Insignia Founded at Shivalik with 37Employees New Facility at VedantFirst regulatory inspection from WHO, US FDA & UK MHRA First regulatory inspection from ANVISA  New Facility at Skylar, Exclusively for Screening  CX Partners join New Facility at Mehsana, Total number of Employees 970 2004 2006 2007 2010 2015 2018 2019 Ongoing investments in technology to enhance operating efficiencies and compliance management Evolution 5 Privately owned, board managed company Ahmedabad
  • 6. MISSION & VISION To strive for Excellence in Quality and Endeavour to become the Partner of choice for our Sponsors and our Stakeholders Corporate Philosophy 6 InnovationHumility Openness Nurturing Individual Growth Excellence VALUES Honesty and Integrity
  • 7.  Comprehensive system with more than 350 SOPs  QC & QA monitoring  Monthly Quality Review Meetings  CAPA Management Focus on implementing policies & nurturing individual behavior to sustain our culture of quality Quality Structure 7 Balanced Score Cards (BSC) for augmenting corporate strategy Individual KPI’s & KRA’s linked to BSC Continuous process improvement Quantifiable Performance Metrics for all departments “Veeda’s management is committed to continuous improvement in the effectiveness of our Quality culture, to providing quality research solutions that meet sponsor and regulatory requirements and to protecting the rights, safety and well being of the study volunteers” Quality Culture Quality Management System Quality Policy
  • 8.  68 successful regulatory audits till date  26 successful regulatory audits in last 24 months 33* 8 3 8 3 5 1 1 1 13 Regulatory Credentials 8 *FDA : 17 AUDITS FOR PATIENT BASED STUDIES 16 AUDITS FOR HEALTHY SUBJECTS STUDIES
  • 9. BA/BE studies 1632 Pivotal 1012 Pilot 45 Special Studies588 Standalone Bio-Analytical Total 3232 12 Glucose Clamps studies (700 clamps) 19 Inhalation Studies 4 Suppositories 10 Patches Studies Patient based studies Type of Study No. of Studies Therapeutic Segment Experience 9 Global multi-centred Phase II clinical trials PK Clinical Trials Phase III studies of injectable implants Stand-alone Medical writing BE-PK studies Oncology Oncology and CVS Oncology (14), Psychiatry (6), Rheumatology & Dermatology (1), HIV (1) Oncology (6), Psychiatry (1), Gynaecology (1) Bone disease Psychiatry and oncology 04 02 22 08 02 04 88 Complex Clinical Studies 14 FTF Studies Completed Ongoing Completed Ongoing *Both Pilot and Pivotal BA/BE
  • 11. 7 Special care beds Clinical Infrastructure 11 Spread across 17 clinics 170 Beds + 12 Intensively monitored beds to conduct Phase I study Shivalik 6 Special care beds 170 Beds + Vedant 502Beds + 20Special care beds Mehsana 7 Special care beds 162 Beds + VEDANT Clinical, Bioanalyticalwith administrative offices SHIVALIK Dedicated Clinical facility INSIGNIA Dedicated Bioanalytical facility SKYLAR Common screening facility for both Shivalik and Vedant ARCHIVES Internal archival area in each facility. Separate long term archival facility at Mehsana and Unjha MEHSANA Clinical and Screening facility
  • 12.  46 LC-MS/MS machines  Insignia - 33  Vedant - 13  API 5500/4000/3200/3000/2000  Shimadzu 8060/8050/8040  Quattro Premier  2 ICP-OES  Watson LIMS Bioanalytical Infrastructure 12 Storage Capacity Plasma Sample: 45 Deep freezers with capacity to store 11,25,000 samples at -80 C‫ﹾ‬ IP Storage:  3 Walking type stability chambers with overall capacity to store 34000 Ltr for retention at room temperature  4 Humidity chambers with overall capacity of 3200 Ltr  4 Pharmaceutical refrigerators having storage capacity of 3550 Ltr at 2-8 C‫ﹾ‬ Archival: Capacity to archive approximately 51000 files
  • 14. BA/BE Capabilities VolunteerDatabase (More than 53,900) Routes of administration Complex studies:  Cotinine free studies  High number of ambulatory samples  Long Washout periods FTF studies Intensive Safety Monitoring 20 different dosage forms Male Volunteers Female Volunteers Elderly Males Post - Menopausal Females >47,000 >3,800 >1,600 >1,500 14  Inhalation  Transdermal Patches  Rectal/Vaginal suppositories  Orals  Glucose clamps  LAIs
  • 15. Patient Trials capabilities Clinical End point studies Phase II / Phase III studies PK / PD End point studies Diverse Routes of administration • Extensive Investigators network and experienced project management team • eCTD compilation and data management Cardiology, Immunology (HIV), Dermatology, Rheumatology, Gastroenterology, Orthopaedics Ophthalmology, ENT etc Therapeutic Expertise  Schizophrenia  Epilepsy  Alzheimer PsychiatryOncology  Chronic myeloid leukaemia (CML)  Metastatic Breast Cancer  Non – small cell lung cancer (NSCLC)  Renal cell carcinoma (RCC)  Colorectal Cancer  Small cell lung cancer (SCLC)  Ovarian Cancer 15
  • 16. Bioanalytical Capabilities State of the art  Capability to develop methods with lowest quantification level- up to 0.1 pg  Methods developed for:  Endogenous molecules  Hormones  Steroids  Inhalation formulation  Elemental Bioanalysis  Immunogenicity  Large molecules/ECLIA/ELISA  Multiple analysis in single injection  Central labs for Phase II / Phase III studies  Tissue distribution studies Bioanalytical Salient Features  Average capacity of 1,00,000 samples per month  Central Bioanalytical Laboratory Types of Methods NCEs63 27 MD/MV Complex63Generics + PD/IM 731 + 19 16 Total available Bioanalytical methods are more than 850 16
  • 17. Study Designing PK and stats Data evaluation Medical Writing eCTD compilationRegulatory Biopharmaceutics and Project Management 17
  • 18. 12 Continuous Professional Development (CPD) program topics/year/department eModules Training done through iPads ACLS/BLS training conducted every quarter GCP/GLP training conducted externally once every year SOP training conducted on an ongoing basis Dedicated Training Laboratory with world class features Training & Development 18 6 P H D5 M D 22 M B B S 715 OTHERS People
  • 20. Clientele Large size / MNC(s) Mid-Size Clients Small Clients 34% 30% 36% Clients Active in the Past year Total Clients Overall Customer Retention Rate >90% 90% of the revenue comes from Existing clients 130 54 89 142 58 41 19 16 IndiaUS China EU India US China EU Revenue Generation by Client Size ROW ROW9 3 20
  • 21. 14+Y E A R S 2004 2017 Organization Award Category Best Quality Clinical Research Organization in India Best Quality Clinical Research Organization in India 2018 Organization Award Category National Excellence Award Best Pharmaceutical CRO Health & Safety Awards Best Clinical Research- India Best Clinical Research- India Mark of Excellence Indian Clinical Research company of the year 2019 Organization Award Category Best Clinical Research Organization - India Clinical Trial Company of the Year Bharat Udhyog Ratan Award in Clinical Research Achievements 21