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Best BABE CRO in India

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Veeda CR offers to conduct, manage and monitor Clinical Trials in a wide range of therapeutic areas and monitor BABE studies in India. – PowerPoint PPT presentation

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Title: Best BABE CRO in India


1
Global Clinical Development Partner Providing
Quality Clinical Research Solutions
2
Table Of Contents
2
Infrastructure
The Veeda Advantage
People
Corporate Overview
Clients and Awards
Quality at Veeda
Experience
3
The Veeda Advantage
3
Extensive Scientific Competence to service a
Diverse client base
Independent CRO
High Customer Centricity and Satisfaction
Robust Quality Regulatory Compliance
Skilled personnel with focus on Continuous
Professional Development
One stop solution for Complex Studies
4
4
CORPORATE OVERVIEW
5
Evolution
5
Privately owned, board managed company
New Facility at Mehsana, Total number of
Employees 970
New Facility at Vedant
First regulatory inspection from WHO, US FDA UK
MHRA
Founded at Shivalik with 37 Employees
2004 2006 First regulatory inspection from ANVISA
2007
2010
  • 2015 2018
  • New Facility at Skylar, Exclusively for
    Screening
  • CX Partners join

2019
Ahmedabad
New Facility at Insignia
Corporate Outlook
Operational Stability based on experienced
professional management and strong quality culture
Focus on Organic and Inorganic growth strategies
to enhance service capabilities
Ongoing investments in technology to enhance
operating efficiencies and compliance management
Financial Stability based on prudent management
Private Equity sponsorship
6
Corporate Philosophy
6
MISSION VISION To strive for Excellence in
Quality and Endeavour to become the Partner of
choice for our Sponsors and our Stakeholders
VALUES
Nurturing Individual Growth
Innovation
Humility
Openness
Excellence
Honesty and Integrity
7
Quality Structure
7
Veedas 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
Balanced Score Cards (BSC) for augmenting
corporate strategy
Quantifiable Performance Metrics for all
departments
Quality Policy Quality Management System
  • Comprehensive system with more than 350 SOPs
  • QC QA monitoring
  • Monthly Quality Review Meetings
  • CAPA Management

Individual KPIs KRAs linked to BSC
Quality Culture
Continuous process improvement
Focus on implementing policies nurturing
individual behavior to sustain our culture of
quality
8
Regulatory Credentials
8
  • 68 successful regulatory audits till date
  • 26 successful regulatory audits in last 24 months

1
33
3
1
8
1
5
13
3
FDA 17 AUDITS FOR PATIENT BASED STUDIES 16
AUDITS FOR HEALTHY SUBJECTS STUDIES
9
Experience
9
BA/BE studies
1012 Pilot
12 Glucose Clamps studies (700 clamps)
Total 3232
19 Inhalation Studies
45 Special Studies Both Pilot and Pivotal BA/BE
1632 Pivotal
588 Standalone Bio-Analytical
4 Suppositories
14 FTF Studies
10 Patches Studies
88 Complex Clinical Studies
Patient based studies Type of Study
Therapeutic Segment
No. of Studies
Global multi-centred Phase II clinical trials
Oncology
04
Completed
Oncology and CVS
02
Ongoing
PK Clinical Trials
Oncology (14), Psychiatry (6), Rheumatology
Dermatology (1), HIV (1)
22
Completed
Oncology (6), Psychiatry (1), Gynaecology (1)
08
Ongoing
Phase III studies of injectable implants
Bone disease
02
Stand-alone Medical writing BE-PK studies
Psychiatry and oncology
04
10
10
INFRASTRUCTURE
11
Clinical Infrastructure
11
VEDANT Clinical, Bioanalytical with
administrative offices
SHIVALIK Dedicated Clinical facility
Spread across 17 clinics
Vedant 170 Beds 6 Special care beds
INSIGNIA Dedicated Bioanalytical facility
MEHSANA Clinical and Screening facility
Shivalik 170 Beds 7 Special care beds 12
Intensively monitored beds to conduct Phase I
study
502 Beds 20Special care beds
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 162 Beds 7 Special care beds
12
Bioanalytical Infrastructure
12
  • Storage Capacity
  • Plasma Sample
  • 45 Deep freezers with capacity to store 11,25,000
    samples at -80 C?
  • 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 C?
  • Archival Capacity to archive approximately 51000
    files
  • 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

13
13
CAPABILITIES
14
BA/BE Capabilities
14
Volunteer Database (More than 53,900)
Male Volunteers
gt47,000
Complex studies
  • Cotinine free studies
  • High number of ambulatory samples
  • Long Washout periods

Female Volunteers
gt3,800
Elderly Males
gt1,600
Post - Menopausal Females
FTF studies
gt1,500
  • Routes of administration
  • 20 different dosage forms
  • Inhalation
  • Transdermal Patches
  • Rectal/Vaginal suppositories
  • Orals
  • Glucose clamps
  • LAIs

Intensive Safety Monitoring
15
Patient Trials capabilities
15
Therapeutic Expertise
Psychiatry
Oncology
  • Schizophrenia
  • Epilepsy
  • Alzheimer
  • 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

Clinical End point studies
Phase II / Phase III studies
Cardiology, Immunology (HIV), Dermatology,
Rheumatology, Gastroenterology, Orthopaedics
Ophthalmology, ENT etc
PK / PD End point studies
Diverse Routes of administration
  • Extensive Investigators network and experienced
    project management team
  • eCTD compilation and data management

16
Bioanalytical Capabilities
16
Types of Methods Total available Bioanalytical
methods are more than 850
  • State of the art
  • Capability to develop methods with lowest
    quantification level- up to 0.1 pg
  • Methods developed for

731 19
63
Complex
Generics PD/IM
  • Endogenous molecules
  • Hormones
  • Steroids
  • Inhalation formulation
  • Elemental Bioanalysis
  • Immunogenicity
  • Large molecules/ECLIA/ELISA

63
27
NCEs
MD/MV
  • 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

17
Biopharmaceutics and Project Management
17
Study Designing
eCTD compilation
Regulatory
PK and stats Data evaluation
Medical Writing
18
Training Development
18
People
12 Continuous Professional Development (CPD)
program topics/year/department
6 P H D
5
Dedicated Training Laboratory with world class
features
MD
ACLS/BLS training conducted every quarter
eModules Training done through iPads
22 M B B S
715
GCP/GLP training conducted externally once every
year SOP training conducted on an ongoing basis
OTHERS
19
19
CLIENTS AND AWARDS
20
Clientele
20
Revenue Generation by Client Size
Overall Customer Retention Rate gt90
Large size / MNC(s)
Mid-Size Clients
30
36
Small Clients
34
90 of the revenue comes from Existing clients
Total Clients 9 ROW 142 130
Clients Active in the Past year 3 ROW 58 41
India
India
US
US
54
19 EU
89
16
EU
China
China
21
Achievements
21
Organization Organization Award Category
Best Clinical Research Organization - India
Clinical Trial Company of the Year
Bharat Udhyog Ratan Award in Clinical Research

14
2017
2019
2018
2004
Y E A R S
Organization
Award Category
Organization
Award Category
National Excellence Award
Best Quality Clinical Research Organization in
India
Best Pharmaceutical CRO
Health Safety Awards
Best Clinical Research- India
Best Quality Clinical Research Organization in
India
Best Clinical Research- India Mark of
Excellence Indian Clinical Research company of
the year
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