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Global Clinical Development Partner

Providing Quality Clinical Research


Solutions
Table Of 2

Contents

The Veeda Infrastructure


Advantage
Corporate Peopl
Overview e
Quality at Clients and
Veeda Awards
Experien
ce
The Veeda 3

Advantage
Extensive
Scientific Competence Independent
to service a Diverse CRO
client base

High Customer Robust Quality &


Centricity and Regulatory Compliance
Satisfaction

Skilled personnel with


One stop solution for
focus on Continuous
Complex Studies
Professional Development
4

CORPORATE
OVERVIEW
Evolutio 5

n
Privately owned,
New Facility at
board managed
First regulatory inspection from New Facility at Mehsana, Total
company Founded at Shivalik
Vedant number of
with WHO, US FDA & UK
Employees 970
37 Employees MHRA

2004 2006 200 201 2015 201


Ahmedaba 7 0 2018 9
d
First regulatory inspection from New Facility at
ANVISA Insignia
 New Facility at
Skylar, Exclusively
for Screening
 CX Partners join

Corpor Focus on Organic and Inorganic growth


strategies to enhance service
Operational Stability based on experienced
professional management and strong quality

ate capabilities
Financial Stability based on prudent
culture
Ongoing investments in technology to
Outlook management & Private Equity
sponsorship
enhance operating efficiencies and
compliance management
Corporate 6

Philosophy
MISSION & VISION
To strive for Excellence in Quality and Endeavour to become the Partner of choice
for our Sponsors and our Stakeholders

VALUE
S

Humility Opennes Honesty Excellenc Innovation Nurturing Individual


s and e Growth
Integrity
Quality 7

Structure
“Veeda’s management is committed to continuous improvement in the effectiveness of our Quality culture,
to Balanced Score Cards
providing quality research solutions that meet sponsor and regulatory requirements and to protecting (BSC) for
the rights, safety and well being of the study volunteers” augmenting
corporate strategy

Quantifiable Performance
Quality Metrics for all
Policy departments
 Comprehensive system
Quality with more than 350 SOPs
Manageme  QC & QA monitoring Individual KPI’s &
nt System KRA’s linked to BSC
 Monthly Quality Review
Meetings
Quality
 CAPA Management
Culture
Continuous
process
improvement

Focus on implementing policies & nurturing individual behavior to sustain our culture of quality
Regulatory 8

Credentials
 68 successful regulatory audits till date
 26 successful regulatory audits in last 24
months

33* 1

3 1

8 1

5 13

*FDA : 17 AUDITS FOR PATIENT BASED STUDIES


16 AUDITS FOR HEALTHY SUBJECTS
Experienc 9

eBA/BE 1012
Pilot
studies 12 Glucose Clamps
studies (700 clamps)
Total 19 Inhalation
1632 323 588 Standalone Bio- 45 Special Studies
Pivotal Analytical Studies
2 *Both Pilot and Pivotal BA/BE 4
14 FTF Suppositories
Studies
88 Complex Clinical 10 Patches
Studies Studies

Patient based studies


Type of No. of Therapeutic
Study Studies Segment
Global multi-centred Phase II clinical Complete 04 Oncolog
trials d y
Ongoin 02 Oncology and
g CVS
PK Clinical Complete 22 Oncology (14), Psychiatry (6), Rheumatology & Dermatology (1), HIV
Trials d (1)
Ongoin 08 Oncology (6), Psychiatry (1), Gynaecology
g (1)
Phase III studies of injectable 02 Bone
implants disease
Stand-alone Medical writing BE-PK 04 Psychiatry and
studies oncology
10

INFRASTRUC
TURE
Clinical 11

Infrastructure
VEDANT SHIVALIK Spread across 17
Clinical, Bioanalytical Dedicated
Clinical
clinics
with administrative
offices facility
Vedant
MEHSANA INSIGNIA 170 Beds +
Clinical and Dedicated Shivalik 6 Special care
Screening Bioanalytical facility
502 Beds
facility 170 Beds + beds
+
7 Special care beds
20Speci
SKYLAR ARCHIVES 12 Intensively monitored Mehsana
beds al
Common screening
facility for both Shivalik
Internal archival area in
each facility. to conduct Phase I study care beds 162 Beds +
and Vedant Separate long term
archival facility at 7 Special care
Mehsana and Unjha
beds
Bioanalytical 12

Infrastructure Storage Capacity


 46 LC-MS/MS machines Plasma Sample:
45 Deep freezers with capacity to store 11,25,000
 Insignia - 33
samples at -80 C‫ﹾ‬
 Vedant - 13
IP Storage:
 API  3 Walking type stability chambers with overall
5500/4000/3200/3000/2000 capacity to store 34000 Ltr for retention at room
temperature
 Shimadzu 8060/8050/8040
 Quattro Premier  4 Humidity chambers with overall capacity of 3200
Ltr

 4 Pharmaceutical refrigerators having storage


 2 ICP-OES capacity of 3550 Ltr at 2-8 C‫ﹾ‬

 Watson LIMS Archival: Capacity to archive approximately 51000 files


13

CAPABILITIE
S
BA/BE 14

Capabilities
Volunteer Database (More than
53,900)
Male Volunteers >47,00
Complex 0

studies:
Cotinine free studies Female Volunteers >3,800
 High number of ambulatory
Elderly
samples Males
>1,600
 Long Washout periods
Post - Menopausal >1,500
FTF Females

studies

Intensive Safety Routes of


Monitoring administration
20 different dosage forms
 Inhalation
 Transdermal Patches
 Rectal/Vaginal suppositories
 Orals
 Glucose clamps
 LAIs
Patient Trials 15

capabilities
Therapeutic
Expertise
Oncolog Psychiatr
y
 Chronic myeloid leukaemia (CML)
y
 Schizophrenia
 Metastatic Breast Cancer  Epilepsy
 Non – small cell lung cancer  Alzheimer
(NSCLC)
Clinical End Phase II / Phase  Renal cell carcinoma (RCC)
point studies III studies
 Colorectal Cancer
 Small cell lung cancer (SCLC)
 Ovarian Cancer

Cardiology, Immunology (HIV), Dermatology,


Rheumatology,
Gastroenterology, Orthopaedics Ophthalmology, ENT etc
PK / PD End Diverse Routes
point studies of
administration • Extensive Investigators network and experienced project management
team
• eCTD compilation and data management
Bioanalytical 16

Capabilities
Types of Methods
Total available Bioanalytical methods are more than
850 State of the art
731  Capability to develop methods with
Generics 63 Comple
+ + PD/IM x
lowest quantification level- up to 0.1 pg
 Methods developed for:
19  Endogenous molecules
 Hormones
 Steroids
63 NCE 2 MD/M  Inhalation formulation
s V
7  Elemental Bioanalysis
 Immunogenicity
 Large
molecules/ECLIA/ELISA
Bioanalytical Salient  Multiple analysis in single injection
Features  Central labs for Phase II / Phase III
 Average capacity of 1,00,000 samples per studies
month
 Tissue distribution studies
 Central Bioanalytical Laboratory
Biopharmaceutics and Project 17

Management

Study Regulator eCTD


Designing y compilation

Medical PK and stats


Writing Data
evaluation
Training & 18

Development
12 Continuous Professional Development (CPD) program
topics/year/department Peopl
e
5 6
Dedicated Training Laboratory with
world class features
MD PH

D
ACLS/BLS training conducted every
quarter

eModules Training done through


iPads

GCP/GLP training conducted externally once every


year SOP training conducted on an ongoing basis
22 M BB 71 OTHER
S
S
5
19

CLIENTS AND
AWARDS
Cliente 20

le Revenue Generation by Client


Size

Overall Mid-Size Large size /


Clients MNC(s)
Customer 30 36
Retention Rate % %
>90% Small
Client 34
90% of the revenue s
Total Clients
%
Clients Active
comes fromExisting clients in the Past
9 ROW year
3 ROW
Indi U Indi U
a 142 S a S

130 58 41
54 19
89 1
E
Chin Chin 6 E
U
Achievement 21

s Organization Award Category

Best Clinical Research Organization - India

Clinical Trial Company of the Year

Bharat Udhyog Ratan Award in


Clinical Research

14YE A R 200
201
7
201 201
9
+
S
4 Organization Award
8
Organization Award
Category Category
National Excellence
Award Best Quality Clinical
Research Organization in
Best Pharmaceutical India
CRO
Health & Safety Best Clinical Research- Best Quality Clinical
Awards India Research
Best Clinical Research- India Organization in India

Mark of Excellence

Indian Clinical Research


company of the year