Best BABE CRO in India by Veeda Clinical Research

Global Clinical Development Partner Providing Quality Clinical Research Solutions

Table Of Contents

The Veeda Advantage

Infrastructure

Corporate Overview

Peopl e

Quality at Veeda

Clients and Awards

Experien ce

The Veeda Advantage Extensive Scientific Competence to service a Diverse client base

High Customer Centricity and Satisfaction

Skilled personnel with focus on Continuous Professional Development

Independent CRO

Robust Quality & Regulatory Compliance

One stop solution for Complex Studies

CORPORATE OVERVIEW

Evolutio n

Privately owned, board managed company

New Facility at Founded at Shivalik with

First regulatory inspection from

WHO, US FDA & UK MHRA

37 Employees

2004 Ahmedaba d

2006

200 7

First regulatory inspection from

ANVISA

201 0

New Facility at

Mehsana, Total

Vedant

number of Employees 970

2015 2018

201 9

New Facility at

Insignia

ď&#x201A;§ New Facility at

Skylar, Exclusively for Screening

ď&#x201A;§ CX Partners join

Corpor ate Outlook

Focus on Organic and Inorganic growth strategies to enhance service capabilities

Operational Stability based on experienced professional management and strong quality culture

Financial Stability based on prudent management & Private Equity sponsorship

Ongoing investments in technology to enhance operating efficiencies and compliance management

Corporate 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 s

Honesty and Integrity

Excellenc e

Innovation

Nurturing Individual Growth

Quality Structure “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 Policy Quality Manageme nt System Quality Culture

 Comprehensive system with more than 350 SOPs  QC & QA monitoring  Monthly Quality Review Meetings

Balanced Score Cards (BSC) for augmenting corporate strategy Quantifiable Performance Metrics for all departments

Individual KPI’s & KRA’s linked to BSC

 CAPA Management

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

Continuous process improvement

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

months

33*

3 *FDA : 17 AUDITS FOR PATIENT BASED STUDIES 16 AUDITS FOR HEALTHY SUBJECTS

Experienc eBA/BE

1012 Pilot

studies Total 323 2

1632 Pivotal

12 Glucose Clamps studies (700 clamps)

588 Standalone BioAnalytical

19 Inhalation Studies

45 Special Studies *Both Pilot and Pivotal BA/BE

14 FTF Studies

4 Suppositories 10 Patches Studies

88 Complex Clinical Studies

Patient based studies Type of Study Global multi-centred Phase II clinical trials PK Clinical Trials Phase III studies of injectable implants Stand-alone Medical writing BE-PK studies

No. of Studies Complete d Ongoin g Complete d Ongoin g

04 02 22 08 02 04

Therapeutic Segment Oncolog y Oncology and CVS Oncology (14), Psychiatry (6), Rheumatology & Dermatology (1), HIV (1) Oncology (6), Psychiatry (1), Gynaecology (1) Bone disease Psychiatry and oncology

INFRASTRUC TURE

Clinical Infrastructure

VEDANT

SHIVALIK

Clinical, Bioanalytical with administrative offices

Dedicated Clinical facility

MEHSANA

INSIGNIA

Clinical and Screening facility

Dedicated Bioanalytical facility

SKYLAR

ARCHIVES

Common screening facility for both Shivalik and Vedant

Internal archival area in each facility. Separate long term archival facility at Mehsana and Unjha

Spread across 17 clinics Vedant Shivalik

170 Beds + 7 Special care beds 12 Intensively monitored beds to conduct Phase I study

502 Beds +

20Speci al care beds

170 Beds + 6 Special care beds

Mehsana

162 Beds + 7 Special care beds

Bioanalytical Infrastructure  46 LC-MS/MS machines  Insignia - 33  Vedant - 13  API 5500/4000/3200/3000/2000

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

 Shimadzu 8060/8050/8040  Quattro Premier

 2 ICP-OES  Watson LIMS

Archival: Capacity to archive approximately 51000 files

CAPABILITIE S

BA/BE Capabilities

Volunteer Database (More than 53,900)

Male Volunteers

Complex studies: Cotinine free studies

 High number of ambulatory samples  Long Washout periods

FTF studies

>47,00 0

Female Volunteers

>3,800

Elderly Males

>1,600

Post - Menopausal Females

>1,500

Routes of administration

Intensive Safety Monitoring

20 different dosage forms      

Inhalation Transdermal Patches Rectal/Vaginal suppositories Orals Glucose clamps LAIs

Patient Trials capabilities

Clinical End point studies

Therapeutic Expertise

Phase II / Phase III studies

Oncolog y  Chronic myeloid leukaemia (CML)

Psychiatr y  Schizophrenia

 Metastatic Breast Cancer

 Epilepsy

 Non – small cell lung cancer (NSCLC)

 Alzheimer

 Renal cell carcinoma (RCC)  Colorectal Cancer  Small cell lung cancer (SCLC)  Ovarian Cancer

Cardiology, Immunology (HIV), Dermatology, Rheumatology, PK / PD End point studies

Diverse Routes of administration

Gastroenterology, Orthopaedics Ophthalmology, ENT etc • Extensive Investigators network and experienced project management team • eCTD compilation and data management

Bioanalytical Types of Methods Capabilities

Total available Bioanalytical methods are more than 850

731 + 19

Generics + PD/IM

NCE s

2 7

State of the art Comple x



Capability to develop methods with lowest quantification level- up to 0.1 pg



MD/M V

Methods developed for: 

Endogenous molecules



Hormones



Steroids



Inhalation formulation



Elemental Bioanalysis



Immunogenicity



Bioanalytical Salient Features 

Average capacity of 1,00,000 samples per month



Central Bioanalytical Laboratory



Large molecules/ECLIA/ELISA Multiple analysis in single injection



Central labs for Phase II / Phase III studies



Tissue distribution studies

Biopharmaceutics and Project Management Study Designing

Regulator y

Medical Writing

eCTD compilation

PK and stats Data evaluation

Training & Development

Peopl e

12 Continuous Professional Development (CPD) program topics/year/department

Dedicated Training Laboratory with world class features

GCP/GLP training conducted externally once every year SOP training conducted on an ongoing basis

ACLS/BLS training conducted every quarter eModules Training done through iPads

22 S

M BB

71 5

OTHER S

CLIENTS AND AWARDS

Cliente le

Revenue Generation by Client Size

Overall Customer Retention Rate

Mid-Size Clients

>90%

30 %

Small Client s

90% of the revenue

Large size / MNC(s)

36 % 34 %

Clients Active in the Past year

Total Clients

comes fromExisting clients

9 ROW Indi a

U S

142 89 Chin

3 ROW

Indi a

130 54 E U

Chin

1 6

U S

19 E

Achievement s

Organization

Award Category Best Clinical Research Organization - India Clinical Trial Company of the Year Bharat Udhyog Ratan Award in Clinical Research

14 + YE A R S

200 4

201 7 Organization

Award Category

201 8

National Excellence Award

Health & Safety Awards

Best Pharmaceutical CRO Best Clinical ResearchIndia Best Clinical Research- India Mark of Excellence Indian Clinical Research company of the year

201 9 Organization

Award Category Best Quality Clinical Research Organization in India Best Quality Clinical Research Organization in India