AXIS Clinicals Corporate Presentation

A Promise to Precision in Clinical Trials

Vision / Mission
• To be the preferred, trusted and valued Clinical development partner
for global pharmaceutical & biotechnology companies.
• Known as a Integrated health service provider of choice.
• Deliver sophisticated clinical research services without compromising quality or timelines.

Value Based Leadership : Our mission outlines the value that provides the
foundation to perform as a Global service provider and as individual
employees so that we can continue to put the needs of the Customers we serve first.
Integrity : We do what is right.
a) We are committed to conduct our business with individual and organizational Integrity.
b) We comply with Local and International laws.
c) We are reliable, honest and trustworthy in our dealings.
Responsibility : We hold ourselves accountable for our actions.
a) We take personal responsibility in everything that we do and we lead by example.
b) We treat our Organization's reputation as our own.
c) We are committed to a culture of shared responsibility that promotes high performance.
Our Core Values

a) Speed :
We will speed you to the next milestone, while avoiding the bumps in the road.
Because the faster you reach each milestone, the faster your compound can be
advanced to next stage.
b) Quality :
We are passionate about what we do and want our name to stand for Excellence.
We are determined to be an example that the industry aspires to follow.
c) Customer Focus :
We build long lasting, collaborative relationship with our customers and work with
them as thought partners.
c) Disciplined Timelines :
We value the importance of time and adhere to our commitments.
Your Preferred Partner of Choice – Why ?

Leading Global Clinical Research
organization accelerating the Drug
Development.
 Established in Sept. 2004.
 Central Headquarters at Hyderabad, India.
 Facilities in 3 Countries (India, Mexico and Thailand)
and more than 400+ professionals operating worldwide.
 Fully Compliant with ICH GCP, ICMR, Mexican COFEPRIS,
Thai FDA and Schedule – Y Guidelines.
 Combined Clinical bed Strength of 500 +, supported by 22
LC-MS/MS machines, with more than 275+ validated analytical
methods.
 More than 50,000 active study participants in global
database.
 Over 80% business repeat business.
Overview

Experience:
 8+ years of Biopharmaceutical experience for Global clients.
 50+ Pharma and Biotech Sponsors all over the globe.
 1550+ successful clinical studies.
Consistency:
 Less than 5% attrition YOY.
 More than 80% Repeat Business.
Global Footprints :
 Operations : India, Mexico and Thailand.
 Offices in India, USA, Mexico and Thailand.
Overview…

2007
2008
2009
2010
2011
2013
ANVISA- Brazil : ANVISA Certification.
US-FDA : October.
US-FDA : March.
UK-MHRA : February.
FRENCH-AFSSAPS : June.
ANVISA- Brazil : October.
US-FDA : October.
US-FDA : May.
US-FDA : June.
US-FDA : February.
US-FDA : March.
US-FDA : October.
Turkey-MOH : December.
ANVISA- Brazil : August.
UK-MHRA : October.
ANVISA – Brazil : August
USFDA : August
Global Regulatory Accreditations - Milestones
NABL : Accreditation.
ANVISA – Brazil : October.
USFDA : October.
2012

Capabilities / Expertise @ AXIS
PK / PD studies
 Bioequivalence / Bioavailability studies
 Pharmacokinetic / Pharmacodynamic
studies in Healthy subjects
 Special / Patient Population studies.
 Food effect / Drug – Drug Interaction
studies.
 Proof of Concept studies.
 End-to End Service
 - Protocol to Report
 Project Management
 Final submission Report (eCTD / ICH E3)
Clinical Research
 Phase II- IV trials
 PK / PD Studies in patients
 Feasibility Studies
 Project Planning and Setup
 Study Design and Protocol Writing
 Regulatory Approvals
 Design & Development of CRF / eCRF
 Site/Investigator Identification and
Selection
 Site Monitoring
 Site Management
 Quality Assurance/Audit Services

Biostatistics & Medical Writing
 Sample Size and Power Calculation
 Medical writing and literature search
 Providing Statistical Inputs during
Protocol Designing
 Randomization
 Statistical Analysis Plan (SAP)
 SAS Programming and Validation
 Interim Analysis
 Statistical Report
Clinical Data Management
 Data Management Plan
 Database Design & Development
 Double-Data Entry
 Query Management
 Medical Coding, SAE Data Reconciliation
 Edit, Validation and Design check
programming
 Data Validation
 Data Cleaning
 Quality Control and Data Quality Audits
 Database Lock and Export to SAS
 Clean Data Files
 Project Data Archival and Storage
Capabilities / Expertise @ AXIS …

Capabilities / Expertise @ AXIS …
Stand Alone Services
 Regulatory Services.
 Central Reference Lab Services.
 Bio Analytical Services.
 Metal Ion analysis.
 Biostatistical & Medical Writing.
 Quality Assurance.
 Clinical Data Management.

Regulatory Inspections & Approvals
 Successfully completed over 38 regulatory audits by Indian and International regulatory bodies
 Completed 50+ National and International sponsor audits
Canada
Turkey MOH
Credentials
WHO
Australia
US FDA
UK MHRA
Brazil ANVISA
France AFSSAPS
Mexico MOHNABL India
South Africa
Product Approvals
Malaysia

US, 973
Europe, 300
Brazil, 67
Canada, 101
Australia, 62
Korea, 25
WHO, 10
Turkey, 12
Russia, 3
India, 3
Studies Completed = 1550+
Bio-studies Experience : Geographical Submissions

Clinical Pharmacology
India
 292 Beds arranged in 7 study areas in 2 locations .
 1,90,000 sq. ft area.
 7 Intensive Care Units with cardiac monitoring.
 Audited &/or accredited by US FDA, UK MHRA, Brazilian
ANVISA, India (DCGI), AFSSAPS, NABL and ISO 9001:2000.
 World-class infrastructure to support clinical activities.
 18 LC-MS/MS & 1 ICP-OES for bioanalysis.
 Capacity to handle approx. 2000 Clinical dosings / month.
 Capability to analyze approx. 35,000 samples / month.

Mexico
 100 Beds arranged in 3 study areas.
 Intensive Care Units with cardiac monitoring.
 Dedicated Clinical Reference Lab.
 Approved by Cofepris (Mexican Regulatory
Agency) for Clinical and Bioanalytical operations.
 World-class infrastructure to support the Latin
America market & other Regulated markets.
 4 LC-MS/MS for bioanalysis.
 Independent Project Management Group.

Thailand
 72 Beds arranged in 6 study areas.
 Hospital setup
 Intensive Care Units with cardiac monitoring.
 World-class infrastructure to support clinical activities in SE
Asian countries.
 Capabilities to conduct and monitor the Phase II – IV studies

 Testing @ ACRL
 Hematology and Coagulation Assays
 Biochemistry
 Clinical Pathology
 Immunoassays
 Histopathology
 NABL (National Accreditation Board for Testing and
Calibration Laboratories) accredited laboratory
 Audited by Brazil ANVISA & UK MHRA
 Services for Clinical Trials having multiple sites & CROs
(Stand Alone Services also offered).
Clinical Reference Laboratory

 18 LC-MS/MS
(SCIEX API 2000, 3000, 3200, 4000, 4000Q and 5000)
 5 HPLC-UV/Fluorescent Detectors.
 1 ICP-OES for Trace Metal Analysis.
 275+ validated assays.
 Quantitative analysis of parent drugs and their
metabolites in a variety of biological matrices.
 Networked Chromatographic Data Management
(Scientific Data Management System)
 Solid Phase Extraction Systems.
 Nitrogen Evaporators.
 Capability to analyse > 35,000 samples/month.
Bioanalytical Lab

 Critical assays developed First-in-Asia for small molecules
 Conjugated Estrogen
 Esterified Estrogens
 Estradiol
 Ethinyl Estradiol & Levonorgestrol
 Many combinations of Oral Contraceptives
 First-in-world assays for small & large molecules
 Loteprednol in Aqueous Humor
 Dexamethasone in Aqueous Humor
 Testosterone in serum
 Critical assay in development and validation stage for large
molecules
 Insulin
 Glucagon
 Enoxaparin
Bioanalytical Lab …

Expertise (Formulations & Therapeutic Areas)
Formulations
 Oral Solids – Capsules, Tablets,
Softgels, Granules, ODT, ODP,
Modified Release
 Liquid Orals
 Parenterals
 Transdermal patches
 Topical Gel
 Cream
 Inhalers
 Nasal Sprays
Therapeutic Areas
 Antibiotic/ Antimicrobial
 Antidepressant
 Antiepileptic
 Antiretroviral
 Hormone
 Hypoglycemic agents
 Lipid lowering agents
 Muscle relaxants
 NSAIDs
 Narcotics
 Oral contraceptive
 Psychotropic agents

Quality Systems @ AXIS
 A 30 member dedicated team reporting to QA Head.
 Quality Control (QC) Procedures in place apart from Quality Assurance (QA) Procedures.
 All activities are subjected to rigorous review for Quality Assurance including
 Clinical (over 50 SOP’s)
 Bio-analytical
 PK / Stats / Reporting
 Internal Audits by QA team for Area Specific SOP compliance.
 In-house capabilities to perform Site Audits, Systems / Process Audit, Vendor Audit.
 Document Audits (Protocol, Clinical Study Report & essential Clinical Trial documents).
 All QA systems are compliant with all applicable local & international regulations.

Clinical Experience and Capabilities
 Summary Protocol / Synopsis
 Study Feasibility Analysis
 Study Design
 Medical Writing and Protocol Development
 Project Planning and Setup
 Regulatory Approvals
 Design & Development of CRF / eCRF
 Site/Investigator Identification and Selection
 Site Management
 Site Monitoring
 Clinical Data Management
 Clinical Study Reports
 Quality Assurance / Audit Services

Clinical Research (Phase II –IV)
 Phase 2-4 Clinical Trials (New Chemical Entities)
 >150 sites
 >200 Investigators
 Oncology, CNS, Cardiology, Gastrointestinal, Orthopedic,
Ophthalmology, Endocrinology & Metabolism
 505(b)(2) Clinical Studies.
 Clinical End Point Studies.
 Patient Population PK Studies,

Experience – Clinical Trials
Sr.
No.
Therapeutic
Segment
Study phase Patients /
Sites
Current status
1. Allergic
conjunctivitis
Phase III 514; 10 sites Recruitment expected to
complete in 90 days
2. Schizophrenia Clinical PK
study
28; 2 sites Recruitment completed within 50
days
study
days
study
days
5. Epilepsy Clinical PK
study
34; 2 sites Recruitment completed within
170 days
6. Anemia in CKD Phase IIa 180; 8 sites Recruitment completed within
120 days
study
days

CNS
13%
Oncology
21%
Gastroenetrology
5%
Dermatology
8%
Cardiology
11%
Urology
5%
Ophthalmology
32%
Respiratory
5%
Study Pipeline

AXIS’ Investigator & Sites relationship
Clinical Research – Potential Investigator Database

Clinical Data Management & Biostatistics
 Oracle Clinical® v4.6 with Remote Data Capture
 Project Specific Clinical Data Management Plan
 Customized Database Design & Development
 Independent Double-Data Entry
 Query Management
 Medical Coding, SAE Data Reconciliation
 Edit, Validation and Design check
 Data Validation
 Data Cleaning
 Quality Control and Data Quality Audits
 Database Lock and Export to SAS
 Documentation CDM Report

 Project Management Group (PMG) : Dedicated Project Managers are assigned to each
Client to ensure the timely execution of the projects at AXIS Clinicals. Back up
Project Managers help to maintain the continuity.
 QA Department : 30 experienced personnel to maintain Quality of the highest
standards.
 HR / Training Department: A team of 4 people in the Training Department ensures the
Inductions, On Job Trainings, Refresher Trainings and arranging External
Trainings for the AXIS employees.
 Validation : AXIS has a dedicated team for Validation and the maintenance of
Scientific equipment is done on a regular basis by the GLP Engineers.
 Pharmacy : Each of the Clinical Units of AXIS has Dedicated Pharmacists for the
IMP Management
Support Teams at Axis

Management Team
Michael Padvaiskas Ackerman
President - Mexico Operations
Dr. A. Jayachandra Reddy
Sr. V.P – Clinical Pharmacology
Dr. Yati Chugh
Chief Executive Officer
B. Phani Bhushana Reddy
Sr. V.P – Bioanalytical Operations

Someswar Korla
Head – PK/Stats/Medical Writing
Sathish Munaga
Head – Quality Assurance
Abhijit Chaudhari
Director – Business Dev. (India / ROW)
Sidharth Mishra
Director – Business Dev. (U.S.A)
Dr. Subhra Lahiri
AVP – Clinical Research
Dr. Kshitij Soni
Director – ASEAN Operations

 End to End service provider with experienced Clinical research professionals and Excellent
infrastructure.
 Impressive Accreditations from International Regulatory Bodies.
 Successful Regulatory Inspections track record.
 Teams with Rich professional Experience.
 Expertise in various Therapeutic segment.
 Access to Patient’s in major therapeutic areas.
 Fast and excellent Turn around time.
 Competitive Pricing as compared to Industry Peers.
 AXIS can help you to file FTF application in 18 – 20 days.
 Top 5 International Generic companies among the list of Client’s.
The AXIS Edge

Thank You
Corporate Headquarter:
1-121/1, Miyapur, Hyderabad 500 049 INDIA
Dr. Yati Chugh
Chief Executive Officer
yati.c@axisclinicals.com
Abhijit Chaudhari
Director-Business Development
abhijit.chaudhari@axisclinicals.com
Sidharth Mishra
Director-Business Development (U.S.)
sidharth.m@axisclinicals.com

AXIS Clinicals Corporate Presentation

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