2. 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.
A Promise to Precision in Clinical Trials
3. A Promise to Precision in Clinical Trials
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
4. A Promise to Precision in Clinical Trials
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 ?
5. A Promise to Precision in Clinical Trials
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
6. A Promise to Precision in Clinical Trials
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…
7. 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
A Promise to Precision in Clinical Trials
NABL : Accreditation.
ANVISA – Brazil : October.
USFDA : October.
2012
8. 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
Project Management
Site/Investigator Identification and
Selection
Site Monitoring
Site Management
Quality Assurance/Audit Services
A Promise to Precision in Clinical Trials
9. 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 …
A Promise to Precision in Clinical Trials
10. 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.
A Promise to Precision in Clinical Trials
11. 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
A Promise to Precision in Clinical Trials
Malaysia
12. 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
A Promise to Precision in Clinical Trials
13. 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.
A Promise to Precision in Clinical Trials
14. Clinical Pharmacology
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.
A Promise to Precision in Clinical Trials
15. Clinical Pharmacology
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
A Promise to Precision in Clinical Trials
16. 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
A Promise to Precision in Clinical Trials
17. 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
A Promise to Precision in Clinical Trials
18. 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 …
A Promise to Precision in Clinical Trials
20. 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.
A Promise to Precision in Clinical Trials
21. 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
Project Management
Clinical Data Management
Clinical Study Reports
Quality Assurance / Audit Services
A Promise to Precision in Clinical Trials
22. 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,
A Promise to Precision in Clinical Trials
23. 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
3. Schizophrenia Clinical PK
study
40; 3 sites Recruitment completed within 81
days
4. Schizophrenia Clinical PK
study
26; 4 sites Recruitment completed within 79
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
7. Schizophrenia Clinical PK
study
42; 4 sites Recruitment completed within 75
days
A Promise to Precision in Clinical Trials
25. AXIS’ Investigator & Sites relationship
Clinical Research – Potential Investigator Database
A Promise to Precision in Clinical Trials
26. 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
A Promise to Precision in Clinical Trials
27. 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
A Promise to Precision in Clinical Trials
28. 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
A Promise to Precision in Clinical Trials
29. 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
A Promise to Precision in Clinical Trials
Dr. Kshitij Soni
Director – ASEAN Operations
30. 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
A Promise to Precision in Clinical Trials
31. 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
A Promise to Precision in Clinical Trials