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A Promise to Precision in Clinical Trials
Vision / Mission
• To be the preferred, trusted and valued Clinical development partner
for global pharmaceutical & biotec...
A Promise to Precision in Clinical Trials
Value Based Leadership : Our mission outlines the value that provides the
founda...
A Promise to Precision in Clinical Trials
a) Speed :
We will speed you to the next milestone, while avoiding the bumps in ...
A Promise to Precision in Clinical Trials
Leading Global Clinical Research
organization accelerating the Drug
Development....
A Promise to Precision in Clinical Trials
Experience:
 8+ years of Biopharmaceutical experience for Global clients.
 50+...
2007
2008
2009
2010
2011
2013
ANVISA- Brazil : ANVISA Certification.
US-FDA : October.
US-FDA : March.
UK-MHRA : February....
Capabilities / Expertise @ AXIS
PK / PD studies
 Bioequivalence / Bioavailability studies
 Pharmacokinetic / Pharmacodyn...
Biostatistics & Medical Writing
 Sample Size and Power Calculation
 Medical writing and literature search
 Providing St...
Capabilities / Expertise @ AXIS …
Stand Alone Services
 Regulatory Services.
 Central Reference Lab Services.
 Bio Anal...
Regulatory Inspections & Approvals
 Successfully completed over 38 regulatory audits by Indian and International regulato...
US, 973
Europe, 300
Brazil, 67
Canada, 101
Australia, 62
Korea, 25
WHO, 10
Turkey, 12
Russia, 3
India, 3
Studies Completed...
Clinical Pharmacology
India
 292 Beds arranged in 7 study areas in 2 locations .
 1,90,000 sq. ft area.
 7 Intensive Ca...
Clinical Pharmacology
Mexico
 100 Beds arranged in 3 study areas.
 Intensive Care Units with cardiac monitoring.
 Dedic...
Clinical Pharmacology
Thailand
 72 Beds arranged in 6 study areas.
 Hospital setup
 Intensive Care Units with cardiac m...
 Testing @ ACRL
 Hematology and Coagulation Assays
 Biochemistry
 Clinical Pathology
 Immunoassays
 Histopathology
...
 18 LC-MS/MS
(SCIEX API 2000, 3000, 3200, 4000, 4000Q and 5000)
 5 HPLC-UV/Fluorescent Detectors.
 1 ICP-OES for Trace ...
 Critical assays developed First-in-Asia for small molecules
 Conjugated Estrogen
 Esterified Estrogens
 Estradiol
 E...
Expertise (Formulations & Therapeutic Areas)
Formulations
 Oral Solids – Capsules, Tablets,
Softgels, Granules, ODT, ODP,...
Quality Systems @ AXIS
 A 30 member dedicated team reporting to QA Head.
 Quality Control (QC) Procedures in place apart...
Clinical Experience and Capabilities
 Summary Protocol / Synopsis
 Study Feasibility Analysis
 Study Design
 Medical W...
Clinical Research (Phase II –IV)
 Phase 2-4 Clinical Trials (New Chemical Entities)
 >150 sites
 >200 Investigators
 O...
Experience – Clinical Trials
Sr.
No.
Therapeutic
Segment
Study phase Patients /
Sites
Current status
1. Allergic
conjuncti...
CNS
13%
Oncology
21%
Gastroenetrology
5%
Dermatology
8%
Cardiology
11%
Urology
5%
Ophthalmology
32%
Respiratory
5%
Study P...
AXIS’ Investigator & Sites relationship
Clinical Research – Potential Investigator Database
A Promise to Precision in Clin...
Clinical Data Management & Biostatistics
 Oracle Clinical® v4.6 with Remote Data Capture
 Project Specific Clinical Data...
 Project Management Group (PMG) : Dedicated Project Managers are assigned to each
Client to ensure the timely execution o...
Management Team
Michael Padvaiskas Ackerman
President - Mexico Operations
Dr. A. Jayachandra Reddy
Sr. V.P – Clinical Phar...
Someswar Korla
Head – PK/Stats/Medical Writing
Sathish Munaga
Head – Quality Assurance
Abhijit Chaudhari
Director – Busine...
 End to End service provider with experienced Clinical research professionals and Excellent
infrastructure.
 Impressive ...
Thank You
Corporate Headquarter:
1-121/1, Miyapur, Hyderabad 500 049 INDIA
Dr. Yati Chugh
Chief Executive Officer
yati.c@a...
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AXIS Clinicals Corporate Presentation

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AXIS Clinicals, a privately-owned well established full-service CRO (Contract Research Organization) headquartered in Hyderabad, India

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AXIS Clinicals Corporate Presentation

  1. 1. A Promise to Precision in Clinical Trials
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  19. 19. 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 A Promise to Precision in Clinical Trials
  20. 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. 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. 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. 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
  24. 24. CNS 13% Oncology 21% Gastroenetrology 5% Dermatology 8% Cardiology 11% Urology 5% Ophthalmology 32% Respiratory 5% Study Pipeline A Promise to Precision in Clinical Trials
  25. 25. AXIS’ Investigator & Sites relationship Clinical Research – Potential Investigator Database A Promise to Precision in Clinical Trials
  26. 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. 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. 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. 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. 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. 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

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