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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 & biotechnology companies.
• Known as an Integrated health service provider of choice.
• Deliver sophisticated clinical research services without compromising quality or timelines.
A Promise to Precision in Clinical Trials
Overview
Established in Sept. 2004.
Central Headquarters at Hyderabad, India.
Facilities in 4 Countries (India, US, Mexico and Thailand)
and more than 500+ professionals operating worldwide.
Fully Compliant with ICH GCP, ICMR, Mexican COFEPRIS,
Thai FDA and Schedule – Y Guidelines.
Combined Clinical bed Strength of 570+, supported by 32
LC-MS/MS instruments, with more than 300+ validated
analytical methods.
More than 55,000 active study participants in global
database.
Over 80% business : Repeat business.
Leading Global Clinical Researchorganization accelerating the Drug
Development.
A Promise to Precision in Clinical Trials
Overview…
Experience:
9+ years of Biopharmaceutical experience for Global clients.
70+ Pharma and Biotech Sponsors all over the globe.
1800+ successful clinical studies.
Consistency:
Less than 5% attrition YOY.
More than 80% Repeat Business.
Global Footprints :
Operations : India, USA, Mexico and Thailand.
Offices in India, USA, Mexico and Thailand.
A Promise to Precision in Clinical Trials
Global Regulatory Accreditations - Milestones2015
2014ANVISA-Brazil : MarchWHO : March2013 Thai-GLP : January
USFDA : MarchANVISA-Brazil : June2012 ANVISA – Brazil : August
USFDA : August UK-MHRA : September
ANVISA – Brazil : October.USFDA : October.
US-FDA : February. US-FDA : March.US-FDA : October. ANVISA- Brazil : August. UK-MHRA : October. Turkey-MOH : December.
2011
2010
US-FDA : May.US-FDA : June.
2009UK-MHRA : February.FRENCH-AFSSAPS : June.ANVISA- Brazil : October.US-FDA : October.
US-FDA : March. US-FDA : October.
2008
2007 NABL : January.ANVISA- Brazil : August.
A Promise to Precision in Clinical Trials
Capabilities /
PK / PD studies
Expertise @ AXIS
Clinical Research
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)
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
SelectionSite Monitoring
Site Management
Quality Assurance/Audit Services
A Promise to Precision in Clinical Trials
Capabilities / Expertise @ AXIS
Clinical Data Management
…
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
Data Management Plan
Database Design & Development
Double-Data Entry
Query Management
Medical Coding, SAE Data Reconciliation
Edit, Validation and Design check
programmingData Validation
Data Cleaning
Quality Control and Data Quality Audits
Database Lock and Export to SAS
Clean Data Files
Project Data Archival and Storage
A Promise to Precision in Clinical Trials
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
Credentials
Regulatory Inspections & Approvals
Successfully completed 45+ regulatory audits by Indian and International regulatory bodies
Completed 70+ National and International sponsor audits
Product Approvals
UK MHRA
Brazil ANVISA
US FDAWHOCanada
France AFSSAPS
Turkey MOHSouth Africa Australia
WHO
Thai GLP
Mexico MOH MalaysiaNABL India
A Promise to Precision in Clinical Trials
Bio-studies Experience : Geographical Submissions
France, 6
Turkey, 18Korea,
30Australia, 69
Brazil, 78
Russia, 3India, 3WHO,
15
US, 1153Canada, 124
Europe, 337
Studies Completed = 1836
A Promise to Precision in Clinical Trials
Clinical Pharmacology : India Operations
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 & 3 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
In-House Clinical Reference Laboratory
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).
A Promise to Precision in Clinical Trials
Bioanalytical Lab
18 LC-MS/MS
(SCIEX API 2000, 3000, 3200, 4000, 4000Q and 5000)
5 HPLC-UV/Fluorescent Detectors.
3 ICP-OES for Trace Metal Analysis.
300+ 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.
A Promise to Precision in Clinical Trials
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
molecules
stage for large
Insulin
Glucagon
Enoxaparin
A Promise to Precision in Clinical Trials
Expertise (Formulations & Therapeutic Areas)
Formulations Therapeutic Areas
Oral Solids – Capsules, Tablets,
Softgels, Granules, ODT, ODP,
Modified Release
Liquid Orals
Parenterals
Transdermal patches
Topical Gel
Cream
Inhalers
Nasal Sprays
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
Quality Systems @ AXIS
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
Clinical Research (Phase II –IV)
Phase 2-4 Clinical Trials (New Chemical Entities)
>450 sites
>800 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
Experience – Clinical Trials
A Promise to Precision in Clinical Trials
Sr. No. Segment Study phase Patients / Current statusSites
1. OPHTHAL Phase III 514; 10 sites Recruitment expected to complete in 90 days
2. Gastro Phase III 485; 20 sites Recruitment expected to complete in 180 days
3. CNS Cl PK study 28; 2 sites Recruitment expected to complete in 45 days
4. CVS Cl PK study 32; 2 sites Recruitment expected to complete in 50 days
5. Onco Cl PK PD study 30; 5 sites Recruitment expected to complete in 50 days
6. Onco Cl PK PD study 120; 20 sites Recruitment expected to complete in 60 days
7. CNS Cl PK study 28; 2 sites Recruitment completed within 50 days
8. CNS Cl PK study 40; 3 sites Recruitment completed within 81 days
9. CNS Cl PK study 26; 4 sites Recruitment completed within 79 days
10. CNS Cl PK study 34; 2 sites Recruitment completed within 170 days
11. URO Phase IIa 180; 8 sites Recruitment completed within 120 days
12. CNS Cl PK study 42; 4 sites Recruitment completed within 75 days
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
Support Teams at Axis
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 : Experienced personnel to maintain Quality of the highest
standards.
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
A Promise to Precision in Clinical Trials
Clinical Pharmacology
USA
360 Beds in CPU
1,20,000 sq. ft area (Dilworth, MN) Dedicated
Dermatology Research Center Expertise in
Derma and Controlled substances
World-class infrastructure to support the America
market & other Regulated markets.
25+ LC-MS/MS for bioanalysis.
Independent Project Management Group.
A Promise to Precision in Clinical Trials
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
Clinical Research
Thailand
Capabilities to conduct and monitor the Phase II – IV studies
Tie up with Hospital setup for clinical studies
Site Management
Clinical End Point Studies Patient
Population PK Studies Independent
Project Management Group.
A Promise to Precision in Clinical Trials
The AXIS Edge
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.
A Promise to Precision in Clinical Trials
we
Corporate Headquarter:
1-121/1, Miyapur, Hyderabad 500 049, INDIA
Abhijit Chaudhari
Director-Business Development (India, EU & ROW)
Thank You
A Promise to Precision in Clinical Trials
www.axisclinicals.com