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 an Integrated health service provider of choice. • Deliver sophisticated clinical research services without compromising quality or timelines.



Leading Global Clinical Research organization accelerating the Drug

Development.

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.

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.

Overview…

2007

2008

2009

2010

2011

2013

NABL : January. ANVISA- Brazil : August.

US-FDA : March. US-FDA : October.

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. ANVISA- Brazil : August. UK-MHRA : October. Turkey-MOH : December.

ANVISA – Brazil : August USFDA : August

Global Regulatory Accreditations - Milestones


ANVISA – Brazil : October. USFDA : October.

2012

2014

Thai-GLP : January USFDA : March ANVISA-Brazil : June UK-MHRA : September

2015

ANVISA-Brazil : March WHO : March

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


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 45+ regulatory audits by Indian and International regulatory bodies

Completed 70+ National and International sponsor audits

Canada

Turkey MOH

Credentials

WHO

Australia

US FDA

UK MHRA

Brazil ANVISA

France AFSSAPS

Mexico MOH

NABL India

South Africa

Product Approvals


Malaysia

Thai GLP

WHO

US, 1153

Europe, 337

Canada, 124

Brazil, 78Australia, 69

Korea, 30Turkey, 18

WHO, 15

France, 6

Russia, 3

India, 3

Studies Completed = 1836

Bio-studies Experience : Geographical Submissions


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.


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).

In-House Clinical Reference Laboratory


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.

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

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 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,


Experience – Clinical Trials Sr. No. Segment Study phase Patients /

Sites Current status

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




11. URO Phase IIa 180; 8 sites Recruitment completed within 120 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


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

Support Teams at Axis


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.


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.



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



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

Abhijit Chaudhari

Director-Business Development (India, EU & ROW)

[email protected]


axis clinicals corporate presentation

Documents

clinical trials anvisa

successful clinical

clinical trials experience

anvisa brazil

clinical development

clinical trials vision

thai fda

trials pk pd studies