Clinart MENA Profile 2014

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Date: 01 April 2014 Version_06_April 2014

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•  A TRUE Leader for clinical research in the MENA region

•  12 years of regional presence and developing capabilities

•  Largest footprint in the region with direct access to all key markets

•  Success-‐driven leadership, with commitment to quality

•  Track record of local, regional, and international clinical trials

•  Professional expertise across a full range of services

•  Supportive board and investors for growth and expansion

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Clinart MENA – Who We Are

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Regional Footprint: -‐ Direct Access to 10 Countries -‐ Qualified Partners in 4 other

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Clinart Local Offices Clinart CRAs Clinart Qualified Partners

Iran

Pakistan

Saudi

Lebanon

Yemen

Dubai: Head quarter since 2001 (as MECRO); covers Kuwait, Bahrain, Oman, Qatar Saudi: local branch office since 2008; SFDA approved in 2012 Tunisia: local office expected Q2 2014 Egypt: local representative office since 2008 Lebanon: local branch office since 2012; covers Jordan


2001

Middle East Clinical Research Organisation (MECRO) established in Dubai, UAE

2005

MECRO Merged with Clinart International at Dubai Health Care City, Dubai UAE; Clinart offices established in Saudi and Egypt

2008

Alliance agreement with ACRP; Business partnership agreement with Oracle Health

2009

Awarded Oracle Gold Partner Certificate; ISO 9001 – 2008 certified

2010

Establishment of the Gulf Chapter for the Association of Clinical Research Professionals

Clinart MENA is the first local CRO to receive growth capital from an investment group (KLSC)

2011

History: 12 years of MENA Experience

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Alaa Assem, MD , MBA President & CEO Clinart MENA Maha Al-‐Farhan, Founder and Board Member Clinart MENA

Board Members: Visionary leadership and regional expertise

Qais Marafie Chairman and CEO Kuwait Life Science Company Mohammad Al Anzi, Chief Operating Officer Kuwait Life Science Company


Senior Management: Average 15 years of industry experience, bringing global standards to the local environment

Alaa Assem, MD, MBA President and CEO

-‐ 20 years of experience working in regional roles and capacities including: medical affairs, clinical research, regulatory, compliance and government affairs -‐ Appointments included several multinational organizations, such as Lilly, Wyeth, Pfizer Mohamad Muzamil Jehanzieb, PMP Manager-‐ CDM

-‐ PMP certified professional with 11 years of work experience -‐ Expertise in Clinical Data Management, Pharmacovigilance, Business Development, Consulting, Training & Development, with hands-‐on experiecne on Oracle clinical and RDC -‐ He has lead and managed project for some of the MNC like Pfizer, GSK, Merck, Diagnosearch, Strides -‐ a Mylan company, etc. in his previous engagements Hesham Shaddad Finance Director

-‐ 15 years of financial management experience -‐ Certified Management Accountant, Certified Internal Audit and Certified Treasury Professional -‐ Prior to joining Clinart, Hesham several positions Worked in as a Finance Manager / Finance Controller in Egypt and UAE for leading Telecommunication companies in the region.

Shada Sayegh, PharmD, Msc. Head of Clinical Operations

-‐  Over 10 years of experience in clinical operations, including project management and monitoring

-‐  Worked with J&J for 4 years prior to joining Clinart MENA -‐  Received project management award from ACRP in 2012 Ola El Kadi, MSc. Quality and Training Manager

-‐ Over 15 years of experience in Quality and clinical operation roles -‐ Appointments included KENDLE and Gamma-‐Dynacare in Canada, GRC in Egypt, prior to joining Clinart MENA

Mira Serhal, MPH Business Development Director

-‐  8 years of industry experience across regional CROs

Mohsin Sheikh IT Project Manager -‐ 12 years of experience in the field of IT starting from software engineer to Senior System Analyst.


Senior Management Average experience: 12 years

MS or PharmD degrees Average experience: 3+ years

BS or PharmD degrees Average experience: 2-‐3 years

Average experience: 2+ years

Organization Chart: -‐ Core team of 30 FTEs from 8 different nationalities -‐ Access to 20 additional non-‐ FTEs across the MENA

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Board of Directors

CEO

Data Management

-‐ Data Manager -‐ Biostatistics

-‐ Medical Writer

Data Entry TEAM

Clinical Operations

CRM/ Project Managers

(Senior) CRA

CTA

Business Development

Marketing Associate

Training & Quality

Quality Associate

IT

IT Support

Finance / HR

Admin – Accounting support


Global and Regional sponsors /service providers have partnered with Clinart MENA for their different CT needs:

Clinical Operations

Data Management

Medical Writing

Regulatory Support

Quality and Training

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A recognized partner for: Ø  7 out of top 10 Pharma Ø  Midsize pharma Ø  Biotechnology Ø  Nutraceutical Companies Ø  Medical device Companies Ø  Qualified Regional specialist supporting global CROs


Services -‐  Study feasibility and site selection -‐  Study startup and regulatory submissions -‐  Study Management and Monitoring -‐  Study drug logistics (import)

Early Phase Experience –  12 Protocols implemented –  Total of 1,221 patients recruited –  49 active sites as of 2013 across

Late Phase Experience –  46 Protocols implemented –  Total of 9,382 patients recruited –  140 active sites as of 2013

Clinical Operations Record: 1. Local Expertise at Global Standards

Clinical Operations

Data Management

Medical Writing

Regulatory Support


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Diverse Therapeutic Expertise

25%

13%

11% 11%

9%

4%

4% 3% 3%

3% 3% 1%

Endocrinology CVD Oncology

Pain Management Neurology Rheumatology

Hematology Medical Device Dermatology

Hepatology Gastroenterology Rase Disease

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Clinical Operations Record: 2. Phase II and III Experience

Clinical Operations

Data Management

Medical Writing

Regulatory Support


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470

53

688

Phase II Phase III

Over 1,200 patients enrolled to-‐date

Ongoing Completed

1 1 1

2 1

2 1

1

1

4

4

4

1 0

1

2

3

4

5

6

7

8

9

2013: 28 sites across 8 countries

Neurology

Rare Disease

Hematology

Vaccine

Oncology


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Clinical Operations Record: 2. Phase IV and PMOS Experience

Clinical Operations

Data Management

Medical Writing

Regulatory Support


2 1 2

2

1

8

7

2

1

100

6 4

3

0

5

10

15

20

25

2013: 120 Active sites across 8 countries

IBS

Infectious Disease

Endocrinology

Oncology

Analgesic

CVD

Vaccine

Rheumatology

Dermatology

1571

300

3159

4352

Phase IV Epidemiology

Over 9,000 patients enrolled

Ongoing Completed


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Our Advantages Your Benefits Direct, local CRA presence across 10 MENA countries Investigator database of 300+ qualified researchers across different therapeutic areas Extensive relations with active medical associations, institutions and regulators Intelligent focus on MENA disease areas (CVD, Diabetes, rare diseases, Hepatitis, hematology, oncology…..)

Enhanced coverage, quality, performance, and management Optimal selection of sites that meet patient enrolment and retention Constant awareness of changes, updates, and ways to overcome challenges Educated decisions in terms of country and site selection

Clinical Operations

Data Management

Medical Writing

Regulatory Support


Clinical Operations Record: 3. Solutions with proven efficiency, time after time


Services: –  Full scope: from CRF design to medical writing –  FDA (21part11) Compliant system

ü  Oracle Clinical ü  Oracle Clinical Remote Data Capture

Experience: –  Data from 73 studies processed

ü  50 completed study data processing and CSR production ü  23 Ongoing studies ü  Total of 1,049,561 CRF pages processed

Partners:

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Clinical Operations

Data Management

Medical Writing

Regulatory Support


Data Management Record: Over One Million CRF Pages Processed


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7

7

3

1

4

3

4

3

2

1

2

1

1

1

1

1

1

1

1 1

1

1

1

1

1

Protocols

CRFs

ICFs

CSRs

Manuscripts Oncology

Rheumatology

Cardiovascular

Hematology

Nutrition

Pain Management

Infertility

Neurology

Endocrinology

Clinical Operations

Data Management

Medical Writing

Regulatory Support


Medical Writing Record: Over 50 Documents completed so far


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Services: –  Clinical Trial Applications –  Safety reporting –  IMP logistics (import and export licenses) –  Central lab logistics

Experience and Competencies: –  Local expertise with regulatory procedures of each country –  Strong network with key regulators of clinical trials –  Extensive up-‐to-‐date knowledge of regulations –  Constant mapping of regulatory procedures and updates –  Understanding of challenges and expertise in handling delays

Regulatory Support: 1. Strong regulatory capabilities

Clinical Operations

Data Management

Medical Writing

Regulatory Support



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Clinical Operations

Data Management

Medical Writing

Regulatory Support


Regulatory Support: 2. Bringing your studies to initiation within attractive timelines

2 2 2.5 2.5

3 3 3.5 3.5

6.5 7

0

1

2

3

4

5

6

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Bahrain Lebanon Oman Qatar Kuwait Saudi - PMS

Egypt Jordan UAE Saudi- IND

Regulatory Approval

EC Approval

Total Approval Timelines


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Training Experience: Ø  Annual Training programs Ø  Network of renowned, certified trainers Ø  Reputed, high quality training programs Training Services: Standard and tailored training programs in a wide range of topics:

-‐ ICH-‐ GCP -‐ Pharmacovigilance -‐ Medical Writing -‐ Project Management -‐ Advanced Monitoring -‐ Biostatistics

Clinical Operations

Data Management

Medical Writing

Regulatory Support


Quality and Training Capabilities: Dedicated performance

Quality Track Record: Ø  ISO 9001:2008 certified quality system since 2010 Ø  Successful sponsor audits over 12 years Ø  Successful site audits across all MENA


•  Main causes of death: Cancer, Cardiovascular and Diabetes

•  More than 850 genetic diseases

•  High obesity prevalence: 4 of the GCC countries rank in top 20 (more than 25% of the population)

•  Diabetes: Highest region in the world (15-‐20% of the population aged 20-‐60 with Type 2 Diabetes)

•  Hepatitis C: 14% of the MENA population, highest in Egypt

•  Malignancy: 60-‐216/100,000 population

The MENA Advantage:

•  Access to large patient pools, fast recruitment

•  World-‐renowned medical expertise and research centers

•  Developing CT regulatory framework across the region

•  Cost efficiency

•  English language proficiency; one local language across all Arab nations

•  Improving technology and business infrastructure

•  Growing business – attractive markets

Attractive Clinical Trial Environment Highly Prevalent Diseases


The Clinart Advantage:

Qualified Staff

Local Knowledge

Quality and Experience

Confirmed Success


Contact: Mira Serhal, BD Director 00 961 3 792 865 [email protected]


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Clinart MENA Profile 2014

Health & Medicine

Transcript of Clinart MENA Profile 2014