Qed India credential presentation

qed-clinical.com [email protected] +44 (0)1908 251 4801

QED Credentials

November 2012


Agenda

Partnering Excellence

� QED – Powerful Partnership

� Global and Local

� Capacity by Region and Coordination

� QED – Quality, Efficiency, Delivery

� QED Global Study Experience

� Project Management Expertise

QED India

� QED India – The Asia Pacific Hub

� QED India Engagement in Nine Months

� QED India - Services

� QED India Staff Experience

� Why QED India?

The QED Difference

OrphanReach


Partnering Excellence


QED: Powerful Partnership

Established in 2002 having 10 years of global partnering experience

Operational Senior Management with more than 26 years experience in clinical research

Over 1,100 clinical experts world-wide

— More than 120 experienced Project Managers

— Over 450 locally based CRAs

Successful delivery of more than 2,700 studies across most therapeutic areas

Proven Specialist Partnering model with focus on customer service


Global & Local

Global

Capacity

Local

Knowledge

Patient

Access &

Retention

Regulatory

Insight


United States and Canada

South AmericaArgentina

Brazil

Chile

Mexico

Bolivia

Western Europe (WEU)

UK

Belgium

France

Germany

Austria

Switzerland

Italy

Netherlands

Portugal

Spain

Russia

Central and Eastern Europe (CEE)

Belarus

Bulgaria

Croatia and Slovenia

Czech Republic

Slovakia

Hungary

Macedonia

Poland

Romania

Serbia and Montenegro

Slovenia

Turkey

Greece

Ukraine

The Baltics

Estonia

Latvia

Lithuania

Nordic / Scandinavia

Denmark

Finland

Sweden

Norway

Africa and Middle East

Egypt

Israel

Lebanon

Macedonia

South Africa

United Arab Emirates

Qatar

Bahrain

Oman

Kuwait

Jordan

Iran

Asia

India

China

Vietnam

Sri Lanka

Bangladesh

Philippines

Japan

Taiwan

Australia

Malaysia

New Zealand

South Korea

Singapore

Thailand

Capacity by Region


Regional Coordination

On-going/ previous Start-up phase

QED European

Hub

QED Asia

Pacific Hub

QED North

American

Hub


Partnering Transformation

The CRO has truly come of age as a real partner and all eyes are on the critical question of

delivery of promises on time and on budget….

The goals for paterning have not changed but the way of delivering must evolve.....

Delivery


QED: Quality


Meeting Quality Standards

• Success is dependent on delivering project goals on time and budget, with an outstanding

attention to quality

• The QED solution is based on attention to standardization, project management, data quality and

regulatory insight that has been field tested and proven to work

• Whether you need 20 patients or 500 patients the same attention to detail will offer the

confidence that you will meet timelines with high quality


QED Quality Management System

Dedicated, Highly Experienced QA Team

Robust Quality Policy

Comprehensive Audit Program and Schedule (external and internal)

Study Specific Guidelines/Manuals

Operations Manual

Induction, function specific, GCP and regulatory, Co-monitoring and Continued Professional

Development

IT- security, back-up, restoration

Disaster Recovery Plan


Delivering Quality………

Local Expertise

and In-depth

Experience

Processes

and Tools

Operational

Excellence

Across the entire Study/Program


Processes/Tools

Error Prevention Plan (EPP)

Lessons learnt sessions for early identification of trends

Quality Indicators Dashboard (QID)

Query trend review & corrective actions

Site issues resolutions/escalations

Recruitment acceleration

Quality Delivery Model

Site Set-up and Rapid Start-up

Dependable investigational sites

Site Assessment Visits

Rigorous training for QED/site staff

Visible management supervision

Effective start-up planning

High Quality

Data


QED: Efficiency


The QED Efficiency Model

Selective, coordinated and managed access to patients in countries without the cost of

infrastructure to achieve your study enrolment

Confidence from experienced project management, performance underwritten by process and

system optimisation and proof of delivery

Flexibility to complement your effort where your study has challenges and bring in immediate

local experience without having to internally coordinate local markets

Manage the peaks and troughs of the outsourced pipeline without maintaining a bench of

expensive underutilised internal resources that deflate and erode margin

Deliver the promise on time and on budget with quality that seamlessly integrates with your

study plan


QED: Delivery


Meeting Your Delivery Needs

Study delivery imperatives

— Understanding feasibility – enhanced through on the ground real life experience

— Understanding project management – coordinating and leading resources to action

— Understanding quality hurdles – regulatory knowledge, data quality, timeliness

Relationship delivery imperatives

— Understanding our sponsors

— Established communication and oversight process

— Lean and efficient model with access to senior management

— Credibility and confidence through established KPI and KRI metrics


QED: The Power of Partners

The heart of delivery is the ability to find and recruit the right patients and this requires

geographic scope and therapeutic experience….

28 established QED partners providing global coverage

Resource on the ground in over 50 countries

12 years average operational history

5 years average partner experience with QED


QED Study Experience

Phase Total # Studies Completed *

I (including BA/BE) 296

II 371

II/III 707

III 998

IV 254

Observational /Registry 121

*Data from last 5 years


QED Therapeutic Experience

Therapeutic Area

Total #

Studies

Completed *

Oncology 356

Haematology 121

Cardiology / Cardiovascular 223

Infectious Diseases 168

Immunology 63

Endocrinology /Metabolic

Disorders222

CNS (Neurology &

Psychology)265 & 157

Urology 139

Therapeutic Area

Total #

Studies

Completed*

Respiratory (incl. Allergy) 207

Gynaecology / Women’s

Health

121

Gastroenterology 158

Rheumatology 162

Dermatology 111

Pain 86

Vaccines 128

Ophthalmology 64

*Data from last 5 years


QED Team Operational Experience


Project Management Expertise

More than 120 Project Managers globally

Average of over 6 years experience in study management

Mean of 14 years in clinical research

Pharmaceutical and CRO background

Multi-discipline including Medics, Registered Nurses, Pharmacists, Scientists

Total accountability for project delivery

Primary point of contact - communication


QED India


QED India – The Asia Pacific Hub

QED India HQ at Ahmedabad

Regional home based staff at

Bangalore and Trivandrum

Experience of executing large

global Phase II to IV studies in

majority of the AP Market

QED

Ahmedabad

(Office)

Regional Staff

Bangalore

Regional Staff

Trivandrum


QED India is currently conducting the following:

Recruitment Acceleration and Quality Oversight in India for a global Phase IIIb/IV clinical

study - 600 patients across 06 sites

Recruitment Acceleration and Quality Oversight in India for a global Phase III clinical

study - 800 patients across 10 sites

Clinical quality assurance for a large global pharmaceutical company

Consultancy activities for an Indian medical device company

Start-up activities for a global Phase III study (feasibility and site selection)

QED India – Engagement Since Inception in

March 2012


QED India - Services

Feasibility and site selection

Project Management

Clinical Monitoring & Site

Management

Quality Oversight and Site Support

Services

Clinical Data Management

Biostatistics

Safety and Pharmacovigilance

Regulatory Consulting and

Submissions

Clinical Quality Assurance

Medical Writing


QED India Staff Experience

Extensive clinical monitoring, project management and quality oversight experience on global

Phase II-IV studies

Successfully delivered large complex clinical programs with high number of patients in India and

Asia Pacific region

Has experience managing high number of patient enrolment with highest data quality in

minimum time

Experience of training and working with research naïve as well as highly experienced sites

Excellent mix of local expertise enhanced with our knowledge of international regulations and

guidelines


QED India – Staff Therapeutic Experience

Therapeutic Area Expertise in India

Analgesia Infectious disease

Cardiovascular Nephrology

Central Nervous System/Neurology Oncology

Dermatology Ophthalmology

Gastroenterology Respiratory

Hematology Skeletal

Immunology Vaccines

Inflammatory disease Endocrinology and Metabolic disorders


QED India – Staff Therapeutic Experience


QED India– Staff Country-wise Experience


The QED DifferenceQuality, Efficiency, Delivery


Why QED?

Customized/flexible solutions to meet your program needs

Experienced team managing your projects

Unique Matrix driven quality delivery model to ensure deliverables are of high quality and

accepted international standards

Reliable knowledge of local requirements/regulations and hands on in-depth experience results

into operational efficiency

QED is unusual in the priority it places on satisfying our customer‘s relationship needs

Visible management involvement/supervision

High Cost efficiency


Partnering together – The QED Fit

Access to patients in 50+ countries

Over 1,100 clinical experts on the ground

More than 2,700 studies successfully completed

QED are relationship specialists

QED think globally and act locally

QED believe a better partnership means better service

QED provide service with a smile


OrphanReachClinical Research Consortium


OrphanReach™ is a Clinical Research Consortium consisting of local research service providers

throughout the world who are dedicated to Orphan and Rare Disease Drug Development.

Experienced professionals and organisations are consolidating their expert knowledge to provide

guidance and end-to-end solutions to sponsors who are developing rare disease treatments.

An established global infrastructure provides OrphanReach™ access to patients with rare

diseases in 50+ countries across 5 continents working with local experts who have conducted

clinical studies in a wide range of therapeutic areas.

To ensure consistent quality and standardisation, each clinical research affiliate is stringently

evaluated, selected and audited. Each affiliate follows the same quality management systems,

Standard Operating Procedures and Operations Manual globally.

Overview


Structure

PROGRAM MANAGEMENT ACCOUNT MANAGEMENT

ADVISORY PANELEXECUTIVE MANAGEMENT

AFRICA MIDDLE EAST ASIA PACIFICAMERICAEUROPE

Oxford PharmaGenesis

Strategic Communications Consultancy

CRMi

Contract Research

QED Clinical Services

Contract Research

QED Clinical Services

Contract Research

QED India

Contract Research


Advisory Panel

DR. MARLENE E. HAFFNERDr. Marlene E. Haffner has been involved with rare diseases for her entire medical and public health career. For 20 years she directed the Office of Orphan Products Development in the FDA. While in that position she was introduced to ARM and immediately became excited about their work and their energy. Marlene is a graduate of the George Washington University School of Medicine and the Johns Hopkins University Bloomberg School of Public Health. Her passion is making a difference in the lives of people so that their lives can be healthier and more productive. During her time with the Office of Orphan Products she oversaw the FDA approval of more than 300 products to treat rare diseases and more than 1000 in some stage of development toward FDA approval. In 2007 she was Executive Director, Regulatory Affairs at Amgen, Inc. After leaving in 2009 she formed her own consultancy company Haffner Associates.

MRS. ABBEY MEYERSMrs Abbey Meyers is the founder and President of the National Organisation for Rare Disorders (NORD), a coalition of national voluntary health agencies and a clearinghouse for information about these little known illnesses. Mrs Meyers served as the consumer representative on the National Commission on Orphan Diseases (1986-89), the NIH Human Gene Therapy Subcommittee (1989-92), the NIH Recombinant DNA Advisory Committee (RAC)(1993-96) and the FDA Biological Response Modifiers Committee (1995-99). Mrs Meyers continues to service the FDA’s Xenotransplantation Subcommittee and as an ad hoc consumer advocate for the FDA and NIH. A recipient of the FDA Commissioner’s Special Citation for Exception Dedication and Achievements (1988) and the Department of Health and Human Services award for Public Health Service for Exceptional Achievements in Orphan Drug Development (1985). Mrs Meyers holds an Honorary Doctorate from Alfred University in New York. Mrs Meyers is considered the primary consumer advocate responsible for passage of the Orphan Drug Act of 1983. She now provides consultancy services at her own consultancy firm ASM Consulting.


Early Development


Clinical Development


Orphan Disease Experience

By Therapeutic Area


Feature Local CRO OrphanReach “Global” CRO

Global Capabilities X ✓✓✓✓ ✓✓✓✓

Rare Disease Focus X ✓✓✓✓ X

Tailored Approach ✓✓✓✓ ✓✓✓✓ X

Pro-active Communication & Interaction ✓✓✓✓ ✓✓✓✓ X

Unbiased Site/Country Selection X ✓✓✓✓ X

Cost Effective ✓✓✓✓ ✓✓✓✓ X

High Personnel Retention ✓✓✓✓ ✓✓✓✓ X

Patient Recruitment & Retention ✓✓✓✓ ✓✓✓✓ ✓✓✓✓

Patient Advocacy Groups X ✓✓✓✓ X

Knowing KOLs ✓✓✓✓ ✓✓✓✓ ✓✓✓✓

One Contract – One Point Of Contact N/A ✓✓✓✓ ✓✓✓✓

Experienced, Dedicated Project Manager ✓✓✓✓ ✓✓✓✓ X

Site Motivation ✓✓✓✓ ✓✓✓✓ X

Benefits



A better partnership means better customer service

Contact:

Ali Sajjad Bohra Swadhin Khawas

Country Head & Director – Clinical Operations Manager – Site Operations

Tel: +91-79-6543 1583 Mob: +91-9036 112 006

Mob: +91-9824 094 749 E-mail: [email protected]

E-mail: [email protected]


QED in the Media

• Scrip Best CRO Finalists

• PharmaTimes Project Management & Recruitment Finalists

• PharmaTimes 2012 Article: „Delivering more with less“

• InPharm R&D Guide March 2012 Article: „New research alliances and the evolution of CROs“

• BioSpectrum April 2012 Article: „India to be Asia Pacific region hub for QED”

• Coverage in PharmaTimes, CenterWatch and PMLive on India Subsidiary creation

• The CRO Guide 2010: „The challenge of introducing standards in a global environment“

• The CRO Guide 2011: „Is global consistency in GCP interpretation an achieveable goal?“

• Henry Stewart Conference 2011 Presentation: „The Regulatory Requirement. Why SOPs?“

• Pharmafocus October 2011: „In Safe Hands“ - It used to be thought safe to outsource full service to the

biggest, but today many customers prefer the attention, agility and expertise of more innovative

approaches

• Pharmafocus November 2011: „Its a small world“ – Why globalisation of research is not about being big,

its about being smart


Case Study: Project Delivery


Case Study – Project Delivery (1/8)

Rescue of a global phase II study in an orphan haematological indication

Study objective Study design

Challenges

An international, phase II, exploratory

dose-finding study with cohort design, in

an orphan disease indication

Safety & efficacy of a single dose (IV injection,

changed to IV infusion with amendment) medication

in various dose levels and evaluation the appropriate

dose range for future Phase III

• Rare disease, first ever recombinant pAb product in human clinical trials

• Dissatisfied Sponsor

• Demotivated sites

• Exhausted patient pool

• Quality concerns

• Particles in the IMP led to recruitment put on hold, introduction of Amendment, change

in mode of administration




• Efficient handling of hand-over activities.

• Re-assessment of existing sites: motivation, patient population, training on

amendment of new IMP administration

• Identification, selection and set up of additional countries and sites with expertise and

high recruitment potential

• Coordination of Amendment submission and approval in existing countries (change in

IMP administration)

• Management of recruitment for remaining cohorts and completion of LPI on schedule




• QED implemented risk mitigation and recruitment plans to maximize recruitment efficiency

and achieved study milestones within the agreed timelines.

• QED implemented a cohort management plan to minimize time between cohorts and overall

study timelines.

• QED added strong local and central expertise to ensure successful management of

regulatory, import and export issues in the challenging countries.

• As a result, QED managed to provide overall cost savings.

• In light of the clinical trial results, the Sponsor further considers moving into Phase III with

the product.




QED conducted feasibility across 5 continents, in the following countries:

- Australia - Macedonia

- Belgium - Netherlands

- Bosnia Herzegovina - Poland

- Bulgaria - Serbia

- Canada - Romania

- Croatia - South Africa

- Czech Republic - Spain

- Dubai - Turkey

- France - UK

- Germany - Russia

- Hong Kong - Ukraine

- India - USA

- Israel

- Jordan

- Lebanon




Identification and selection of 8 additional countries with strong local expertise and motivated

sites with good patient recruitment potential

This image cannot currently be displayed.










USA UK SERBIA ROMANIA UKRAINE ISRAEL INDIA RUSSIA




212 patients identified

during pre-screening

(database & medical

records)

41 patients

screened

28 patients

enrolled

Post-amendment, countries and sites

selected by QED identified a total of

212 potentially eligible patients during

pre-screening from their database and

medical records

41 of the pre-screened patients were

screened

28 were enrolled




Post-approval of the amendment, completion of the remaining cohorts and enrolment of the remaining

28 patients in 8 months as compared to enrolment of 32 patients in 15 months under the management of

the previous CRO




Of the 28 patients enrolled:

4 patients were recruited from the original sites

24 from the new sites selected by QED

By successful implementation of

risk/mitigation and cohort

management plans, the time

between “cohort open” and “cohort

closed” (i.e. all patients enrolled in

the given cohort) has significantly

decreased when study managed by

QED compared to the previous CRO

0

2

4

6

8

75 mcg/kg cohort (11pts)

100 mcg/kg cohort (10 pts)

125 mcg/kg cohort (10 pts)



250 mcg/kg cohort part 1 (2pts)

250 mcg/kg cohort part 2 (4pts)

Best dose cohort (7 pts)


Case Study: Relationship Delivery


Case Study – Relationship Delivery

• Preferred provider for top ten pharma customer since 2008

• Total of 30 studies in critical programmes within Europe (UK, DE, HUN, FRA)

• Evolving relationship tailored to Sponsor needs

• pool of CRAs pre-trained by Sponsor during time of intensive activity

• provision of individual CRAs trained on request when Sponsor need reduced

• cost effective and flexible but trusted solution for Sponsor.


Case Study: Managing a Transformational

Delivery Model


Case Study – Managing a Transformational

Delivery Model (1/6)

International phase III trial in Osteoporosis

Study Design

Challenges

An international, phase III, placebo-controlled, multiple dose, parallel group, double blind study comparing

treatment in osteoporosis

• Regulatory approvals delayed due to:

• Sponsor manufacturing IMP at a

manufacturing plant which was not GMP certified

• Study design not approved by Ethics

• Disease therapy area controversial

• Previous CRO not submitting all documents

• Sponsor not having copy of submitted documents

• Transition of CRO during regulatory process

• Investigator meeting took place 2 weeks after transition of CRO

• Bulgarian regulatory authority moved offices delaying the approval

• Serious breaches at study site

• Unplanned interim analysis





Challenges Cont’d

• Communication pathways unclear, ineffective project management

• Delayed Study Start-Up and Study timelines could not be extended due to competitive drug

• No TMF for RoW countries

• Late implementation of unblinded CRAs to perform full accountability

• Limited study budget

• Change of Sponsor

• Late request to monitor screen failures

• Late decision by Sponsor to include Hungary

• For some countries outside the EU no specific regulatory timelines were available





• Introduced a highly experienced PM team for RoW countries

• Re-set communication channels and improved escalation routes

• Identified bottle necks and facilitated timelines

• Provided central regulatory support and advice to Sponsor on regulatory strategies

• Accessed established contacts with authorities via QED partners

• Fast scalability of CRA resources needed to meet aggressive monitoring timelines





• Relabeling plan drawn up and executed to prevent unblinding of IMP

• Implemented risk mitigation and recruitment plan to maximize recruitment

efficiency and achieved study milestones within the agreed timelines

• Implemented a team of unblinded CRAs to perform full accountability

• Worked efficiently within different time zones

• Managed potential serious breach, planning and executing an agreed way forward

with regulatory authorities




0

100

200

300

400

500

600

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7

Nu

mb

er

of

Pa

tie

nts

Ra

nd

om

ise

d

Month of Recruitment


Patients Randomised

Target Randomisation





• Target enrolment achieved on schedule

• Study closed on time and on agreed budget

• Potential Serious Breaches resolved without critical findings

• Study and TMF inspected by MHRA – no findings

• QED Partners exceeded expectations by delivering important regulatory advice on

issues. Costs were not covered in the Scope of Work.

• Consequently Sponsor decided that QED would be involved in MAA


Global Capacity

11%

11%

21%

18%

16%

4%

19%

Access to > 1,100

Clinical Research Professionals

Senior Management (122)

Project Manager (123)

Lead/Senior CRA (249)

CRA (208)

Regulatory (186)

Quality Assurance (46)

Other (226)


Capacity by Geography

MGT PM SCRA CRA Reg QA Other Total Staff

US &

Canada

36 10 30 17 1 5 3 102

South

America

2 3 4 9 1 2 9 30

Western

Europe

(WEU)

16 28 123 47 4 6 14 238

Central &

Eastern

Europe

(CEE)

33 30 49 59 80 12 6 104

Nordic/

Scandinavia

8 5 16 19 48 2 6 104

Africa &

Middle East

15 10 12 16 24 11 13 101

Asia 8 26 8 23 23 5 57 150

Russia 5 11 5 18 10 3 44 96



Date post:	11-Nov-2014
Category:	Health & Medicine
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Qed India credential presentation

Health & Medicine