Qed India credential presentation

QED Credentials
November 2012

1 qed-clinical.com info@qed-clinical.com +44 (0)1908 251 480

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 Patient
Capacity Access &
Retention

Local Regulatory
Knowledge Insight


Capacity by Region

United States and Canada Central and Eastern Europe (CEE) Africa and Middle East
Belarus Egypt
Bulgaria Israel
South America Croatia and Slovenia Lebanon
Argentina Czech Republic Macedonia
Brazil Slovakia South Africa
Chile Hungary United Arab Emirates
Mexico Macedonia Qatar
Bolivia Poland Bahrain
Romania Oman
Serbia and Montenegro Kuwait
Slovenia Jordan
Western Europe (WEU) Turkey Iran
UK Greece
Belgium Ukraine
Asia
France India
Germany China
The Baltics Vietnam
Austria
Switzerland Estonia Sri Lanka
Italy Latvia Bangladesh
Netherlands Lithuania Philippines
Portugal Japan
Spain Nordic / Scandinavia Taiwan
Australia
Denmark Malaysia
Russia Finland New Zealand
Sweden South Korea
Norway Singapore
Thailand


Regional Coordination

QED European
Hub

QED North
American
Hub

QED Asia
Pacific Hub

On-going/ previous Start-up phase


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….

Delivery

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


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 Processes Operational
and In-depth and Tools Excellence
Experience

Across the entire Study/Program


Quality Delivery Model

High Quality
Data
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

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


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

Total # Total #
Therapeutic Area Studies Therapeutic Area Studies
Completed * Completed*
Oncology 356 Respiratory (incl. Allergy) 207
Haematology 121 Gynaecology / Women’s 121
Health
Cardiology / Cardiovascular 223
Gastroenterology 158
Infectious Diseases 168
Immunology 63 Rheumatology 162

Endocrinology /Metabolic Dermatology 111
222
Disorders
Pain 86
CNS (Neurology &
265 & 157 Vaccines 128
Psychology)
Urology 139 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 QED
Ahmedabad
global Phase II to IV studies in
(Office)
majority of the AP Market

Regional Staff
Bangalore

Regional Staff
Trivandrum


QED India – Engagement Since Inception in
March 2012

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 - Services

Feasibility and site selection Biostatistics

Project Management Safety and Pharmacovigilance

Clinical Monitoring & Site Regulatory Consulting and
Management Submissions

Quality Oversight and Site Support Clinical Quality Assurance
Services Medical Writing
Clinical Data Management


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 Difference
Quality, 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


OrphanReach
Clinical Research Consortium


Overview

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.


Structure

EXECUTIVE MANAGEMENT ADVISORY PANEL

PROGRAM MANAGEMENT ACCOUNT MANAGEMENT

EUROPE AMERICA AFRICA MIDDLE EAST ASIA PACIFIC

QED Clinical Services CRMi QED Clinical Services QED India
Contract Research Contract Research Contract Research Contract Research

Oxford PharmaGenesis
Strategic Communications Consultancy


Advisory Panel

DR. MARLENE E. HAFFNER
Dr. 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 MEYERS
Mrs 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


Benefits

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


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: skhawas@qed-clinical.com

E-mail: asbohra@qed-clinical.com

A better partnership means better customer service

qed-clinical.com info@qed-clinical.com +44 (0)1908 251 480


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
An international, phase II, exploratory Safety & efficacy of a single dose (IV injection,
dose-finding study with cohort design, in changed to IV infusion with amendment) medication
an orphan disease indication in various dose levels and evaluation the appropriate
dose range for future Phase III

Challenges

• 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 display ed.




This image cannot currently be
This image cannot currently
This image cannot currently be display ed. This image cannot currently be display ed.
display ed. be display ed.
This image cannot currently be
display ed.

USA UK SERBIA ROMANIA UKRAINE ISRAEL INDIA RUSSIA




Post-amendment, countries and sites
212 patients identified selected by QED identified a total of
during pre-screening 212 potentially eligible patients during
(database & medical pre-screening from their database and
records) medical records

41 patients 41 of the pre-screened patients were
screened screened

28 patients
28 were enrolled
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




8

6 Of the 28 patients enrolled:
4
4 patients were recruited from the original sites
2

0 24 from the new sites selected by QED

75 mcg/kg cohort (11pts)
By successful implementation of
100 mcg/kg cohort (10 pts)
risk/mitigation and cohort
125 mcg/kg cohort (10 pts) management plans, the time
200 mcg/kg cohort (5pts) between “cohort open” and “cohort
closed” (i.e. all patients enrolled in
250 mcg/kg cohort (5pts)
the given cohort) has significantly
250 mcg/kg cohort part 1 (2pts)
decreased when study managed by
250 mcg/kg cohort part 2 (4pts) QED compared to the previous CRO
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
An international, phase III, placebo-controlled, multiple dose, parallel group, double blind study comparing
treatment in osteoporosis

Challenges

• 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



600

500
Number of Patients Randomised

400

300
Patients Randomised
Target Randomisation
200

100

0
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7
Month of Recruitment



• 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

Access to > 1,100
Clinical Research Professionals

11%
19% Senior Management (122)
11% Project Manager (123)
4% Lead/Senior CRA (249)
CRA (208)
Regulatory (186)
16% 21% Quality Assurance (46)
Other (226)

18%


Capacity by Geography

MGT PM SCRA CRA Reg QA Other Total Staff

US & 36 10 30 17 1 5 3 102
Canada

South 2 3 4 9 1 2 9 30
America

Western 16 28 123 47 4 6 14 238
Europe
(WEU)

Central & 33 30 49 59 80 12 6 104
Eastern
Europe
(CEE)

Nordic/ 8 5 16 19 48 2 6 104
Scandinavia
Africa & 15 10 12 16 24 11 13 101
Middle East

Asia 8 26 8 23 23 5 57 150

Russia 5 11 5 18 10 3 44 96


Qed India credential presentation

Recommended

Recommended

More Related Content

Similar to Qed India credential presentation

Similar to Qed India credential presentation (20)

Recently uploaded

Recently uploaded (20)

Qed India credential presentation