2011 Clinical Trials Honour Roll - The Clinical Trials Honour Roll

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May 20, 2011 - CROs and CMOs conduct trials safely, quickly and cost effectively. Dr. Alaa Abou-Zeid ..... Research Unit
2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011 INTRODUCTION Medical research is widely recognised by the community as a valuable service. Clinical trials are a subset of human research involving an intervention that provide the evidence to translate ideas and discoveries into clinical practice. A variety of stakeholders, both volunteer and professional, must work together in partnership to make clinical trials happen. Without scientists, investigators, nurses, funding, infrastructure and equipment, regulatory and ethical oversight, collaboration, monitoring and human volunteers, contributing time and resources to clinical trials, medicine would not advance as quickly or as safely. This Honour Roll provides the opportunity to celebrate all the individuals and organisations that have nominated themselves or others for their contribution to clinical trials over the past year. A special congratulations goes to Mrs Margaret Morton who has won the ARCS Australia sponsored award of the Most Nominated Individual in Australia on the 2011 Honour Roll. Congratulations to everyone for your contribution to clinical trials. The entire community benefit from your contributions to and achievements in research. Thanks also to our financial and in-kind supporters, without whom the Honour Roll would not be possible. We hope more will join this list of inspired organisations committed to the value of clinical trials and recognising those involved in the future. SILVER SPONSORS

MOST NOMINATED AWARD AUSTRALIA

http://www.nucleusnetwork.com.au

IN KIND SUPPORTERS

http://www.ARCS.com.au

http://www.AccessCR.com.au

Certificate Image © Marc Dietrich | Dreamstime.com

To learn more about the Clinical Trials Honour Roll, please visit: http://www.ClinicalTrialsHonourRoll.com www.ClinicalTrialsHonourRoll.com

Page 1 of 19

©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011 INDIVIDUALS The following individuals listed themselves or were nominated by peers for recognition of their contribution to clinical trials over the past year (in alphabetical order). Name

Type of Organisation

Location

Contribution to Clinical Trials

Dr. Abdalla A.Awaidi

University

Jordan

Dr. Abdallah is a remarkable researcher and the best candidate for clinical research in Jordan. He has worked on several Investigator initiated clinical studies

Dr. Abla Al-Bsoul

Ethics Committee / Research Governance

Jordan

Dr. Abla is one of the first IRB members in Jordan who set the rules and policies for the IRBs and currently she is working as a member of the clinical stuides committee at JFDA

Adil Shafique

Commercial organisation running trials, Training Provider, Healthcare IT

Global

Delivering end-to-end clinical trial solutions, data management and our single delivery method, VTRIAL™ CTMS. Our committed team helps Sponsors, CROs and CMOs conduct trials safely, quickly and cost effectively.

Dr. Alaa Abou-Zeid

Commercial organisation running trials

Cairo, Egypt

Supported research Institutes and researchers to conduct clinical trials with technical support and advice on design, conduct, data management and medical writing/editing. Promoted GCP standards by training and supporting compliance.

Professor Albert Frauman

Commercial Organisation Running Trials

Australia

Over 30 years in clinical research and is an expert in drug trials and pharmacokinetic studies. Longstanding activities in clinical medicine, teaching and research as a hospital and academic physician.

Dr. Alfred Bacharach, PhD

Medical research institute / ARO

Rio de Janeiro, Brazil

Dr Bacharach is (or was) a Clinical Director of Nichols Institute. He is about to retire so this is the right moment to honor his work and discoveries in the field.

Andrew Giddy

Commercial Organisation Running Trials

Australia

Over 15 years clinical research experience including 9 years in big pharma working on Phase I-III trial management in all areas from local site management to global study management. Numerous leadership positions in Australia and internationally. Currently, CEO of Nucleus Network

www.ClinicalTrialsHonourRoll.com

Page 2 of 19

©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Anja van 't Hoog

University

Netherlands

Van 't Hoog and her team contributed to clinical trial capacity building in Kenya and created a vast network of cohorts for future TB studies.

Associate Professor Anna Hawkes

Medical research institute / ARO

Australia

Senior Research Fellow at the Viertel Centre for Research in Cancer Control, adjunct A/Professor at Queensland University of Technology and James Cook University. Currently leading clinical trials / investigator driven chronic disease research.

Annette Leahy

Commercial Organisation Running Trials

Australia

Clinical Project Manager with over 15 years experience in Phase 1-4 clinical research in pharmaceutical and CRO settings. Experienced in the UK and European regulatory framework.

Ms Annette Pidoux

Hospital

Sydney, Australia

Clinical Trials Coordinator providing outstanding support of clinical trials conducted at St Vincent’s Hospital

Dr. Ayman Hamoudeh

Hospital

Jordan

Dr. Ayman is one of the Investigators that any CRA would really like to work with and learn from. Dr. Ayman has conducted several researches in Cardiology area.

Barbara Lester

Commercial Organisation Running Trials

Australia

Group Technical Manager. Over 15 years experience as Medical Scientist working in hospital pathology laboratories. Currently responsible for all technical operations related to the conduct of clinical trials at Nucleus Network

Bianca Scott

Commercial Organisation Running Trials

Australia

Clinical Project Manager with 5 years nursing and clinical research experience in Phase I-4 trials

Carli Hunter

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Dr Carlo Maccarrone

Professional/Industry Organisation

Australia

Working with various Australian stakeholders to positively influence the clinical trials environment in Australia

Carolyn Stewart

Commercial Organisation Running Trials

Australia

Over 20 years experience in clinical research with more than 15 years in the biopharmaceutical industry in various clinical operation roles. Broad experience in drug development within Australia as well as the US, UK and Eastern Europe.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Mrs Charlotte Nonhlanhla Mahuma

NINR Comprehensive Local Research Network

England

Delivering face to face GCP training, educating and mentoring research nurses (both new and experienced), and supported department to become research active and contribute to high quality NIHR portfolio trials.

Prof.Dr. Chifumbe Chintu

University

Zambia

His study of antiretroviral treatment of children with HIV contributed to FDA approval of Triomune Baby/Junior and to the definition of pediatric optimal weight bands by WHO.

Dr. Christian Happi

University

Nigeria

Christian Happi's contribution to malaria research is outstanding especially in the field of drug resistance.

Queensland, Australia

Cindy has been a Clinical Research Coordinator, and CRA, in clinical trials for 21 years and is a passionate and active advocate for this field of research.

Ms Cindy Hall Corie Lynn

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Ms Corina Jary

Hospital

WA, Australia

Clinical Nurse Consultant providing outstanding support of clinical trials conducted at Royal Perth Hospital

Craig Rogers

Commercial Organisation Running Trials

Australia

Over 20 years in Big Pharma and Biotech start-up companies. Leadership roles in regulatory affairs, drug development and manufacture and has successfully filed INDs, DAs and General Marketing Applications in the USA, EU, Australian and Asian markets.

Dada Hayath.Shaik

Commercial organisation running trials (eg pharma, biotech, devices, CRO), Trial network / SMO, Hospital, Training Provider

Hyderabad,In dia

Postgraduate in Biotechnology with more then 5yrs experiance in Clinical trials phase1-phase4,BA/BE studies

Dalia Saleh

Professional/Industry Organisation

Jordan

Dalia is an intelligent and creative clinical research professional , she project managed a phase II trial effectively and 2 Phase IV studies. Dalia has passed the ACRP certification exams - CCRC and CCRA.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Mrs Danita Kapp

Hospital

Australia

Danita is an instrumental leader for our clinical trials team at the Townsville Hospital. She is highly regarded by all her colleagues.

Mr Darryl Carrington

Commercial organisation running trials (eg pharma, biotech, devices, CRO)

Australia

Clinical Research Manager for GSK

Dr. Darwish Badran

Ethics Committee / Research Governance

Jordan

Dr. Darwish is an IRB Chair who sets an example for the responsible and reliable Chair. He's been always committed to his work as a chair although it's not a full time job and not compensated as it should be.

David A Olson, MD

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net with over 20 years of experience.

Dr Dimitar Sajkov

Medical research institute / ARO, Hospital, University, Ethics Committee / Research Governance office, Training Provider

Adelaide, Australia

I am the principal Investigator in several multi-centre and single centre clinical trials including new influenza vaccines and vaccine adjuvants, clinical research databases, COPD, Asthma and sleep disorders.

Dolima M S

Hospital

India

A very hard working and dedicated CRC who has a passion for clinical research and has been devoting her full time for clinical research.

Elizabeth Heyer

Hospital

Australia

Highly motivated Clinical Research Coordinator, meticulous in her job. Great advocate for Radiation Oncology Trials.

Elizabeth Heyer

Hospital

Queensland, Australia

Elizabeth is an outstanding Clinical Research Coordinator making the experiences of Radiation Oncology patients participating in clinical research a very positive one.

Emad Shafout

Professional/Industry Organisation

Jordan

Emad was one of the first CRCs who worked in clinical trials in Jordan and worked hard to get to be a CRA in a regional CRO

Glenda Yarbrough, CCMA, CCRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Hanan Kakish

Independant Contractor

Jordan

Hanan is an added value for the pharmaceutical industry in Jordan and now for the clinical research professionals. She used to work as a study monitor and now she has passed the ACRP CRA certification exam.

Queensland, Australia

Heather has designed, developed and implemented the Central Coordination Service at Queensland Heatlh

Mrs Heather Hawkins Hee Chun Yang

Medical research institute / ARO

Malaysia

Performing clinical research independantly.

Helma Verbraeken

Medical research institute / ARO

Europe and Latin America

Helma is a Clinical Trial Assistant who provides an exceptional assistance to the clinical trial team in an international ACS study run across 24 countries. She has a remarkable attitude of helping and excellence in her work and is a pleasure to work with.

Ilham Swaidan

Ethics Committee / Research Governance

Jordan

Ilham is a highly qualified IRB coordinator, assisting in maintaining compliance to applicable regulations

Dr.Indra Bhadu

Medical research institute / ARO, Government, Hospital

India

I really appreciate enthusiasm and dedication towards clinical research and responsibility for coordinating with Investigators, Research Institutes and CROs.

Jacqui Waterkeyn

Commercial Organisation Running Trials

Australia

Over 15 years experience in research. Worked in Biotech, Big Pharma and Medical research in regulatory affairs, quality assurance, project management, clinical trials consulting for product development on drugs and devices and operation management.

Queensland, Australia

Jane is the Director of Research Ethics and Coordination at the Office of Health and Medical Research at Queensland Health. Jane works tirelessly to facilitate research within Queensland Health sites.

Ms Jane Jacobs

Dr Janelle Bowden

Independent Contractor, Advocate

Australia

Janelle is committed to building knowledge, capacity and efficiency in clinical research, and increasing awareness and understanding of clinical research in the community.

Joshua A Turknett, MD

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net with over 10 years of experience.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Judith Page

Hospital

Queensland, Australia

Judith is a very energetic and dedicated clinical research coordinator. Her work is of outstanding quality and she is making a huge contribution to Medical Oncology Clinical Trials for North Queensland oncology patients.

Dr Judy Stone

Independant Contractor

USA

Dr Judy Stone is a clinical investigator with over 20 years experience running clinical trials, which she has passed on with her book Conducting Clinical Research. This is a great resource for sites looking to improve their clinical trial operations.

Ms Karen Brown

Hospital

Sydney, Australia

Clinical Trials Coordinator providing outstanding support of clinical trials conducted at St Vincent’s Hospital

Karen Young, LPN, CCRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

A/Professor Kazuko Masuo

Commercial Organisation Running Trials

Australia

An extensive career in clinical research including numerous Phase I ethnopharmacology studies - Japanese Bridging Studies. Over 30 years experience including practical medical experience as a cardiologist, endocrinologist and nephrologist and medical research in Japan.

Kimberley Bury

Hospital

Queensland, Australia

Kimberley is a clinical research coordinator for Haematology Oncology Clinical Trials at The Townsville Hospital. Her attention to detail and coordination is of very high quality and she is a great asset to clinical trials.

K.S.K.Naveen

Professional/Industry Organisation

India

I am currently a CTA working on 2 studies in Diabetes and Psychiatry in India.

Laurie Caldwell, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Lavanya Veda, CCMA, CCRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Leah Craft, CCRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Lisa Nelson

Commercial Organisation Running Trials

Australia

Over 25 years experience in Medical Research Industry. Has consulted to key research institutions and Scientific, Medical Research and Government sectors developing, writing and implementing feasibitlity and assessment studies.

Mrs Lisa Palla

Commercial organisation running trials (eg pharma, biotech, devices, CRO)

Brazil, Europe, USA and Latin America

I am currently a CRA working on 3 studies in glaucoma, gynecology and respiratory with more than 300 patients in Brazil

Ms Lynn Hughes

Commercial organisation running trials (eg pharma, biotech, devices, CRO)

Australia

Clinical Research Manager - Oncology portfolio

Maha Al-Farhan

Professional/Industry Organisation

U.A.E

Maha took the lead in the region to establish the first CRO in the early 2000s

Mahesh Malneedi

Trial network / SMO, Equipment/technology/C TMS/EDC/service provider, Professional/Industry Organisation

India

Established a complete CRO with end to end Services including SMO with IT technology

Dr.Mallikarjun V.Jali, MD, FICP

Medical research institute / ARO, Hospital, University

India

Dr.M.V.Jali from KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Belgaum in India has been training healthcare and clinical research professionals and advocating for skills certification of technicians and research scientists.

Manal Milhem

Professional/Industry Organisation

Jordan

Manal is a perfectionist in her work and always striving to upgrading the clinical research quality to the best standards. She's worked as a CRA, clinical program manager and a regional manager.

Dr. Marc K. Taormina

Research site

Missouri, USA

Investigator for GI trials specializing in IBD treatment with a focus on the whole patient and his/her health and quailty of life.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Ms Margaret Morton

Hospital

Australia

Margaret is the Senior Clinical Research Coordinator with the Geriatric Research Unit, Prince Charles Hospital. She has had extensive clinical drug trials experience, and is very passionate and committed to this field of study, actively participating in forums and organisations aimed at implementing change and improvements within the clinical research spectrum.

*Most Nominated Individual in Australia

Margie is very commited and takes great pride in her work. Her extensive knowledge and dynamic approach have been a great support to staff at both TPCH and other research sites. Margie is a Clinical Research Coordinator and approaches all CRC responsibilities with a high level of professionalism. She goes above and beyond the call of duty for her Sponsors and patients. Prof. Dr. Marie Louise Newell

University

South Africa

Prof. Newell coordinated the Kesho Bora studies that have influenced the WHO policy change for prevention of mother to child HIV transmision.

Prof. Dr. Mark Nicol

University

South Africa

Mark Nicol contributed to the study that established the efficacy in field conditions of the GeneExpert MBT/RIF rapid diagnostic test for (multi-drug resistant) tuberculosis.

Marshall L Nash, MD, FAHA, CPI

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net with over 20 years of experience.

Mary Franich

Commercial Organisation Running Trials

Australia

Recruitment Manager with Phase I/ Early Phase Clinical Trial Experience. Extensive expeirece in devising and implementing recruitment strategies and in co-ordinating advertising campaigns.

Mayur Salat

Commercial organisation running trials (eg pharma, biotech, devices, CRO)

India / Canada

More than two year of experience as CRA/ Pharmacist for Phase I to Phase III clinical trials in India and Canada. Good knowledge of ICH- GCP, relevant regulatory guidelines and other relevant areas of clinical research.

Ms Melissa Hirth

Medical research institute / ARO

Melbourne, Australia

Modified relative motion splinting in the post-operative management of zone V & VI extensor tendon repairs.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Meenakshi Sharma

Hospital

India

Meenakshi has been working as a workoholic CRC on number of clinical drug trials since last 2 Years. Her dedication to quality data, protection of ethical rights and passion for learning deserve a recognition.

Dr. Michael Rosenberg, MD, MPH

Commercial organisation running trials (eg pharma, biotech, devices, CRO), Equipment/technology/C TMS/EDC/service provider

NC, USA

Dr. Rosenberg founded an efficiency-driven global CRO, Health Decisions®. His research innovations after conducting >300 studies have resulted in significant improvement and cost-savings. He is currently co-principal investigator of the Clinical & Statistical Coordinating Center for Contraceptive Research, NIH.

Murad Faron

Professional/Industry Organisation

Jordan

Murad added his 8 year experience and knowledge to the portfolio of the clinical team in his organization. He has passed the ACRP CRC certification exam recently.

Myrna Whiting, CCMA, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Dr. Nadia Zaki

University

Egypt

Dr. Nadia is the Clinical Director of Alexandria Clinical Research Center, and has worked as a dedicated PI in several clinical trials

Dr. Naida Gurshumov, GNA Research

Independent Contractor

Israel

Dr. Gurshumov, PhD, CCRA, is an independent clinical research consultant, who contributes her knowledge and more than 15 years experience in clinical trials to international pharma, medical device and CRO companies.

Dr. Naser Idkeidek

University

Jordan

As a biostatistician, Dr. Naser is one of the few in the region who proved that a good statiistician is an indicator for quality research. He has done the role of a biostatistician and kinetist in more than 1000 studies.

Ms Natalee Lawson

Hospital

WA, Australia

Research Officer providing outstanding support of clinical trials conducted at Royal Perth Hospital

Nedal Al-Rawashdeh

Hospital

Jordan

Nedal is considered a natural organizer, with a good, practical, 'no fuss' approach to the most demanding work situations upon his work as a CRC in KHCC for several Oncology studies.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Ms Nicola Bush

Commercial organisation running trials

Australia

Nicola is an incredibly capable and dedicated CRA, professional at all times, keeps on top of a demanding workload, handles anything with grace and accomplishment, consistently supports her sites and clients competently, and has the trust and confidence of her colleagues.

Nina Caltabiano, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Mr. Nirav Jansari

Commercial organisation running trials

Ahmedabad, India

Work as a medical writer, CRA, and in project co-ordination from preparation of regulatory documents, conducting clinical trials to resolving regulatory audit findings. I work domestically and internationally, and cross-functionally across QA, DM, regulatory, etc at different stages of trials.

Patricia Lawler

Commercial Organisation Running Trials

Ireland

Patricia established Scope Clinical Research, a small Irish CRO that has been providing training and operations staff to support clinical trials in Ireland and beyond since 1993.

Pauline Cahill

Hospital

Australia

Established and has managed the cardiology clinical trial unit in Coffs Harbour since the mid 1980's

Mrs Pauline Keays

Hospital

Australia

I have been involved with Cardiac Clinical Trials for 20 years, and put in a lot of extra unpaid hours towards this worthy cause. Has assisted in Cardiology Clinical Trials as a Research Coordinator for the past 6 years

A/Prof Peter Hodsman

Commercial Organisation Running Trials

Australia

Principal Investigator or Sub-investigator for over 100 clinical trials. Direct responsibilitiy for over 200 clinical trials in Australia and Asia. Over 50 Phase I/ First into human trials. Over 20 years pharmaceutical industry clinical research experience.

Dr. Pravin Ahir

Commercial organisation running trials

India

Providing accurate feasibility data and project initiation globally.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Ms. Priya. A

Commercial organisation running trials

India

Completed M.Sc clinical research and now teaching clinical research to M.Sc students. Two batches of students have passed through and are now working in different clinical trial sectors.

Dr. Rabab Tayyem

Other

Jordan

Prominent figure in Jordan who has trained and educated many in the area of clinical trials and bioequivalence research

Raeda Mustafa

Professional/Industry Organisation

Jordan

Raeda is one of few who have been certified as a clinical research professional (CCRC and CCRA) in the region in 2007 ,has worked in the field for 12 years and is the founder of molecule CRO.

Dr.Rajendra Mehta

Principal Investigator

India

I am working as principal Investigator for the last 4 years & did 15 clinical trials in Asthma & COPD, mostly global. I spent >20 hours per week for clinical research apart from my private practice as consultant Chest Physician.

Dr Rakesh Kumar Maliram Parikh

Hospital

India

In a short span of 2 years, I have been recognised as one of the most favourite investigators through quality work and full dedication for clinical research. Have been the PI for 5 completed and 4 ongoing phase III global studies in diabetes and have around 40 research papers.

Rana Damsees

Professional/Industry Organisation

Jordan

Rana always proved that she is one of the most creative and intelligent coordinators available in Jordan through coordinating several BE studies and supervising the clinical operations during the last year.

Rana Hassan

Professional/Industry Organisation

Jordan

Rana is a multitasked person that proved her ability to raise the standards of clinical practice in her organization. Rana has passed the ACRP CRA certification exam recently.

Rebecca Heintzelman, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Robin Luber

Commercial Organisation Running Trials

Australia

Over 15 years experience working in Quality Management and Quality Assurance Systems and has extensive knowledge on Compliance and Risk Management, Quality System Development and Implementation for the Clinical Research industry and Learning and development facilitation.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Robin Jackson

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Robyn Lichter

Commercial Organisation Running Trials

Australia

Introduced and implemented internationally recognised Good Clinical Practice Classroom courses, online courses and GCP certification nationally throughout Australia

Dr Roger Engel

University

Australia

Is a leader in the field of clinical research in to the use of manual therapy in the management of chronic respiratory disease.

Ruhaifa Mahmoud

Professional/Industry Organisation

Jordan

Ruhaifa is the best choice for challenging tasks and responsibilities. She has learnt the job of a CRA in a considerable short period and did it in a perfect manner

Saleh Hussein

Professional/Industry Organisation

Jordan

Saleh worked is an IT consultant and was able to provide the IT smart solution for 3 clinical studies to be in compliance with the international standards and regulations. Saleh is the founder of MENA CLINICAL.

Seu Siow Bee

Medical research institute / ARO

Malaysia

Performing clinical research independently.

Shada Sayegh

Professional/Industry Organisation

U.A.E

Shada has been selected as the recipient of 2011’s Leadership as a Project Manager Award by ACRP

Mr. Shanker Krishnamoorthy

Commercial organisation running trials (eg pharma, biotech, devices, CRO)

Bangalore, India

Currently as a Senior Clinical Research QA Associate, I worked for 12 projects including Oncology, Gastroenterology, Rheumatoid arthritis, Ophthalmology and Diabetology trials. I have trained >50 employees on various regulations and reviewed clinical trial documents before ethics committee/regulatory submissions.

Shanna Bruflodt, CCRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Shannon Doppelheuer, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Mr. Shekhar Goyal

Trial network / SMO, Independent Contractor

India

I am working in global level trials and linkage between CRO & Investigators.

www.ClinicalTrialsHonourRoll.com

Page 13 of 19

©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Sherry Myers, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Stacy Damm, CRC

Professional/Industry Organisation

USA

Dedicated to finding cures through neurology research at NeuroStudies.net.

Mr Steve Bukvic

Professional/Industry Organisation

Singapore

Steve has been instrumental in leading the Clinical Research arena in operations and training and setting up PACRA (Pan-Asian Clinical Research Association)

Sue Mason

Commercial Organisation Running Trials

Australia

Clinical Project Manager with over 15 years nursing experience and over 10 years Phase 1-4 clinical research experience. Peri-operative certified nurse

Queensland, Australia

Sue has help introduce single ethical review to Queensland Health and is very much involved with HoMER

Ms Sue JenkinsMarsh Suzy Cake

Commercial Organisation Running Trials

Australia

Clinical Project Manager with Phase I/Early Phase Clinical Trial experience

Dr. Tamer Hifnawi

University

Egypt

Dr. Tamer is a trainer and clinical researcher who is working on enhancing the standards in Egypt and the region.

Dr Timothy Low

Professional/Industry Organisation

Singapore

Dr. Low has been integral in establishing the footprint for global CRO in Asia and assisted with expanding PACRA (Pan-Asian Clinical Research Association)

Dr Tina Soulis

Commercial organisation running trials (eg pharma, biotech, devices, CRO)

Global; Head office Melbourne, Australia

Has made a major contribution to the Australian biotech industry by taking a product through all phases of clinical development and was part of the team that gained its FDA approval.

Tina Avanzato Chiodo

Independant Contractor

USA

Tina is a clinical research consultant with a wealth of experience and knowledge about clinical trials that she shares via Twitter. Her tweets via account @GCPWorks have been recognised for the high quality of clinical research related information.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011

Name

Type of Organisation

Location

Contribution to Clinical Trials

Violeta Antonijevic

Commercial Organisation Running Trials

Australia

Screening Manager for Phase I/ Early Phase Clinical Trials including over 25 years of nursing experience

Mr.Vishal Barge

CRA

Mumbai, India

At present working as a CRA on severe hypertriglyceridemia studies and as a CRC, worked on various therapeutic areas e.g. osteoporosis,Type 2 Diabetes, Cervical Cancer & Cataract.

Mr Vishal Gopal

Commercial organisation running trials

Australia

Assisting the conduct of a Cardiovascular/Diabetes clinical trial in Australia, New Zealand, Malaysia, India and China.

Wael Tarhini

Independant Contractor

Lebanon

Wael ia a skillful and hardworking CRA. He possesses the character of a CRA and passed the ACRP certification exam the first time.

Wafa' Al-Khatib

Government

Jordan

Dr. Wafa' is basically the founder of the recent Clinical Trials Unit at Jordan FDA and a member of the clinical studies committee at JFDA

Ms Yasmin Abdel Rahim

Hospital

Jordan

This person is a clinical research coordinator that has been responsible for 3 registry studies and 4 clinical trials in oncology research

Dr.Sreedhar Tirunagari

Commercial organisation running trials, Medical research institute / ARO, Trial network / SMO, Hospital, University

Hyderabad,In dia

He is a qualified Medical doctor with > 10yrs experience in Healthcare , participating in more then 20 Clinical trials – Phase I-IV and many registry trials; He developed a GCP help desk for compliance adherence in clinical trials in India and tools for site management operations; He conducted GCP trainings and brought in E-site concept; He developed SOP's for site management operations; He is conducting clinical trials in Srilanka, speeding the process of submission for ERC; Provides site training during start-up and conducts clinical trials in Srilanka; He developed the Global SMO division of Makrocare Clinical Research, has participated in Registry trails in multiple TA's (Health outcome Research).

Ms Yvonne Baillie

Commercial organisation running trials

Australia

Yvonne has project management down to a fine art. She has superb technical skills, excels in project delivery, establishes good relationships with clients, produces high-performing teams, is always willing to share her knowledge and is continuously looking for ways to improve herself.

www.ClinicalTrialsHonourRoll.com

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©2011 AccessCR Pty Ltd (Australia)

2011 Clinical Trials Honour Roll International Clinical Trials Day, 20 May 2011 ORGANISATIONS The following organisations listed themselves or were nominated for recognition of their contribution to clinical trials in the past year (in alphabetical order). Name

Type of Organisations

Location

Contribution to Clinical Trials

ARCS Australia

Professional/Industry Organisation

Australia

ARCS Australia provides professional development in therapeutics, and is a proud supporter of its members in the clinical research profession.

Australasian Leukaemia and Lymphoma Group

Cooperative Clinical Trials Group

Australia and New Zealand

Improving the treatment and the lives of patients with blood cancers via clinical trial research

Australian Respiratory and Sleep Medicine Institute

Medical research institute / ARO, Hospital, University, Consumer/Charity organisation

Australia

In