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
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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
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
Page 8 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
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
Page 9 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
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
Page 10 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
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
Page 11 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
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
Page 12 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
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
Page 14 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
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
Page 15 of 19
©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
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