Consulting for Principal Investigators

Are you planning an international investigator initiated trial? Are you planning to open a new study site for your already running clinical trial? Is a rare disease the focus of your research? Have you slow recruitment paces or do you simply want to gather information about different patients’ characteristics? Going abroad might the right solution for you!

Some issues may come up during the planning phase, though. Questions such how to contact the right partners/study centers, what regulations are applicable, what regulatory bodies and ethics committees are involved, how big should the sample be or whether the study is feasible or not…, although overwhelming, must be all taken into account.

ICN, an academic network promoting excellence in clinical research, is willing to assist investigators during the preparation of international investigator initiated trials and is therefore offering a free, short consulting service. If needed, the initial free service could be followed by a chargeable, more intensive, consulting.

Please use the following link to send your inquiries: info@icn-connect.org
Alternatively, you could directly contact one of our consultants below

We look forward to assisting you in a near future!

Dr. Creany Wong

ICN Member:
Clinical Trials Centre, The University of Hong Kong, Hong Kong (HKU-CTC)

Contact Person:
Dr. Creany Wong

Further Information

Current Position:
Associate Director, Business & Project Intelligence

Experience:
HKU-CTC is an academic clinical research organization under The University of Hong Kong. Established in 1998, its team now has 60 dedicated clinical research professionals that together are capable of providing comprehensive, one-stop services covering site management organization services (SMO services), contract research organization services (CRO services), phase 1 and clinical pharmacology trials management (phase 1 centre and pharmacokinetics laboratory management), and professional training on clinical research. Dr. Wong has been of service with HKU-CTC for over 12 years and welcome inquiries on any matter relating to clinical research in Hong Kong and Mainland China. Services are available in English and Chinese (including Mandarin and Cantonese).

ecreanywo@hku.hk

Dr. Silvia Egert

ICN Member:
Münchner Studienzentrum, School of Medicine, Technical University Munich, Germany

Contact Person:
Dr. Silvia Maria Egert-Schwender

Further Information

Current Position:
Consultant for study design and budget planning

Experience:
Dr. Egert-Schwender belongs to the scientific staff of the Münchner Studienzentrum since 2003 and has long-term experience in conception of clinical trials, trial budgets and trial applications to national and international public, private or commercial funding institutions.

silvia.egert@mri.tum.de

Ali Yağız Üresin, Prof., MD

ICN Member:
Istanbul University Center of Excellence for Clinical Research (IUKAMM)

Contact Person:
Ali Yağız Üresin, Prof., MD

Further Information

Current Position:
Head of the Department of Medical Pharmacology and Division of Clinical Pharmacology in the Istanbul Faculty of Medicine at University of Istanbul. Vice-Director of IUKAMM. Chairperson of the Ethics Committee of Istanbul Faculty of Medicine.

Experience:
He performed clinical trials on phase I to IV, has documents at FDA, was investigator and principal investigator in many international multicenter clinical trials. He also coordinated and organized many basic and advanced training activities on the topic of clinical trials.

yagiz@istanbul.edu.tr

Selçuk Şen, Asst. Prof., MD

ICN Member:
Istanbul University Center of Excellence for Clinical Research (IUKAMM)

Contact Person:
Selçuk Şen, Asst. Prof., MD

Further Information

Current Position:
Assistant professor of medical pharmacology in the Faculty of Medicine at Istanbul Bilim University.

Experience:
He worked at Istanbul Faculty of Medicine between the years of 2008 and 2017 and is currently a guest lecturer. He joined several local and international clinical trials on phase I to IV as an investigator, worked as an ethics committee member and also contributed many clinical trials courses as a speaker and organizing committee member.

slcsen@istanbul.edu.tr

Mr Damien Hong

ICN Member:
Singapore Clinical Research Institution (SCRI)

Contact Person:
Mr. Damien Hong

Further Information

Current Position:
Chief Operating Officer at SCRI

Experience:
As the COO, he is responsible for managing operations strategy and policies, creating value through innovation and aligning employees with corporate goals. He oversees implementation of the strategic direction of SCRI and is involved in day-to-day operations.
He spearheaded the IT infrastructure development which was a key enabler in the highly-publicised CHloroquine for Influenza prevention (CHIP) Trial. Published in Lancet, the Trial received international interest for being the first to utilise the internet to recruit over 1,000 patients efficiently and cost-effectively.
Damien serves as the council member at the Singapore Workforce Development Agency (WDA) Clinical Research Industry Skills and Training Council. He also spearheads various initiatives in SingHealth, in areas including the clinical trial operations/coordination, data management and research technology.

Edwin Chan Shih-Yen, BSc, BVMS (Hons), PhD

ICN Member:
Singapore Clinical Research Institution (SCRI)

Contact Person:
Edwin Chan Shih-Yen, BSc, BVMS (Hons), PhD

Further Information

Current Position:
Chief Scientific Officer at SCRI, Director of Cochrane Singapore, Associate Professor at the Centre for Quantitative Medicine, Office of Clinical Sciences, Duke-National University of Singapore Medical School

Experience:
Edwin Chan is an epidemiologist and Chief Scientific Officer at the Singapore Clinical Research Institute and Associate Professor at the Duke-National University of Singapore Graduate Medical School. He has served as the Director of Cochrane Singapore since its inception. He has previously served as Head of Scientific Management during the set-up phase of the National Registry of Diseases Office and as a trainer & advisor to the Singapore Ministry of Health on clinical practice guidelines (CPG) development. He is currently a member of an Institution Research Ethics Committee, a member of the EBM sub-committee of the National University Hospital Singapore and a GIN-Asia Steering Group member. He has taught many post-graduate research methodology workshops and courses on Clinical Trials, Biostatistics, Epidemiology, CPG development, Meta-analysis & Critical appraisal. His interests are in the teaching of critical appraisal skills and epidemiology, diagnostic test evaluation and decision-making.

edwin.chan@scri.edu.sg

Annette Widmann, MD

ICN Member:
Clinical Trials Center Zurich (CTC), University Hospital Zurich, Switzerland

Contact Person:
Annette Widmann, MD

Further Information

Current Position:
Head of Regulatory Affairs

Experience:
Dr. Widmann has been working as Head of the Regulatory Affairs Unit at the CTC Zurich since 2008. Her team offers competent advice and support in the preparation of clinical trial documents (e.g. study protocol, informed consent and patient information). The CTC Regulatory Affairs Unit experts assist researchers in dealing with ethics committees and regulatory authorities in Switzerland. Submission documents are scrutinised for compliance with regulations and standards (including GCP).
Support can be provided in German, English and French.

annette.widmann@usz.ch

Dr. Andrew Kambugu MBChB, MMed, FRCP

ICN Member:
Infectious Diseases Institute (IDI), Kampala, Uganda

Contact Person:
Dr. Andrew Kambugu MBChB, MMed, FRCP

Further Information

Current Position:
Currently the Executive Director, former Head of Research at IDI Makerere University, College of Health Sciences (MakCHS)

Experience:
Dr. Kambugu is an adjunct Assoc. Prof. at the University of Minnesota, USA and an honorary Senior Lecturer in the Dept. of Medicine MakCHS. He holds a Masters in Internal Medicine from Makerere University, attended infectious diseases specialist training at Universities of Utah and Manitoba; and is a Fellow of the Royal College of Physicians, UK. He is the Chair, Uganda Society for Health Scientists Board and Vice President of the Researchers for Global Health (R4GH) group.
He served as the Prevention, Care and Treatment (PCT) programme lead at IDI for seven years before leading the Research program. He has over 14 years of HIV clinical and programming experience and is a member of two national HIV subcommittees of the Ugandan Ministry of Health. He has made significant research contributions in the areas of antiretroviral therapy and opportunistic infection with over 120 peer-reviewed publications; and is a principal investigator on a CDC-funded national study on task-shifting for antiretroviral therapy.

akambugu@idi.co.ug

Dr. Mohammed Lamorde, MBBS, MRCP, PhD

ICN Member:
Infectious Diseases Institute (IDI), Kampala, Uganda

Contact Person:
Dr. Mohammed Lamorde, MBBS, MRCP, PhD

Further Information

Current Position:
Head of the Prevention, Care and Treatment Programme at the Infectious Diseases Institute.

Experience:
He is an internal medicine physician trained in Nigeria, United Kingdom and the Republic of Ireland. He is a member of the Royal College of Physicians of the United Kingdom.
Over the past nine years, he has worked at IDI undertaking clinical research in the fields of HIV, tuberculosis and malaria; plus health economics evaluations for interventions relevant to public health in developing countries. Dr. Lamorde has also been a clinician facilitator for district-level training in management of medical emergencies and infection prevention and control for emerging infectious diseases.
In 2012, he was awarded a PhD at Trinity College Dublin, Ireland in recognition of his work on the clinical pharmacokinetics of medicines used in the management of HIV-infected adults. He subsequently held post-doctoral positions at IDI including a Sewankambo Post-Doctoral Scholarship focusing on the effect of food on the pharmacokinetics of rilpivirine, and a Senior Fellowship awarded by the European and Developing Countries Clinical Trials Partnership to study drug-drug interactions between rifampicin-based antituberculosis and antimalarial drugs among Ugandan patients with tuberculosis.
Dr. Lamorde is the President of the International Society for Pharmacoeconomics and Outcomes Research Uganda Chapter; and he is a member of the advisory panel of the leading international HIV drug-drug interactions website www.hiv-druginteractions.org and of the African Research Network for Neglected Tropical Diseases.

mlamorde@idi.co.ug

Dr Thomas Hiemstra

ICN Member:
Cambridge Clinical Trials Unit (CCTU), Cambridge University Hospitals NHS Foundation Trust

Contact Person:
Dr. Thomas Hiemstra

Further Information

Current Position:
University Lecturer in Trials at the School of Clinical Medicine of the University of Cambridge; Honorary Consultant Nephrologist

Experience:
Dr Hiemstra is a consultant nephrologist and clinical trialist with particular interests in efficient trials design including adaptive methods, the use of mobile technologies, and the use of routinely collected data sources to capture trial outcomes. Dr Hiemstra leads a portfolio of trials in nephrology and related disease areas, and consults with prospective investigators on behalf of the Cambridge Clinical Trials Unit on trial design.

Prof Dr Heiko von der Leyen, MD

ICN Member:
Hannover Clinical Trial Center (HCTC) , Hannover, Germany

Contact Person:
Prof Dr Heiko von der Leyen, MD

Further Information

Current Position:
Head of the Coordination Center for Clinical Studies at Hannover Medical School (HCTC-KKS)

Experience:
He was co-founder and managing director of Hannover Clinical Trial Center GmbH (HCTC). Prof. von der Leyen was trained in Pharmacology, Internal Medicine, and Cardiology at University of Hamburg, Hannover Medical School. After 3 years of research at Stanford’s Falk Cardiovascular Research Center with focus on cardiovascular gene therapy he was appointed as junior faculty member at the Division of Cardiovascular Medicine of Stanford University from 1995 to 1996. From 1998 to 2005 Prof. von der Leyen served on several top management
positions in the biotechnology industry with focus on the clinical development of advanced therapy medicinal products (tissue engineering, gene therapy, DNA medicine).