Members

Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust

The Cambridge Clinical Trials Unit (CCTU) was established in 2011 to lead studies that translate the extensive scientific advances provided by Cambridge Science into clinical application. CCTU is a fully registered CTU and is hosted at the Cambridge University Hospitals NHS Foundation Trust (CUH) as part of the Cambridge Biomedical Research Centre (BRC). It aims to drive the design and delivery of pioneering translational studies to the highest international quality through interaction/collaboration with basic scientists, the NHS, BRC and Industry Partners.

The CCTU collaborates with investigators in the conduct of Drug trials (Clinical Trials of Investigational Medicinal Products – CTIMPs), Medical device trials, Mechanistic and physiological research studies, Observational studies and Qualitative research. We are committed to developing, and applying innovative clinical trial methodologies, to make trials more efficient and to provide better-informed and earlier go-no-go decisions.

Its objective is to be at the forefront of design and development of novel early phase/experimental studies to support our translational objective. To increase trial efficiency we continue to develop our expertise in electronic health records, disease registries, routine data sources and patient self-reports.

It assists trial teams and investigators with grant proposals, including those for NIHR and Wellcome Trust calls. Our portfolio ranges from single-centre to multi-centre, national to international, phase II to phase IV drug trials, as well as other randomised control trials and well-designed studies. The CCTU also provides quality assurance, as delegated by sponsors, for routine monitoring and central trial oversight.

Clinical Trials Centre, The University of Hong Kong

Hong Kong, China		Clinical Trials Centre, The University of Hong Kong		Representative at ICN: Henry Yau, Managing Director

Homepage: https://www.hkuctc.com/
LinkedIn: https://www.linkedin.com/company/hkuctc
Facebook: https://www.facebook.com/hkuctc

HKU-CTC is an academic clinical research organization established under HKU in 1998, and has been authorized as the central platform for management and coordination of clinical studies under HKU and its affiliated teaching hospital – QMH (Queen Mary Hospital). HKU-CTC is devoted to partnering with clinical investigators, research organizations and the healthcare industry in advancing human healthcare by attracting and facilitating clinical research and safeguarding the core principles of volunteer protection, scientific validity and data integrity. Types of clinical studies coordinated by HKU-CTC include:

investigator-initiated and industry-sponsored clinical studies;
interventional and non-interventional clinical studies;
phase 1 to 4 clinical drug trials, bioequivalence studies and clinical pharmacology studies;
clinical studies on other medical/medicinal products such as medical devices, diagnostics, traditional/proprietary Chinese medicines, alternative medicines and health supplements; and
clinical studies on clinical procedures and methods.

Over the years, HKU-CTC has developed into a leading, full-service professional organization capable of offering comprehensive SMO (Site Management Organization) services, CRO (Contract Research Organization) services and phase 1/pharmacokinetics services in support of clinical research. From the initiation of a clinical study to its close, HKU-CTC is able to provide tailored solutions to its partners and clients.

Since its establishment, HKU-CTC has already facilitated over 1,200 industry-sponsored clinical studies in collaboration with more than 300 sponsors around the world. For the moment, over 220 investigator-initiated studies and 350 industry-sponsored studies are ongoing.

To sustain its expanding activities, HKU-CTC adopts the principle of TQM (total quality management) throughout the entire organization and gains recognition by the industry and regulatory authorities, including accreditation by the China NMPA (National Medical Products Administration) since 2006. Being a leading academic research organization, HKU-CTC also spares no effort in involving in educational and knowledge exchange activities. In particular, a unique and comprehensive training programme on GCP and clincial study management – namely PRACTISE® – was specifically designed for investigators, study coordinators and study site personnel worldwide, and training workshops based on this programme have already been conducted in Asian, Middle Eastern and North African regions since 2012.

Muenchner Studienzentrum, Technical University Munich, School of Medicine

Munich, Germany		Muenchner Studienzentrum, Technical University Munich, School of Medicine		Representative at ICN: Dr med Christiane Blankenstein, Director

Homepage: https://www.kks-netzwerk.de/netzwerk/ueber-uns/mitglieder/mszmuenchen.html
Facebook: https://www.facebook.com/KlinikumrechtsderIsar/

Muenchner Studienzentrum (MSZ) is an academic clinical research organisation which was founded in 2001 as a core facility of Technical University Munich (TUM), School of Medicine. Our goal is to develop and support clinical studies and to assure high quality in patient-oriented, clinical research according to ethical and ICH-GCP standards. Within our complete set of services we provide professional assistance ín comprehensive planning, coordination, management, and reporting of clinical projects. Whereas our main focus lies on academic collaborations, services are also offered to industry partners. Our project portfolio covers prospective clinical study designs for single-/ multi-center, national/ international projects in different indications, scientific topics and phases of development. General support is provided ranging fom business development activities (e.g research consultation, financial planning and grant application) to (risk-based) quality management, quality assurance (monitoring, auditing), data management/IT, biostatistics and safety management in line with regulatory requirements. We offer basic and advanced training and education to investigators, study assistants and further study personnel aiming to provide a solid basis for the conduct of clinical research.

Challenges like the ongoing Covid-19 pandemic demand new approaches to enable study progress on the one hand and high safety standards for study participants on the other hand. In line with the goal of our organisation we provide prompt and tight consultation, support- and solution-oriented strategies to advance projects.

The MSZ collaborates with various academic partners and networks on a regional, national (e.g. the German network “Coordination Centers of Clinical Studies”, KKSN), or European (i.e. European Clinical Research Infrastructures Network “ECRIN”) level.

In particular, the MSZ is proud to be a founding and active member of the international clinical trial network “ICN”. International collaborations like the ICN strengthen and build alliances to improve clinical research and facilitate processes on an international level. ICN promotes the conduct of international clinical studies according to required ethical and regulatory standards.

Clinical Trial Center, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo – Dipartimento Attività Integrate Ricerca Innovazione (DAIRI)

Representative at ICN:
Dr Marta Betti, Head of Clinical Trial Center

LinkedIn: https://it.linkedin.com/company/aoalessandria
Twitter: https://twitter.com/aziendaospal
YouTube: https://youtube.com/channel/UCU9FkJ4IE-iJ_f1Qi3XnCMw
Facebook: https://www.facebook.com/aoalessandria
Instagram: https://instagram.com/aoalessandria

Established in 2013, the Clinical Trial Center (CTC) of the Research and Innovation Department (DAIRI, Director Dr Antonio Maconi) is a centralized sector working within both the Public Hospital “SS Antonio e Biagio e Cesare Arrigo” of Alessandria (AO AL, Italy) and the Local Health Authority of Alessandria (ASL AL).

The CTC is focused on designing and conducting high-quality clinical trials: it promotes efficiency during the study activation phase and optimizes study and data management according to the International Standards of Good Clinical Practice (ICH-GCP).

The CTC is the designated interface for Sponsors and Contact Research Organizations (CROs) that recognize DAIRI as their partner for testing innovative therapeutic strategies in an effort to offer patients the best quality healthcare available.

The CTC’s vision is to be an attractive Centre for clinical research and the mission is to improve the populations’ health through ethical and quality research. The core values are: we are strong when working as a team; we have all stakeholders at heart, we work according to international Good Clinical Practice Standards (ICH-GCP), we pay more attention to the centrality of the patient, we optimize processes using lean thinking.

The CTC works in close collaboration with the Biological Materials Collection Centre, which includes a Biorepository for the temporary storage of biological specimens for clinical trials, and with the DAIRI’s Administrative Coordination for negotiating agreement and authorizations.

Activities include:

Feasibility and study start-up
Clinical trials design and management (profit and no-profit, interventional (II-III-IV phases), observational and on medical devices clinical trials)
Clinical research census and monitoring
Education and training

CTC’s staff consist mainly in research coordinators and data managers, usually organized according to therapeutic areas (solid tumors and blood cancers, gastrointestinal diseases, infectious diseases, nervous system diseases, cardiovascular diseases, musculoskeletal and connective tissue diseases, and metabolism and nutritional disorders).

The CTC is unique in the Piedmont Region for the centralization of its activities and staff.

Centre for Clinical Trials Essen

Homepage: https://www.zkse.de/

The Centre for Clinical Trials Essen (ZKSE) is a unit of the Faculty of Medicine of the University Duisburg-Essen. The ZKSE offers individual, competent and qualified advice and support covering the full spectrum of patient-oriented clinical research, including drug trials before and after approval, studies on non-drug therapies and medicinal products, diagnostic and prognostic studies, and epidemiological studies including non-investigational studies (NIS). Our interdisciplinary team consists of scientists, statisticians, computer scientists, lawyers and physicians as well as trained data managers and our support includes all phases of a study from design, implementation, and quality assurance to evaluation and reporting. Full service packages as well as specific services are offered.

During study planning, the experienced staff of the ZKSE assists in statistical planning and offers support in coordination with ethics committees and authorities. In addition, we prepare study plans and statistical analysis plans. During the ongoing study, trained monitors check compliance with GCP requirements, the Declaration of Helsinki and the relevant laws and regulations and are available to the study team with their medical knowledge as competent contacts. Another field of activity of the ZKSE is data management, which is responsible for the generation of high-quality and valid data as a prerequisite for successful evaluation.

ZKSE offers support in the planning and preparation of both paper-based and electronic study report forms (CRFs) and appropriate training of the study teams. In addition, the ZKSE has qualified staff in the field of pharmacovigilance who, if required, can, for example, take over the legally required reporting of adverse drug reactions to the competent drug authority.By handling the project management, our interdisciplinary team can support study leaders in the successful execution of their study. For the further course of the study, the ZKSE has qualified personnel who are responsible for the statistical evaluation and the preparation of the final report according to ICH-E3. Finally, the tasks of the ZKSE also include the further education and training of investigators and assistant staff on the methodology of clinical studies and the underlying regulations (ICH-GCP, AMG, MPG).

The ZKSE was founded in 2006 as part of the Institute of Medical Informatics, Biometry and Epidemiology (IMIBE). As a university institution, it is our primary ambition to further develop clinical research in the existing scientific environment by improving prophylactic, therapeutic and diagnostic procedures and gaining new insights into the aetiology and pathogenesis of diseases. Over the last 10 years, the ZKSE has proven expertise in many investigator-initiated trials as well as trials of the pharmaceutical industry including international, multilingual projects.

Medical University of Graz

Graz, Austria		Medical University of Graz		Representative at ICN: Dr. Carolin Auer, Head of Research Management
© Graz Tourismus – Harry Schiffer

Homepage: https://www.medunigraz.at/en/
Facebook: https://www.facebook.com/medunigraz
Instagram: https://www.instagram.com/medunigraz/
Twitter: https://twitter.com/MedUniGraz
LinkedIn: https://www.linkedin.com/school/medunigraz
YouTube: https://www.youtube.com/c/MedizinischeUniversitätGraz

At Medical University of Graz, The Clinical Trials Unit (CTU) is a fully equipped clinical research facility that supports researchers of the Medical University of Graz and industrial partners in the realisation and conductance of clinical trial projects according to their needs.

The experienced and dedicated staff efficiently plans and conducts clinical trials in accordance with the Declaration of Helsinki, international Good Clinical Practice Standards (ICH-GCP), legal requirements and the highest safety and quality standards. The CTU is ISO 9001:2015 certified and has particular expertise in phase-I-trials.

The CTU supports academic and investigator-initiated clinical research but is also open to clinical trials sponsored by the industry.

Infrastructure:

250 m² research dedicated area at the CF-CTU
12 treatment places
8 hospital beds on intermediate care level
Processing laboratory
Temperature controlled drug storage and retention areas
100% research dedicated staff at the CF-CTU
Risk Management System
Clinical Trial Management System
Quality Management System
100% research dedicated staff at the CF-CTU, multidisciplinary team: medical doctors, study nurses, project managers, quality managers, monitors/auditors, biochemists, laboratory staff, care attendants, office staff, study co-workers
GCP and first aid (basic life support) trained, re-trainings on regular basis included
ISO 9001:2015 certification
Database: trials, subjects, inventory, staff, courses

The Coordination Center for Clinical Trials (KKS) is a service center for all researchers of the Medical University of Graz with a focus on Investigator Initiated Studies. The KKS provides consultation and support in the planning and project management of clinical trials and offers the following services:

Consultations for all researchers in all fields of Clinical Studies
Submission to ethics committee and competent authorities
Project Management before, during and after conducting a Clinical Study
Inhouse GCP trainings for researchers
Inhouse refresher trainings for the university courses” Clinical investigator” and “Clinical trial specialist”
Feasibility Assessment
User of the EudraVigilance Database, safety management
Site initiation visits, Regular monitoring visits and Close out visits
Preparation and review of study documents and review of study protocols
Coordination of the contract management
Coordination of the study drug management
Quality- and Risk management, ISO 9001:2015 certification

Infectious Diseases Institute

Kampala, Uganda		Infectious Diseases Institute		Representative at ICN: Dr Andrew Kambugu The Sande-McKinnell Executive Director

Homepage: https://idi.mak.ac.ug/
Twitter – https://twitter.com/IDIMakerere
Facebook – https://web.facebook.com/IDIMakerereUniversity/
Instagram – https://www.instagram.com/idimakerere/
Youtube – https://www.youtube.com/channel/UCfuL5T5KK54jOhZYNWDsC3g
LinkedIn – https://www.linkedin.com/company/infectious-diseases-institute-idi-/

IDI was established in 2002 by the Academic Alliance for AIDS Care and Prevention in Africa, a group of infectious diseases experts from Uganda and North America. It is a Ugandan not-for-profit organisation, established within and wholly owned by Makerere University, whose mission is “to strengthen health systems in Africa, with a strong emphasis on infectious diseases, through research and capacity development”. IDI is a national and regional centre of excellence in infectious diseases programming. IDI has strong links with the Ministry of Health (MoH) through its long term support of facilities in the districts, Regional Referral Hospitals, and headquarters functions; contribution to technical working groups; and national referral system. IDI has six operational programmes supported by robust finance and administrative systems;

Prevention, Care and Treatment: IDI is a national referral centre providing specialized HIV care and treatment services including second line and salvage therapies, for over 7,000 patients with support from CDC and the Government of Uganda.
Training: IDI is an accredited continuing professional development (CPD) provider for health workers in infectious diseases and systems strengthening. The department provides systematic ongoing distance support, eHealth approaches (including online training) and a free real time call in service.
Research: Responsible for over 80 current projects and research facilities including the Clinical Trials Unit, Data Management and Statistics; Research Administration and the African Centre of Excellence in Bioinformatics and Data Science (ACE). IDI supports formal courses in basic and advanced clinical research skills, epidemiology, biostatistics, data management, research methods and Good Clinical Practice.
Laboratory Services: A state-of-the-art laboratory certified with the College of American Pathologists, provides high quality, internationally accredited services including an important QA/QC role for service providers and researchers; and manages a translational lab.
Global Health Security: Supports implementation of the Global Health Security Agenda by the Ministry of Health in three strategic areas; Laboratory, Epidemiology and Informatics, Infection Prevention and Control (IPC) and Case Management and Medical Countermeasures.
Health Systems Strengthening: Lead CDC PEPFAR implementing partner in Kampala, Mid-Western and West Nile regions, which together with MoH and other stakeholders provides care and treatment services to over 320,000 PLHIV in urban and rural Uganda. IDI is the lead USAID TB Implementing partner in nine districts in Karamoja region; and offers technical support in emerging and re-emerging infectious disease programming and financing in 60% of districts in Uganda.

The Sande-McKinnell Knowledge Centre – IDI Headquarters at Makerere University

Clinical Trial Center, China Medical University Hospital

Taichung, Taiwan		Clinical Trial Center, China Medical University Hospital		Representative at ICN: Dr. Li-Yuan Bai, Deputy Director

Homepage: http://www.cmuhctc.tw/
Facebook: https://www.facebook.com/cmuhctc/

China Medical University Hospital has built a Clinical Trial Center of high quality and high efficiency in conducting clinical trials with well-equipped clinical trial soft- and hard-wares staffed with an outstanding team of clinical trial professionals. All the equipment and procedures have received international certifications at the highest level, including ISO27001, CAP, AAHRPP, JCI, FERCAP. The CTC is in full collaboration with other research institutes including Academia Sinica, National Health Research Institute, and multinational and domestic pharmaceutical and biotech companies. A successful late-phase clinical trial is the last milestone to advance a novel drug or a medical device into the market. We have signed contracts for collaboration in clinical trials with more than 350 companies, CROs, and research institutes including the top 25 multinational pharmaceutical companies of the world since the CTC had established in 2010. The CTC is unique in its innovative design of clinical trial processes featuring a single-window, one-stream, and full-phase operation design, covering the entire trial procedures. Another unique advantage of the CTC is its establishment of the nation-first Academic CRO (ARO). The ARO has the superior strength of facilitating the execution of any clinical trial at top speed with high efficiency and much lower costs than commercial CROs. The other advantage is In-house SMO, which provides expert support for trial subject recruitment and trial procedure execution. There is a highly valuable set-up to build Real-World Evidence based on big health data analytics. The team with 6 full-time biostatisticians has assisted healthcare professionals in publishing more than 1,800 papers in SCI journals, including those at a very high ranking, such as Lancet and JAMA. The ability to explore Real-World Evidence based on available big health databases including the National Health Insurance Record Database, Taiwan Stroke Registry, and others, confer the unique expertise to assist in a large number of clinical trial tasks including feasibility surveys, sample size estimation, protocol design, interim analysis, and endpoint assessment. Overall, the CMUH-CTC has reached top-notch expertise in clinical trials and is capable of executing the most demanding tasks in clinical trials. The CTC has been invited to join the largest clinical trial organization in the world, Society for Clinical Research Site (SCRS), with the CTC PI assigned the title of SCRS Ambassador in Taiwan. The CTC is also a lead member in Taiwan in the International Clinical Trial Center Network (ICN), established by world-renowned clinical trial centers including Harvard and Cambridge.

CMUH-CTC has been conducting a large number of clinical trials. Our mission is to provide high-quality and comprehensive clinical trials to valid innovative new drugs and medical devices to be approved by TFDA and FDA for advancing therapeutic to improve the safety and efficacy of treating patients in Taiwan.

ISM Clinical Trial Center

Yaoundé, Cameroon		ISM Clinical Trial Center		Representative at ICN: Prof. Joseph Kamgno CEO ISM Clinical Trial Center

Homepage: https://ismcm.org/
Facebook – https://m.facebook.com/people/ISM-Cameroon/100093272173195/
LinkedIn – https://www.linkedin.com/company/institut-superieur-de-recherche-scientifique-et-medicale-/

ISM Clinical Trial Center is a Research Unit of the Department of Epidemiology and Clinical Research at the Higher Institute for Scientific and Medical Research (ISM), formerly known as the Centre for Research on Filariasis and other Tropical Diseases (CRFilMT), which is a Cameroonian not-for-profit association working in the field of medical research. ISM was created in 2005 by Joseph KAMGNO, Professor of Epidemiology and Head of the Department of Public Health at the Faculty of Medicine and Biomedical Sciences (FMSB) of the University of Yaoundé I, to put biomedical research at the service of the control of tropical diseases.

ISM Clinical Trial Center was officially set up in 2019, and aims to:

Contribute to the development of drugs for the treatment of infectious diseases in the context of Africa;
Train local team and students within the continent for the development of drugs to contribute to the fight again diseases and particularly infectious diseases endemic in the Region.

Indeed, Africa is in need for appropriate drugs or treatment regimen for the control/elimination of Infectious Diseases, especially Neglected Tropical Diseases (NTDs). However, Clinical Trial Centers are not so common in the Region, and early stages of drug development that will be used only in Africa are carried out outside the continent, although the dietary habits and specific physiology of Africa’s black populations. It therefore appears more appropriate to carry out such early stage of drug development in Africa to make sure the pharmacokinetic and the metabolism is optimally assessed and understood in the Africa local populations. It is in this context that ISM Clinical Trial Center was established as a response to this pressing need.

ISM main goal is to (i) Contribute to the control and elimination of infectious diseases by fundamental and applied scientific research; (ii) train the health personnel and students from Africa and all over the world; (iii) provide quality training to health personnel in the surveillance, prevention and management of drug adverse events, (vi) conduct research activities on infectious diseases, in particular neglected tropical diseases (NTDs).

ISM benefits from a collaboration agreement with Cameroon’s Ministry of Public Health (MINSANTE) to improve decision-making based on research evidence. ISM has thus been able to map the distribution of neglected tropical diseases (in particular filarial infections) in Cameroon, enabling the Ministry of Public Health to implement interventions to fight against these diseases.

Information on the mission /values

ISM was created to contribute to fill the gap in terms of research and training in Sub-Saharan Africa. Many strategies have been tested, with limited success, in this part of the world to fight against tropical diseases and thus alleviating associated poverty, misery and suffering. The development of targeted research and quality training appear as a solution, and ISM has been established to improve the research environment in order to guide and give hope to the young generations of Africans, with equity in human development as main value.

Information on the available / offered services

ISM conducts epidemiological studies in support of the Ministries of Health activities, including the mapping of infectious diseases as well as monitoring and evaluation activities (drug coverage, impact assessments …) in Cameroon and in Central Africa for evidence-based decision making. ISM has been established as one of the four reference laboratories across Africa for the elimination of Neglected Tropical Diseases. As such, samples from various Sub-Saharan African countries are processed (Immunology and Molecular Biology) and results communicated to countries for actions. ISM teams also work on diagnostic tool development and evaluations. In term of infrastructure, ISM is also equipped with a Medical Centre for General Medicine and specialized consultation, a clinical laboratory to provide sample processing service, a meeting rooms and an Amphitheater of about 200 sits for meetings and teaching, as well as a Clinical Trial Centre made up of an investigation room with capacity of 12 beds, a nurse room to watch patients, and all the logistics with the resuscitation room, the sampling rooms, the garbage room, the pharmacy.

The types and number of supported trials

ISM teams have already conducted more than 10 clinical trials of phase II and III, essentially for the development of optimal treatment regimen for filarial infections. Most of these trials were conducted in the field, directly in communities where onchocerciasis and loiasis are endemic. Patients were screened, recruited, treated and followed in the field. These trials were conducted before the setup of ISM Clinical Trial Centre.

References to certificates and awards

Since its inception in 2005, ISM enters a collaboration agreement with the Cameroon Ministry of Public Health and less than 5 years later (2009), ISM received a testimony of Satisfaction from the Cameroon Ministry of Public Health. In 2015, ISM received the Islamic Development Bank Price for Science and Technology (US$ 100 000) in recognition of its contribution to the social and economic Development of Cameroon.
In 2020, ISM Research Scientists (Hugues C. Nana Djeunga and Arnauld Efon Ekangouo) received the first prize of the NTD Innovation Award supported by the American Leprosy Missions and Novartis for their research on the development of circulating cell free DNA biomarkers for the diagnosis of onchocerciasis. In 2022, Joseph Kamgno, the CEO of ISM, received the Christophe Mérieux Price (€ 500 000). In addition to these prizes and awards, ISM staff are members of various national and international boards, Committees and Scientific Societies, including (but not limited to) Cameroon Academy of Sciences (CAS), Cameroon Academy of Young Scientists (CAYS), African Academy of Science (AAS), Global Young Academy (GYA), African Research Network for Neglected Tropical Diseases (ARNTD), Cameroon Onchocerciasis Elimination Committee, World Health Organization (WHO) Onchocerciasis Sub-Group (OTS), WHO expanded Diagnostic Technical Advisory Group (DTAG), Royal Society of Tropical Medicine and Hygiene (RSTMH), American Society of Tropical Medicine and Hygiene (ASTMH) …

Higher Institute for Scientific and Medical Research

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ICN – International Clinical Trial Center Network

Steering Board Members

Regular Members

Affiliated Members

Zurich, Switzerland		Representative at ICN: Dr med Regina Grossmann, Head

Adelaide, Australia		University of South Australia		Representative at ICN: Professor Alison Coates, Dean: Research

Aga Khan University

Kuala Lumpur, Malaysia		Clinical Investigation Centre		Representative at ICN: Krisna Veni Balakrishnan