​ THE PRACTICE OF CLINICAL RESEARCH MEDICINE

Clinical research is essential for developing new treatments; supporting evidence based clinical practice, improving patients' outcome and quality of life, as well as guiding policymaking. It involves research and/or experimentation on human beings, the use of personal health information, and, at times exposing individuals to risk, while maintaining the highest standards of ethics and the law.

Most industry and academic sponsors hav​e embraced the internationalization of clinical research. This trend has seen a rapid growth in various geographic regions. The globalization of clinical research/trials in such a rapidly changing environment is primarily due to the promises of new technologies and therapies. However, the challenge is using these resources safely, efficiently, and wisely.

Many countries have seized such opportunities not only to support their healthcare systems by using clinical research data and evidence, they have also used clinical research/trials to gain early access to and take part in the evaluation of emerging therapies and technologies prior to their adoption. Research Investigators and University Medical Centers have also benefitted from clinical trials/research both scientifically through scientific advancement, and financially from industry sponsored research.

The field of clinical research continues to receive considerable attention, and many healthcare professionals wish to explore the excitement of participating in clinical trials/research and training opportunities. This has led to the emergence of a new branch of medical science; 'clinical research medicine', defined as the science of planning, designing, conducting and interpreting clinical trials/ research.

The Arabian Gulf University (AGU) has identified and set the practice of clinical research medicine as one of its main priorities in its current strategic development. The goal is to promote, encourage and support quality clinical research practices in the GCC region, and internationally. Thus ensuring that the Kingdom of Bahrain as well as GCC states become important hubs for quality clinical trials.

Vision:

To become the most reliable and trusted professional clinical research group in the GCC region, and achieve premier status working collaboratively and effectively as researchers and clinicians in order to advance scientific knowledge and clinical care.

Mission:

lness of our population through excellence in clinical research medicine.

Objectives:

• To become a recognized regional center of excellence in clinical research, and address disease and wellness issues more specific to the GCC population;
• To develop clinical research activities, and provide clinical research management support;
• To provide training to healthcare professionals as part of its course offerings; and
• To contribute to strengthening of current rules and regulations in the GCC region.

Philosophy:

• To foster a uniquely collaborative and collegial environment that emphasizes respect, trust and personal growth;
• To champion flexible and adaptable solutions, through creative thinking, innovation and integrity;
• To ensure respect, confidentiality and absolute safety of patients as research subjects;
• To ensure compliance with international and local standards & regulations
• To promote viable and genuine with clinicians-investigators, patients, staff, and the industry as a whole
• To work as a true teams of scientists, clinicians, staff and administrators to promote an open, inclusive, diverse and supportive workplace that stresses the value of the individual while celebrating the accomplishments of the whole; and
• To exceed expectations through the combination of dedication, work, perseverance, rigor along with the highest standards of ethics, without compromise.

AGU's CLINICAL RESEARCH CENTER CAPABILITIES:

Technology Enabled Services for Clinical Trials Sponsors:

• Medical affairs and regulatory management support
• Project/site management
• Medical writing and document management
• Study monitoring (clinical and medical)
• Accredited Central laboratory services (Al Jawhara Center)
• Clinical trials operations management
• Safety management
• Investigators support (research nurse coordinators)
• Data management, statistical support and MeDRA coding
• State of the art EDC, CTMS and eTMF solutions (IP supply and IWRS)

Support Services to Medical Centers and Healthcare Institutions:

• Strengthen the ethical review process and help improve research ethics committees operations
• Support the development of institutional research policies and GCP compliant standard operating procedures (SOPs)
• Provide clinical research training for clinicians and staff on institutions
• Create a model clinical research/trial unit and assess effectiveness and performance
• Support investigators in developing clinical research projects from conception, through operation, to publication

Competencies and Expertise:

• Leadership role in clinical research development in the GCC and MENA regions with extensive US and European experiences in the clinical development of drugs, devices and combination products (Phase I-IV)
• Hands-on management of small, medium and large scale local, regional and International clinical trials
• Experienced clinical research monitors, clinical data managers and trials coordinators
• Broad spectrum of specialties including, oncology, hematology, cardiology, rheumatology and neurology among others
• Multiple successful regulatory filings with the US FDA (IND/NDA, IDE/PMA)

Clinical Research Training:

The practice of clinical research/trials is a routine practice at leading university medical centers and healthcare institutions worldwide. However, institutions that utilize, produce, study, invest in, or conduct research in pharmaceuticals, stem cells or biotechnology products, medical devices, or other type of health care interventions, command a sound understanding of the science and operations of clinical trials/research, the ethical and regulatory considerations, and possess sets of skills and competencies that are different from those acquired in most medical schools where clinical research is a marginal subject in undergraduate medical training programs.

AGU's Clinical Research Center in collaboration with the University of Maryland offers the following training and workshops programs intended for clinicians-investigators, clinical research nurses and research support staff, ethics committees, and industry clinical research professionals:

• Clinical Research Medicine Diploma (2017)
• Series of Workshops on:
  • Clinical Research Ethics
  • Good Clinical Practices
  • Clinical Trials Regulatory Requirements in GCC