Our Mission and Vision
Mission:
HMC CTU is dedicated to promoting, supporting and conducting ethically robust and scientifically rigorous clinical trials. Our mission is to contribute to the advancement of medical knowledge and significantly impact the health and wellbeing of the people in Qatar.
The fulfillment of our mission at the CTU is achieved through the assistance of HMC CTU staff and collaborators who actively promote the adoption of our policies and procedures.
Vision:
To achieve global recognition as a premier center of excellence in designing, delivering and implementing collaborative and innovative clinical trials.
Our Services
The services offered by HMC CTU operate within the framework of the following two service models:
- Assisted Clinical Trial Site: Trial activities are performed by clinicians in their sites with support from CTU on administrative and non-clinical activities.
- Inhouse CTU Trials: Trial activities are carried out in the CTU. The principal Investigator (PI) will have access to both administrative and clinical assistance from specialized study coordinators, nurses and facilities with expertise in clinical trials.
Within the framework of the two service models, we provide an extensive range of services customized to address the varied requirements of our clients in the field of clinical research. Our experienced team can guide you through all phases of the research process, from study design and protocol development to efficient project management. Leveraging state-of-the-art facilities and cutting-edge technology, we offer a platform for pioneering research and innovation. Our support extends to facilitating the conduct of trials and studies through:
- Trial Design Assistance: Collaborative support in designing the clinical trial protocol and methodology. Our preferred model is to partner with investigators early in the design process. This is to facilitate the development of high-quality trials and studies.
- Regulatory Support: Guidance and assistance in navigating regulatory requirements and obtaining necessary approvals.
- Data Management: Services related to data collection, storage and analysis to ensure accuracy and compliance.
- Quality Assurance: Implementation of quality control measures to maintain the integrity and reliability of trial data.
- Training and Education: Provision of training programs for investigators and staff involved in the clinical trial.
- Patient Engagement: Strategies to enhance patient engagement and support throughout the trial process.
- Budget and Financial Management: Assistance in budgeting, financial planning and managing financial aspects of the clinical trial.
- Collaboration with Industry Partners: Facilitation of collaboration with pharmaceutical companies or other industry partners.
- Technology and Infrastructure Support: Access to technological tools and infrastructure necessary for conducting clinical trials.
- Clinical Trial Reporting and Close-down: Services related to data analysis, reporting, dissemination of trial results and close-out activities.
The level of support provided can depend on the nature and scope of each clinical trial. Additionally, we implement systems and procedures to ensure compliance with ethical, regulatory and research governance framework.
Good Clinical Practice
GCP training aims to ensure that:
GCP certified CTU staff.
- The rights, safety and well-being of human subjects are protected.
- Clinical trials are conducted in accordance with approved plans with rigor and integrity.
REDCap Training
Regular hands-on workshops in the use of REDCap (Research Electronics Data Capture)
Abhath Application Training
Hands-on Training for researchers on the Abhath Research Application
Operating Team
- Maintaining CTU workflow including (requests, organization, assessment, inquires management etc.)
- A focal point between CTU and internal/external stakeholders.
- Managing inquiries regarding the CTU and providing guidance.
- Maintain accurate documentation of unit activities for easy retrieval.
- Support quality assurance by ensuring compliance compatibility with SOP and regulations.
- Continuous development and efficiency of the CTU.
- Ensure unit readiness before study commencement.
- Follow up on approvals from the Medical Research Center.
- Resolving Issues.
- Expediting and facilitating processes.
Ultrasound Technician
- Operating imaging equipment.
- Reviewing images to be sure they are of good quality and helpful for diagnosis.
- Identifying normal and abnormal imaging results.
- Communicating a summary of the results to physicians or other health professionals.
- Alerting physicians to urgent problems.
Data Management
- Study Feasibility - data management perspective
- Data management plan - coordination with stakeholders.
- Design and development of data capture systems - REDCap and other platforms..
- User Acceptance Testing (UAT).
- Liaison with external data platform - inter exchange data platforms.
- Data entry and control.
- Quality assurance.
- Facilitating randomization for RCT.
- Export of study data in inter exchange formats.
- Compliance with data regulation - 21CFRpart11, GDIPR, FISMA, MOPH, etc...
- Meeting all standards.
Echo Technician
- Creating images of the heart.
- Cardiac chambers, valves and vessels for the purpose of assessing heart function and diagnosing heart ailments.
Lab Technician
- Specimen processing (blood, stool, saliva)
- Serum/plasma separation
- Aliquoting
- Processing via refrigerated centrifuge and microcentrifuge
- Whole blood without processing (no centrifugation)
- Urine or 24-hour urine collection
- Buffy coat separation
- Short term storage in -80 degrees C freezer, -20 degrees C freezer, and/or small incubator
- Labelling, shipping and handling
- All samples can be processed in HBK (Main lab).
Investigational Pharmacy
- Importing license
- Ensure effective and safe management of investigational medicinal products.
- Providing support in study protocol reviewing.
- Patient education.
- Patient counseling.
- Drug information.
- Patient compliance monitoring.
- Safe investigational drug dispensing.
- Supply of investigational product.
- Investigational product accountability.
- Obtain history, review of systems, medication reconciliation and perform physical exams and clinical assessments.
- Follow up and maintain medical equipment.
- Screen participants and obtain consent.
- Assist with clinical management (i.e. management of AEs and SAEs)
- Common clinical procedures.
- Vital signs, height, weight, BSA.
- Blood draws via direct venipuncture, peripheral IV and including serial blood sampling for PK and PD samples.
- Blood glucose via finger stick.
- Urine pregnancy test.
- Body fluid collections (buccal swab, urine, stool, or sputum).
- Administration of medications and investigational drugs/products.
- Routes include oral, topical, intramuscular and subcutaneous injections, intravenous, inhalation).
- Chemotherapy (routes include oral, inhalation, SQ and IV infusions).
- Administration of IV fluids.
- Cardiac assessments.
- Single, triplicate, serial 12- lead ECG (no interpretation).
- Holter monitoring and telemonitoring.
- CTU Body composition services.
- DEXA scan of whole-body composition, hip, and/or spine.
- Waist-hip circumference.
- Skin fold measurement (per site).
- Patient observation.