Research Capabilities at CRTMCD
Continuous Training
At CRTMCD, we understand the importance of continuous training and staying updated in the field of clinical research and across various health sectors. Routine in-house workshops on protocol compliance, adverse event (AE) reporting, data integrity and patient safety are part of our commitment to improving performance and ensuring patient well-being. As an organization, we emphasize the need for continuous safety reporting training and have the capacity to organize extensive workshops and seminars to keep our team and collaborators well-prepared. Through our partnerships and collaborations, we have also been able to offer continuous medical education (CMEs) in various institutions, ensuring meaningful capacity building and knowledge sharing. Our dedication to continuous training has allowed us to remain dynamic and adaptable while consistently delivering high-quality research.
THIS COMMITMENT reflects our drive to not only meet but exceed sponsor expectations while supporting transformative health outcomes for the communities we serve.
Robust Research Infrastructure
Modern Clinical Facilities
Dedicated Outpatient and Inpatient Units: Our site is equipped with state-of-the-art patient monitoring systems, electrocardiogram (ECG) machines, ultrasound scanners and telemedicine interfaces for remote consultations ensuring that we are well-equipped to tackle complex challenges both inside and outside the wards. We are committed to improving health outcomes with specialists available to support our work and patients. The outpatient department is staffed with dedicated resident medical doctors and nurses who are capable of managing the wide variety of diseases we encounter on a daily basis. For patients requiring hospitalization and monitoring, our inpatient wards offer the necessary care and support. Our on-call specialists bring passion and commitment to improving patient outcomes and enhancing the quality of life for those under our care.
THIS ROBUST INFRASTRUCTURE ensures that we provide comprehensive care while supporting the needs of complex clinical trials, all aimed at achieving better health outcomes for participants and contributing valuable insights to the research community.
Emergency Preparedness
Our clinical trial site is staffed with certified medical professionals skilled in Advanced Cardiac Life Support (ACLS) and Basic Life Support (BLS) ensuring patient safety throughout all trial phases. In partnership with our host hospital, we maintain a well-stocked emergency room equipped with the necessary drugs and equipment to address any emergencies. The emergency room is conveniently located near the site clinic, providing quick access to care when needed. In collaboration with Mary Help Mission Hospital, we have direct access to an ambulance for emergency cases requiring transportation from home to the hospital or for hospital transfers when referrals are necessary. The ambulance is fully equipped with an emergency cabinet and monitoring equipment to ensure patient stability during transit.
WE ALSO PRIORITIZE ongoing training in emergency response. Regular retraining sessions ensure that our medical staff stay up to date with the latest protocols and best practices guaranteeing that we are always prepared for any situation.
Cutting-Edge Laboratory Network
Central Lab (Thika)
Our Central Lab in Thika is fully equipped to support a wide range of diagnostic services including microbiology, immunology (flow cytometry, ELISA), molecular diagnostics (PCR, RT-PCR) and specialized biomarker assays. The lab is managed by highly qualified personnel who have been trained across various sectors including handling dangerous goods, ensuring safety and precision in all procedures. Through our collaboration with the Center for Malaria Elimination Lab, we have access to specialized equipment such as -80°C and -70°C freezers, which are critical for preserving sensitive biological samples. The laboratory is equipped with cutting- edge technology enabling us to handle complex analyses and research programs with confidence. We also have a team of qualified medical lab technicians and research scientists trained to carry out both scientific and clinical analyses with the highest level of expertise. Our collaborations with institutions like KEMRI, KAVI, Nagasaki University and international partners have opened doors for further analysis and have positioned us to make a significant impact on the scientific community.
THIS COLLABORATIVE APPROACH not only enhances our research capacity but also strengthens our ability to contribute valuable insights to global health challenges particularly in the fields of infectious diseases.
Satellite Labs (Bungoma)
Our Satellite Lab in Bungoma is designed for patient testing, quick specimen processing and maintaining cold-chain standards (+4°C, -20°C) while transferring samples. Serving the western region, this lab has been instrumental in improving clinical outcomes for the people of Bungoma making a real difference in addressing the area's most pressing health challenges. The lab’s success has also opened doors for valuable collaborations with other partners bringing in even more advanced services to the area. By working together, we're aiming to alleviate the leading health problems and improve outcomes for the community.
THE FACILITY is fully equipped with qualified personnel and is part of a hospital institution making it easily accessible and well-positioned to carry out clinical trials. This ensures we’re not only meeting local needs but also contributing to broader research efforts in the region.
SOP-Driven Pharmacy & IMP Management
Good Distribution Practice (GDP) for managing investigational products such as temperature-controlled storage and real-time monitoring systems. The site pharmacy is equipped with modern day medical refrigerator as well as storage rooms for non-refrigerated pharmaceuticals. The systems in place enable continuous temperature monitoring, assuring proper medicine storage and reducing temperature excursions. The site employs experienced and knowledgeable individuals who have been trained in Good Clinical Practice and the handling of Investigational Medical Products.
THERE ARE DEDICATED PHARMACISTS that specialize in protocol-specific dispensing, inventory control, drug accountability, and compliance reporting.
Advanced Data Management & Biostatistics
Electronic Data Capture (EDC) platforms ensure real-time data validation, minimized errors, and robust audit trails. The systems in place allow application of web-based systems to capture data. Strong and available internet to ensure international standards of data collection and storage. Ample storage space designed to archive documents and maintain them in proper conditions without damage. Authority only spaces to ensure confidentiality of participants information. Qualified personnel trained on data collection and statistical method of analyzing information.
BIOSTATISTICIANS proficient in adaptive trial designs, survival analyses, and multi-center data integration. They ensure quality data and proper documentation.
Efficiency, Compliance & Quality Assurance
Regulatory Mastery
Comprehensive support for ethics submissions and approvals from the Pharmacy and Poisons Board (PPB) and Institutional Review Boards (IRBs) such as Mount Kenya University Ethics Committee in Thika and Jaramogi Oginga Referral Hospital Ethics Committee in Kisumu, expediting study start-up timelines.
IT IS OUR PRIME RESPONSIBILITY to ensure ethically driven research and studies. Safety and quality data is very key to CRTMCD.
ICH-GCP Aligned Quality Management
Ongoing internal audits, risk-based monitoring, and standard operating procedures (SOPs) to ensure data accuracy, patient safety, and protocol fidelity 22. We have enforced quality and regular training of all the members associated with the site to ensure competent and professional staff.
WE ENSURE HIGH-VALUE OPERATIONS on-site that meet the required standards.
Continuous Quality Improvement (CQI)
Metrics-driven approach to identify performance gaps, implement corrective actions, and optimize enrollment rates and retention. Staff support and welfare are key to the organization.
WE ENGAGE IN TEAM-BUILDING ACTIVITIES to bring people together and reenergize for future prosperity.
Exemplary Track Record
Phase I–IV Clinical Trials
At CRTMCD, we have the capacity to successfully conduct phases I-IV clinical trials. Our facility is designed to accommodate site staff comfortably. Our clinic flow ensures patients are seen efficiently and in a manner that supports an accommodating experience. We take pride in having immaculate and professional medical personnel capable of handling a wide range of diseases. Our location provides demographic diversity enabling access to a broad variety of patients with different medical conditions. Our track record includes a successful portfolio covering novel vaccine candidates, innovative therapeutics and advanced diagnostics for infectious diseases.
WE ARE CURRENTLY EXPANDING OUR EXPERTISE to include respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) demonstrating our commitment to addressing diverse medical challenges.
Collaborations
We have established partnerships with leading academic institutions, CROs and philanthropic organizations such as the NIH, WHO and the Bill & Melinda Gates Foundation, underscoring our global reputation for excellence. Through these collaborations, we have strengthened our capacity and diversified our abilities to an international level. Our networks built across the country and beyond, have been instrumental in our efforts to continually make an impact. Through these collaborations, our Principal Investigator, Prof. Jesse Gitaka, has been able to establish a state-of-the-art laboratory outfitted with the latest technology.
THIS ADVANCEMENT has significantly enhanced our capabilities and allowed us to build a strong portfolio in the scientific world.
Publications & Thought Leadership
Multiple peer-reviewed articles and conference presentations highlight CRTMCD’s scientific impact and operational proficiency.
OUR COMPETENT TEAM has leveraged these opportunities to network and build connections that extend far beyond.