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Background: There is a clear rationale for conducting clinical research in low- and middle-income countries (LMIC), given the majority of global burden of disease exists in these regions. The majority of clinical trial research, however, is still being conducted in high-income countries, as organizational and infrastructure challenges remain in LMICs. As an initial step to improve clinical trial research capacity in Rwanda, the Ministry of Health has recently ramped up to streamline regulatory frameworks and improve research conducive environment in terms of capabilities and infrastructure. We, therefore, reviewed clinical trial research readiness status in ten local hospitals. Methods: In 2015, a site visits to screen the clinical trials capabilities and readiness status among health facilities in Rwanda was conducted. We qualitatively assessed clinical trial readiness using a standardized clinical trials assessment checklist that is based on five major categories of “Laboratory infrastructure;” “Pharmacy infrastructure;” “Data documentation and storage procedures;” “Technology;” and “Trainings, experience & certification.” Results: In general, we found the most hospital sites, particularly those located in the capital city (Kigali), met adequate Clinical trials readiness requirements. However, few clinical trials projects have been implemented in the sites. Strengthen partnership with private sectors primarily pharma and biotech companies may increase number of clinical trials to be hosted in Rwandan sites. In all except for two sites already had electronic medical records in place, showing adequate documentation and recording standards. As expected, some deficiencies existed between different hospitals. Automatic data backup, sample storage capacity, teleconference and telemedicine technologies were also needed in some of the hospitals. Conclusion: A need to advance human research capabilities among health care providers is key to upgrade standards for clinical trials readiness in the local hospitals. Medical Research Center (MRC) at Rwanda Biomedical Center in collaboration with academic institutions has started the journey to address clinical research human resource capabilities and infrastructure deficiencies through CPD model and clinical research mentorship in local health facilities. Funding Statement: This study was funded by the Government of Rwanda. Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: This study was approved by the Rwanda National Ethics Committee and by the Rwanda Ministry of Health.

Background Harnessing research for enhancing capacity for evidence-informed policies is key for sustainability in countries that are still facing poverty-related diseases. During current customised medicine and drug-resistance era, priority has shifted to clinical research making clinical trials a powerful tool in availing tailored and affordable drugs and medical interventions. There is need to address disparities in clinical research capabilities worldwide, particularly sub-Saharan Africa, where disease burden is rampant. We share our achievements and lessons learnt so far from establishing three new clinical research sites among the eleven targeted for in Rwanda. Methods Referral, provincial and specialty hospitals have been selected by the Ministry of Health as potential clinical research sites. Based on the International Conference on Harmonization in Good Clinical Practice (ICH-GCP), a baseline assessment was conducted. Three best-scoring hospitals were developed to become clinical research sites by: alignment with the national priorities; acceleration of current laboratory accreditation processes, improvement of data management, clinical infrastructure, financial management systems; careful recruitment, continuous training and a retention plan of critical research staff; collaborations with private clinical research organisations; marketing of research sites to funders; strengthening institutional review boards; creation of local ownership; and diversification of the research portfolio. Results Clinical research sites established are Centre Hospitalier Universitaire de Kigali (CHUK) in Kigali city, Centre Hospitalier Universitaire de Butare (CHUB) in Southern province, and Butaro Hospital in Northern province with 26, 26 and 11 dedicated staff, respectively. Sites have minimally a clinical research laboratory under accreditation process, 5 private medical/examination room, a counselling rooms, a data management unit, a waiting area, a pharmacy with restriction-area, administrative area, tele-conference/training room. Conclusions Development of novel clinical research capacity in resource-limited settings is feasible, with considerable time and resources. Political initiative is a key element for sustainability. Staff retention is the main challenge. For minimising the risk, partnerships between experienced clinical organisations and sponsors are vital for financial stability and knowledge transfer.