SITE MANAGEMENT ORGANIZATION (SMO) ACE Research SMO: Excellence in Site Management for African Clinical Trials The ACE Research Site Management Organization program provides access to over 400 community-based public, private, and non-profit hospitals in Africa with modern facilities, expediting your clinical research program. Access multiple sites through one central SMO. Simply multisite communication through a single contact. Streamline administrative and operational workflow. Standardize quality oversight, Safety, and SOPs Rapid multiple clinical sites start-up and activation TACKLING INEFFICIENCIES IN SITE MANAGEMENT The Conventional Approach to Site Management is fragmented This leads to increased sponsor oversight, prolonged timelines, increased costs, and potential risks to patient safety and data integrity. MAXIMIZING SITE MANAGEMENT EFFICIENCY AND COMPLIANCE We're setting new benchmarks [...]
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Since the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines were authorized for emergency use by the US FDA, millions of people in the United States have been vaccinated. However, finding reputable and high-quality sites for new Covid-19 vaccine and drug clinical trials can be a significant challenge. As the COVID-19 vaccine becomes more widely available in the West, new trials are facing challenges in meeting their enrolment targets. As a result, more clinical trials are being shifted to the global south, with sponsors determined to meet ambitious development timelines looking towards internal sites, including Africa. The traditional pre-COVID-19 approaches to clinical site assessment are not keeping up with the increase in Covid-19 trial complexities observed across the industry. Additionally, the COVID-19 pandemic has introduced unique challenges at clinical sites and highlighted new barriers to performance at previously high-performing international [...]
The Ebola Situation The Ebola virus crisis of 2019 stands as the most severe outbreak ever recorded in the Democratic Republic of Congo (DRC), and the second-largest outbreak of its kind in history. Containing the spread of the disease presents significant challenges, especially as the epidemic is raging in a conflict zone. The Ministry of Health in the DRC declared the latest outbreak of Ebola virus disease in North Kivu on August 1, 2018. This marks the tenth instance of a deadly virus outbreak in the country in the past 40 years. As of September 2, 2019, the Ministry of Health has reported a total of 3043 cases (2934 confirmed & 109 probable), comprising 2045 deaths, 911 survivors, and patients still undergoing treatment. The current Ebola outbreak in the DRC was declared a Public Health Emergency of [...]
Why conduct clinical research in Africa? Despite the region bearing a significantly higher disease burden, Africa has been marginalized from the mainstream scientific community. Africa presents a unique opportunity for groundbreaking advancements in scientific research, particularly in clinical research for new vaccines and treatments. McKinsey & Company estimates Africa's pharmaceutical market size will grow to $65 billion by 2020.Why Conduct Clinical Research in Africa?Clinical research is essential in developing new medicines and treatments, and their impact can be felt worldwide. However, there is a significant need for clinical trials to be conducted in regions with high disease burdens, such as Africa. The advantages of conducting clinical trials in Africa are vast and can have a far-reaching impact on healthcare provision and patient outcomes in the continent.1. High Disease BurdenClinical research in Africa can lead to progress in developing new medicines. [...]
The COVID-19 pandemic has been a global challenge that has impacted almost every aspect of life. The pandemic has presented unique challenges in Africa, including limited resources and infrastructure. However, Africa has faced similar challenges in the past with the Ebola outbreak, which has prepared the continent to respond to pandemics effectively. Leveraging Ebola preparedness for COVID-19 trials can enable pharmaceutical industry sponsors and researchers to complete time-sensitive COVID-19 clinical trials. Importance of Leveraging Ebola Preparedness for COVID-19 trials. The Ebola outbreak in West Africa in 2014-2016 presented a significant challenge, but it also served as a turning point in the continent's preparedness for pandemics. The outbreak highlighted the need for the continent to build robust health systems and improve emergency preparedness and public health response. The lessons learned from the Ebola outbreak have become invaluable in Africa's [...]
CLINICAL TRIAL SITE MANAGEMENT A competent site manager is essential for the success of your clinical research in Africa. Clinical trial site management can be a complex and challenging task. Every site possesses its own set of SOPs and distinct levels of expertise and experience. Infrastructure capabilities can vary significantly. It's possible that people may have different communication styles. This can lead to unclear communication and responsibilities, protocol procedures being misunderstood or implemented correctly, and communication delays. Access 100+ Sub-Saharan Africa Sites CONTACT US EXPERIENCED REGIONAL CLINICAL SITE MANAGERS Clinical Site Managers at ACE Research serve as single-point coordinators, building strong site relationships and ensuring your clinical research is safely, ethically and executed efficiently. Our site [...]
We offer a range of biostatistics services designed to support our clients' clinical research needs. Our experienced team of biostatisticians and programmers are experts in the latest statistical methodologies and technologies. We have extensive experience working with clinical trial data and can provide the following services to our clients: Statistical Analysis Plan Study Design & Randomization Programming of TLFs, ADaM Derived & SDTM datasets Generate Interim Analysis Reports & Final Statistical Report Data Transfers of Derived Datasets Develop/Review Clinical Study Report Our team of experts will work closely with you to ensure that your study is properly designed, analyzed, and reported. Contact us to learn more about how we can support your clinical research needs.