Essential Documents in Clinical Trials
Dr. Amos Ndhere MD, MS2025-06-13T17:35:00+00:00Clinical trials rely on a wide range of documentation to ensure ethical conduct, regulatory compliance, and scientific validity. Under the International Council for Harmonisation (ICH) GCP guidelines, essential documents must be maintained to demonstrate that a clinical trial was conducted according to protocol and applicable regulatory requirements. These documents are foundational, ensuring clinical trials are compliant and inspection-ready Trial Master File (TMF), which is essential for ensuring the integrity and success of clinical research. This guide will explore best practices for improving document processing, helping you maintain a TMF that stands up to scrutiny and supports the advancement of medical research. Understanding Essential Documents in Clinical Trials ICH GCP E6(R2) defines essential documents as those that "individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced." These documents help [...]
3 Mistakes in Choosing EDC Systems
Dr. Amos Ndhere MD, MS2025-06-13T16:07:53+00:00Choosing the right electronic data capture (EDC) system is critical for the success of clinical trials in Sub-Saharan Africa. An ideal Electronic Data Capture (EDC) system for clinical trials must be secure, user-friendly, and compliant with global regulatory standards such as FDA 21 CFR Part 11, ICH GCP, and GDPR. It should support real-time data entry and validation, audit trails, role-based access control, and integration with other eClinical systems like ePRO, CTMS, and lab data. The system must ensure data integrity through automated edit checks, version control, and secure backup. Additionally, adherence to CDISC standards (e.g., SDTM, ODM) is essential to facilitate data interoperability and regulatory submission readiness. Sponsors of international clinical trials make common mistakes while choosing an EDC for their research. Here are three common mistakes. Mistake #1: Overcomplicating the Selection Process Many sponsors [...]
Site Management Organization
Dr. Amos Ndhere MD, MS2023-11-17T12:31:49+00:00SITE 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 [...]
Job Application Forms
Dr. Amos Ndhere MD, MS2025-09-18T19:27:01+00:00JOIN OUR TEAM Join our talent network that inspires hope in millions of patients while elevating your career to new heights. Apply Now Apply now and be part of our transformative journey.
COVID-19 Resources
Dr. Amos Ndhere MD, MS2025-06-13T15:52:02+00:00Utilizing Ebola virus, COVID-19, and Marburg virus preparedness playbook to accelerate novel vaccine and therapeutic clinical trials
COVID-19 Site Feasibility Assessment
Dr. Amos Ndhere MD, MS2025-06-13T15:49:59+00:00Since 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 fight against Ebola
Dr. Amos Ndhere MD, MS2025-06-13T16:36:24+00:00The 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
Dr. Amos Ndhere MD, MS2025-06-13T16:38:07+00:00Why 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 Burden Clinical research in Africa can lead to [...]
Leveraging Ebola Preparedness for COVID-19 Trials
Dr. Amos Ndhere MD, MS2025-06-13T16:38:42+00:00The 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 [...]