About Dr. Amos Ndhere MD, MS

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So far Dr. Amos Ndhere MD, MS has created 37 blog entries.

Patient Reported Outcome – Quality of Life Research

2022-12-21T20:37:52+00:00

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Patient Reported Outcome – Quality of Life Research2022-12-21T20:37:52+00:00

Translation

2024-01-25T12:41:22+00:00

BREAKING LANGUAGE BARRIERS Overcoming Language Barriers In Multilingual Clinical Trials Inaccurate translation of clinical trials can result in misunderstanding leading to incorrect dosing, protocol deviations, and compromised data integrity. It can also put you at legal and ethical risks leading to damaged reputation as a sponsor. ENSURING ACCURATE COMMUNICATION IN GLOBAL CLINICAL TRIALS Our translations ensure linguistic accuracy and cultural sensitivity for clear understanding across multiple languages. We use a clear and concise layout for informed consent documents to reduce the risk of misinterpretation and mistakes. Our research language uses simple terminology easily understood by participants, regardless of their educational background. Our translations have been evaluated for simplicity and comprehension by most Ethics Committees and have passed the test. We work with the local communities to ensure that the translations are culturally appropriate [...]

Translation2024-01-25T12:41:22+00:00

Quality management

2023-01-24T20:52:11+00:00

RISK-BASED QUALITY MANAGEMENT As the complexity of clinical trials increases, so do the risks of quality issues, resulting in longer resolution times and higher costs. These risks can significantly impact a study's operational success, making it more difficult to recruit patients and generate reliable results. Our Risk-Based Quality Management (RBQM) is built on a foundation of industry-leading expertise and a deep understanding of the latest ICH E6(R2) guidelines for Good Clinical Practice (GCP) guidelines and regulatory requirements throughout all elements of a study. Key Components of ACE Research RBQM Risk Evaluation, Risk Control, Risk Communication, Risk Review, Risk Reporting. US FDA Review Cycle Failure Between 2000 - 2012 were due to quality issues. Our team of experienced professionals provides a range of quality management services: Standard operating procedures (SOPs) [...]

Quality management2023-01-24T20:52:11+00:00

Data management

2024-01-25T12:08:18+00:00

QUALITY DATA FOR BETTER OUTCOMES Comprehensive CDM Compliance Meeting Regulatory and Industry Standards such as CDISC& CDASH, 21 CRF Part 11, ICH E2A, GDP, and HIPAA CONTACT US RIGHT DATA FOR EXPEDITED PRODUCT REGISTRATION Our CDM experts work closely with clinical trial teams to collect complete, accurate, and free from inconsistencies, which helps to boost confidence of stringent regulatory agencies and secure marketing authorization. eCRF design SAP Development Statistical Analysis TLFs ADaM / SDTM Standards Consulting Database development and testing Data entry and tracking Database closeout and archiving activities. Discrepancy management External data reconciliation Medical coding Lab safety data and Biomarker data management. With our CDM services, you can be assured of high-quality data to support regulatory submissions for marketing applications for your new [...]

Data management2024-01-25T12:08:18+00:00

Medical writing

2023-01-24T20:57:06+00:00

MEDICAL WRITING With our team of highly skilled and experienced medical writers, we offer unparalleled expertise in delivering scientifically valid and compelling content that effectively communicates your message. We have a keen understanding of the best methods to frame and communicate complex data, and we work closely with our clients to develop a structured format that meets their specific goals.Whether it's transforming raw data from complex trials into a compelling story that highlights patient impact or effectively communicating with regulatory agencies, our medical writers are here to guide you every step of the way, providing you with valuable support and delivering results that truly resonate with regulatory agencies.Our scientific-minded writing team has significant experience preparing clinical documents including Protocols, Informed Consent, Clinical Study Reports (CSRs), and Investigator’s Brochures. services & stats [...]

Medical writing2023-01-24T20:57:06+00:00

Medical monitoring

2022-12-21T20:23:24+00:00

Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci.Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci. Massa sed elementum tempus egestas sed sed. Diam vulputate ut pharetra sit amet aliquam id. Nam libero justo laoreet sit amet cursus sit. Eu augue ut lectus arcu bibendum at varius vel pharetra.  Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci. Massa sed elementum tempus egestas sed sed. Diam vulputate ut pharetra sit amet aliquam id. Nam libero justo laoreet sit amet cursus sit. Eu [...]

Medical monitoring2022-12-21T20:23:24+00:00

Feasibility assessment

2022-12-21T20:24:02+00:00

Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci.Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci. Massa sed elementum tempus egestas sed sed. Diam vulputate ut pharetra sit amet aliquam id. Nam libero justo laoreet sit amet cursus sit. Eu augue ut lectus arcu bibendum at varius vel pharetra.  Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci. Massa sed elementum tempus egestas sed sed. Diam vulputate ut pharetra sit amet aliquam id. Nam libero justo laoreet sit amet cursus sit. Eu [...]

Feasibility assessment2022-12-21T20:24:02+00:00

Patient Recruitment and Retention

2024-01-25T11:28:21+00:00

RECRUIT RIGHT PATIENTS, AT RIGHT TIME AT REASONABLE COST  Many recruitment strategies focus on ineffective vanity metrics, causing delays and financial strain. Traditional approaches don't align with the evolving clinical landscape. 50% of trials experience delays due to recruitment challenges 1 in 3 sites in North America don't recruit a single patient It costs an average of $6,533 to recruit one patient 30% of initially recruited patients drop out. It costs $19,533 to replace a patient who drops out Delays cost $600,000- $8 million a day for complex studies. BEGIN WITH CONFIDENCE Fast Recruitment of Known, Untapped Patients Breathtaking design for home living. We can help you achieve your recruitment goals and meet enrollment milestones while  reducing the time to recruit and [...]

Patient Recruitment and Retention2024-01-25T11:28:21+00:00

Site Training

2022-12-21T20:25:32+00:00

Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci.Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci. Massa sed elementum tempus egestas sed sed. Diam vulputate ut pharetra sit amet aliquam id. Nam libero justo laoreet sit amet cursus sit. Eu augue ut lectus arcu bibendum at varius vel pharetra.  Non tellus orci ac auctor augue mauris augue neque. Feugiat nibh sed pulvinar proin gravida hendrerit lectus. In nulla posuere sollicitudin aliquam ultrices sagittis orci. Massa sed elementum tempus egestas sed sed. Diam vulputate ut pharetra sit amet aliquam id. Nam libero justo laoreet sit amet cursus sit. Eu [...]

Site Training2022-12-21T20:25:32+00:00

Community engagement

2023-03-19T18:48:21+00:00

COMMUNITY ENGAGEMENT As the demand for new drugs continues to rise, bringing them to market has become more challenging and costly. With increased regulatory requirements for licensure and a wider range of patients to recruit, competition for patients is fiercer than ever. As a result, mounting pressure exists to reduce the time and cost required to bring new drugs to market. Our community engagement provides our clients with proven strategies to help achieve clinical study enrollment goals much faster. We help our clients to: Build trust and improves communication with MOH, community and stakeholders Ensure research questions and study procedures are culturally appropriate to enhance recruitment and retention. Communicate effectively and better decision-making for protocol compliance, fewer course corrections, and budget burns Improve the informed consent process and prevent early discontinuations Increase public awareness and reduce recruitment [...]

Community engagement2023-03-19T18:48:21+00:00
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