About Dr. Amos Ndhere MD, MS

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

Regulatory affairs

2024-01-25T11:41:02+00:00

NAVIGATE GLOBAL REGULATORY WITH CONFIDENCE Regulatory Approvals Annually Regulatory Inspection Outcomes Adverse Event Reporting Timeliness Navigating Clinical Trial Regulatory Is Overwhelming Clinical trial regulatory application is complex and constantly changing—compliance can be difficult and a costly affair, especially for international clinical trials. Challenging global compliance with diverse guidelines Time-consuming adaptation of documents (protocol, ICF, IB, CRF) to new submission rules Prompt reporting needed for Safety (AEs, SAEs, AESI) Risks include Warnings, Terminations, Fines, Convictions, Liabilities for non-compliance Delays affect trial timelines and budgets Added pressure from Regulatory Inspections and Audits SCHEDULE MEETING You Don't Need  To Figure It Out. Your clinical product is so valuable. Partner with an expert team committed to your regulatory success. [...]

Regulatory affairs2024-01-25T11:41:02+00:00

Project management

2024-01-25T11:49:54+00:00

EXPERT CLINICAL TRIAL PROJECT MANAGEMENT Maximize Efficiency and Minimize Risk of your Clinical Trial with our Proven Project Management Methodology based on PMI Methodology Our clinical trial project management service is designed to help you navigate the complex and ever-changing landscape of Phase I-IV vaccine and treatment clinical research in Africa. At ACE Research, we pride ourselves on providing exceptional value to our clients through our collaborative approach to project management. Our Project Managers work closely with you from the beginning to the end of each project, ensuring that every aspect is carefully planned and executed. We use a proven PMI methodology, including standardized processes and metrics, to monitor progress, identify and mitigate risks, and ensure timely project completion - all while maintaining our reputation for delivering high-quality results within budget. [...]

Project management2024-01-25T11:49:54+00:00

Clinical Monitoring in Africa

2024-01-25T11:36:33+00:00

OPTIMIZING CLINICAL MONITORING IN AFRICA Clinical monitoring for research in Africa can be challenging. Clinical monitoring in Africa can be difficult because of varying clinical site practices (SOPs),  ICH-GCP experience, and regulatory guidelines. While global CROs provide a sense of familiarity, they lack agility and adaptability unique to clinical research in Africa. Their cumbersome data collection and oversight approach don’t just strain budgets—they stretch timelines and overwhelm sites, leading to diminished enthusiasm. Risk-Based Monitoring CONTACT US TAILOR YOUR CLINICAL MONITORING FOR SUCCESS Adapting a global gold standard monitoring to suit the unique conditions in Africa is essential to the success of your clinical monitoring in Africa. SCHEDULE MEETING ACHIEVE CLINICAL RESEARCH SUCCESS [...]

Clinical Monitoring in Africa2024-01-25T11:36:33+00:00

Rescue studies

2023-03-19T17:35:05+00:00

POST-MARKETING COMMITMENTS: ENSURING SAFETY AND EFFICACY THROUGH OUTCOME DECISIONS AND RISK MANAGEMENT We offer late-phase clinical study services with an aim to further evaluate the safety, effectiveness, and long-term risks and benefits of a product in a larger and more diverse patient population. Our services help our clients play a crucial role in ensuring the safety and effectiveness of drugs and medical devices after they are approved for use and help them to provide valuable information to physicians, patients, and regulatory authorities. Extending our integrated model and expert teams into late phase, ACE Research can conduct both interventional and non-interventional type studies including: Phase lllb and IV randomized clinical trials Observational epidemiologic studies Expanded access programs Post-authorization safety studies Health Economics and Outcomes Research Competitive marketing claims studies Pharmacovigilance Registries

Rescue studies2023-03-19T17:35:05+00:00

Drug Safety and Pharmacovigilance

2023-01-25T23:27:21+00:00

PHARMACOVIGILANCE At ACE Research, we understand the challenges that safety teams face in managing increasing caseloads, new data sources, and changing regulations, all while facing budget constraints. With our expertise, experience, and innovative approach to safety management services, we can help you alleviate this pressure and improve your overall efficiency and compliance. Our compliant multivigilance services cover the entire lifecycle of your product, from clinical trials to post-marketing surveillance, allowing you to manage adverse event cases and signals more quickly, accurately, and efficiently. Partner with us to strengthen your safety program and meet your growing needs compliance requirements with confidence. Pharmacovigilance Operational Services Ipsum dolor sit amet consect adpisic elit eiusmod tempor incididunt labore am tum dolore magna. Ipsum dolor sit amet consect adpisic elit eiusmod tempor incididunt labore am tum dolore magna. Ipsum [...]

Drug Safety and Pharmacovigilance2023-01-25T23:27:21+00:00

Services

2021-04-29T21:20:45+00:00

ASSAY METHODS SEARCH Put our Africa Experience to Work for You To Safely Deliver Clinical Trials. CONTACT US ALorem ipsum dolor sit amet, consectetur adipiscing elit. In et scelerisque sem. Nunc molestie neque augue, at gravida mi blandit eget. Aenean eu augue id lacus eleifend interdum. Cras sit amet metus sit amet velit lacinia ullamcorper. Nam facilisis a orci quis tempus. Vivamus id odio justo. Curabitur ut euismod metus. Donec nec neque non ligula vestibulum blandit id sed eros. Vestibulum cursus in ligula lacinia lobortis. Morbi at velit at velit auctor efficitur ut ac justo. Phasellus porttitor, elit vitae scelerisque vestibulum, nunc libero bibendum massa, ut ultrices quam libero vel dolor. In sit amet ultricies dolor. Suspendisse maximus odio mollis massa tristique rhoncus. Keyword Research Duis vel tellus a ante convallis [...]

Services2021-04-29T21:20:45+00:00

Become an Investigator

2022-12-13T20:31:54+00:00

JOIN INVESTIGATOR NETWORK As a leading Africa CRO, ACE Research is looking to expand network of research sites and clinical investigator partners across Africa. If you're intrigued in participating in clinical research, we provide the chance to join an accomplished clinical research team. Benefits of Clinical Research Offer new and innovative and potentially lifesaving treatment options to patients locally Increase the service offerings and referrals to your medical practice, and thus increasing competitiveness Contribute to scientific breakthroughs of new therapies that can save or improve lives Create new revenue streams for medical practices and diagnostic service providers Achieve professional advancement and recognition BECOME AN INVESTIGATOR The majority of clinical trial investigators are physicians (MD, DO’s) in practice. You need to [...]

Become an Investigator2022-12-13T20:31:54+00:00
A leading CRO for vaccine, drug, and device clinical research

CONTACT US

  • KENYA OFFICE
    Tom Mboya Drive, Milimani
    P.O Box 3897-40100,
    Kisumu, Kenya

  • UNITED STATES
    838 State Road,
    Hinckley, OH 44233
    United States

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