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

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

Feasibility assessment

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

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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

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
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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