Clinical Trial Site Management

2024-01-25T11:53:26+00:00

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 [...]

Clinical Trial Site Management2024-01-25T11:53:26+00:00

Biostatistics

2023-03-19T16:59:06+00:00

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.

Biostatistics2023-03-19T16:59:06+00:00

Safety Management

2024-01-25T12:01:10+00:00

SAFETY MANAGEMENT  Excellence in Trial Safety Management  Our top priority is to guarantee the safety and regulatory compliance of your trial participants. CONTACT US PRIORITIZING PATIENT SAFETY WITH ACE RESEARCH SERVICES Our experienced safety experts ensures: Your clinical trial meets the local, national, and global regulatory safety standards. The team at the site has been trained on safety protocols and compliance requirements. Accurate and timely AE/SAE/AESI Reporting 24/7 emergency readiness that ensures patient safety and upholds research integrity at all times. Ensuring strong data security measures to safeguard the confidentiality of patients' data.

Safety Management2024-01-25T12:01:10+00:00

Central laboratory services

2022-12-21T20:22:49+00:00

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Central laboratory services2022-12-21T20:22:49+00:00

Investigational Product Management

2024-01-23T20:23:12+00:00

INVESTIGATIONAL PRODUCT LOGISTICS  & INTEGRITY ACE Research has experienced experts for managing your Investigational Medicinal Products (IMP) throughout the life cycle of your clinical trial. We alleviate the hurdles of IMP importation, cold-chain storage, and dispensing at the site according to the protocol and regulatory requirements. Regulatory Approvals & Import Permits: ACE ensures all approvals are in place before IMP release request Storage, Dispensation, and Accountability ensuring precise IMP distribution and drug accountability. Importer of Record (IOR): we are IOR in 40+ countries. Post-Study Procedures: ACE oversees reconciliation and return or destruction of remaining study drugs in compliance with regulatory guidelines. ACE Research ensure the import, packaging, and release of IMP and comparator products utilizing US FDA and local country guidelines. IMP MANAGEMENT Excellence in IMP Handling and Storage We guarantee [...]

Investigational Product Management2024-01-23T20:23:12+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
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
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    Hinckley, OH 44233
    United States

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