Clinical Trials Monitoring and Site Management

ClinWin staff on site.

Clinical Trial Monitoring

monitoring as per the scope of our contracted work. We are involved in the all clinical research cycle from start up to close out visits as per sponsors' requirements.
Our experience ranges from Phase I-IV trials, across a range of organizations, geographical locations  and therapeutic areas.
Our monitoring team is trained on Good Clinical Practice (ICH-GCP), Good documentation Practices, Standard Operating Procedures (SOP's), Electronic Data Capture, Clinical Trials Management Systems (CTMS), scientific and medical topics, and updates on industry developments.
Our CRA's work closely with the sites, and we have developed cordial relationships with site staff. All studies have a lead and a back-up CRA.

Medical Monitoring
ClinWin provides medical monitoring services through partnership with highly experienced local and international Physicians, who are experts in wide range of medical specializations. These include Paediatrics, Internal Medicine, Oncology, Gastroenterology, Reproductive health among others.

Investigator Site Capacity Development
ClinWin approach to site development strategy is based on the intended clinical research study designs. We provide advisory and help site to complete all phases of a site development, including budgets negotiations, study start up, regulatory submissions and clinical trials agreements.

Site Operations
Clinwin team is experienced in clinical trials coordination on behalf of the Physicians practices. Depending on the individual Physicians practice needs, we provide contracted insourced services for Clinical Trials Coordination and management. We support Physician clinics sites in their day-to-day activities and administrative support, ensuring those activities are managed within ICH GCP and local regulatory requirements. We have dedicated team of consultants to advice on the following aspects of clinical research site operations:

    • Site assessment and qualification
    • Physical infrastructure planning and building
    • Study design and start –up
    • Staff training
    • Study implementation and management
    • Site maintenance
    • Routine site monitoring and Periodic auditing
    • Clinical research staff recruitment and retention
    • Clinical Trial Site Coordination

    Regulatory Affairs

    Navigating the ethical and regulatory landscape in resource limited setting in developing world can be a challenge to foreign and local investigators. ClinWin team has worked and understands the clinical research regulatory environment in Africa and Asia countries.
    We provide regulatory affairs and ethical review submission services to investigators and Sponsors.

    Patient Recruitment

    Inadequate patient numbers, unproven recruitment methods and patient retention is major cause of delays in delivering clinical trials projects on time, quality and budget. These can affect the desired study end points and safety.
    ClinWin participatory approach to patient recruitment and retention model has proofed to be efficient and sustainable in short and long run. We have experience in subjects recruitment for trials conducted in emergency settings, HIV high risk populations (male sex workers, drug abusers, and female sex workers), children and adolescents.
    We provide advisory support in recruitment strategies, recruitment materials development and pre-testing, community awareness, Community Health Workers and Liaison persons training and deployment.



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