Clinical Trials Monitoring and Site Management

Clinical Trial Monitoring

ClinWin retains a team of experienced Clinical Research Associates, involved in Investigator and Site Selection, Site Identification, Pre-Site Initiation, Budgets/Contracts negotiation, Site Initiation, Interim Monitoring and Close Out Visit.

The team has experience in monitoring wide range of clinical trials, including bioequivalence studies, Phase I-IV clinical trials.

In partnership with KAVI Institute of Clinical Research, University of Nairobi, ClinWin conducts biannual Entry and Advanced level Clinical Trials Monitoring training, including Good Clinical Practice (ICH-GCP).

Our CRA’s work closely with the sites and have developed cordial relationships with site staff. We assign lead and a back-up CRA for all our assigned projects.

Medical Monitoring

This provided in partnership with highly experienced local and international Physicians, who are experts in wide range of medical specializations, including: infectious diseases, Paediatrics, Internal Medicine, Oncology, Gastroenterology, Reproductive health among other therapeutic areas.

Site Operations & Management

ClinWin team conducts clinical trials coordination on behalf of the Physicians practices. Depending on the individual Physician 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.

Patient Recruitment and Retention Servies

ClinWin has adopted modern participatory model approaches to patient recruitment and retention. We have experience in patients recruitment for trials conducted in emergency settings, and HIV high-risk populations (commercial sex workers, IDUs, 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. We incorporate innovative approaches to patients’ recruitment, including online platforms, phone calls, contact tracing, peer networks, etc.

Ethical Review and Regulatory Affairs

Navigating the ethical and regulatory landscape in resource limited settings can be a challenge to clinical researchers. We provide ethical and regulatory support services to investigators and Sponsors.

Clinical Project Management Services

We are committed to delivering to clients’ projects on time, quality and cost. Our project management team oversees the clinical development process, setting specific targets and utilising various metrics to ensure satisfactory project delivery. We assign a dedicated and experienced Project Manager who is the main contact and responsible for coordinating the team of highly experienced and qualified professionals assigned to each project.

Project Finance Management

We support our clients as per need basis on:

  1. – Budget proposal development
  2. – Contracts negotiation
  3. – Clinical Trials Agreements
  4. – Grant management
  5. – Training on grant management, bookkeeping and reporting.

Health Systems and Outcomes Research

We bring together a broad and multidisciplinary Consulting team in Real World Evidence studies. Our researchers have gained a wealth of experience in Public Health, Health Systems and Policy Research in:

  1. – Health services research design and implementation
  2. – Operational research
  3. – Social science (qualitative and quantitative data collection and analysis)
  4. – Data collection tools developing and pre- testing Projects end term evaluation
  5. – Health economics surveys
  6. – Epidemiological studies
  7. – Ethical issues in research
  8. – Health care strategy, operations and governance advisory 

Data Management and Biostatistics

Our team comprises experienced Data Managers, Biostatisticians, SAS Programmers, Medical Writers, and Information Managements specialists. The services offered include:

  1. – Design of the study, case report forms (CRFs).
  2. – SAS programming. 
  3. – User support.
  4. – Electronic Data Capture training and deployment.
  5. – Remote monitoring. 
  6. – Operational and regulatory reporting. 
  7. – Data Management and plan development. 
  8. – Statistical analysis and scientific reporting.
  9. – SQL system set up and training.
  10. – Database development.
  11. – Developing a data management plan, SOPs related to data management and ICH GCP.
  12. – The creation of a data entry manual and training of data entry clerks on its use.

Training & Capacity Development

ClinWin staff providing training Site Initiation.

We offer general and tailor-made professional courses to meet the needs of clinical research professionals and others interested in career change or growth. The courses are delivered in collaboration with the KAVI Institute of Clinical Research, University of Nairobi. 
We employ a participatory approach in the design and delivery of our courses. Face to face classroom-based and online courses are offered. 

Our faculty is comprised of pharmaceutical industry experts, product development partnerships, academia, and trial site leadership.

We offer the following courses.

  1. – Clinical Research Associates (Monitors).
  2. – Training.
  3. – Project planning and Management.
  4. – Good Clinical Practice (ICH-GCP) for beginners and refresher courses.
  5. – Quality assurance.
  6. – Internal Monitors training.
  7. – Data Management.
  8. – Clinical Research.
  9. – Methodology.

Strategic Consulting Services

We provide clients with one stop strategic advisory and data driven decision analysis in support of their clinical development programs.
We partner with individuals, healthcare institutions, payers and biopharmaceutical companies to offer research and life cycle drug development advisory services. 
We leverage our expertise and experience to advise our customers on their business development programs and planned projects.
We offer our clients innovative and cost efficient solutions to make informed business decisions, notably in areas of:

  1. – Business processes engineering
  2. – Healthcare Business Strategy 
  3. – Regional Regulatory
  4. – Risk  and Compliance Operations 
  5. – Productivity and Performance evaluations
  6. – Contracts Negotiation and Legal Affairs
  7. – Clinical Resourcing and On Boarding Services 
  8. – Healthcare technologies access and commercialization 
  9. – Documents Translation services
  10. – Physician clinical trials marketing services

Project Finance Management

We offer our clients internal projects resourcing solutions by our functional outsourcing services.
The ClinWin teams are fully integrated within the client’s internal clinical development operations and are responsible for managing functions across the entire breadth of the client’s drug development pipeline.
This is an innovative alternative to the traditional, project-based approach and allow our clients to maintain greater control over their clinical development processes.
Our main resources, include Clinical Research Associates, Clinical Trial managers, Trial Assistants

Clinical Trials in Veterinary Medicine

We subscribe to One Health approach in our services offerings. We provide clinical trials management and support services in Veterinary Medicine. We ensure the studies are conducted in compliance with the VICH Good Clinical Practice.

Our Services:

  1. – Clinical trial monitoring
  2. – Quality Assurance
  3. – Trial sites identification
  4. – Field Coordination and data collection
  5. – Clinical Study Report writing and review
  6. – Project Management
  7. – Case Report Forms design
  8. – Master File set up and maintenance

Our Provisions

We provide wide range of capabilities in clinical drug development services including:

  • Protocol feasibility and site identification.
  • Study and site management
  • Clinical trials monitoring.
  • Regulatory and ethical submission.
  • Data management and Biostatistics.
  • Centralized and Risk Based Monitoring
  • Project management
  • Quality assurance audits
  • Supply Chain and Logistics
  • Patient recruitment strategies
  • Site assessment
  • Site contracting
  • Site capacity development
  • Training
  • Pharmacovigilance