Clinical Trials Monitoring and Site Management

Clinical Trial Monitoring

ClinWin retains a team of experienced Clinical Research Associates (CRA’s) to monitor and manage clinical trials. Our team is involved in Investigator and Site Selection, Site Identification, Pre-Site Initiation, Budgets/Contracts negotiation, Site Initiation, Interim Monitoring and Close Out Visit.

We have experience in monitoring wide range of clinical trials, including bioequivalence studies, Phase I-IV clinical trials.

We provide in house Entry and Advanced level Clinical Trials Monitoring training, including registering Our staff are 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 have developed cordial relationships with site staff. We assign lead and a back-up CRA for all our assigned projects.

Medical Monitoring

We provide medical monitoring services through partnership with highly experienced local and international Physicians, who are experts in wide range of medical specializations. These include: infectious diseases, Pediatrics, Internal Medicine, Oncology, Gastroenterology, Reproductive health among others.

Site Operations & Management

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:

Ethical Review and 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 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 and Retention Servies

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.We deploy innovative approaches to patients’ recruitment, including: the online platforms, phone calls, contact tracing, peer networks among others.
Our participatory approach to patient recruitment and retention model has proofed to be efficient and sustainable in short and long run.
We have experience in patient 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.

Clinical Project Management Services

We are committed to deliver clients projects efficiently on time, quality and cost. Our projects management team oversees all our internal and external outsourced projects.
The team manages the development process, setting specific targets and utilizing various metrics to ensure that a project moves forward in the right trajectory, resources are used optimally and client satisfaction is met.
This team oversee the implementation of a work breakdown structure, communication plan, and a risk and contingency program for each study.
We assign dedicated and experienced Project Manager who is the main contact and responsible for coordinating the team of highly experienced and qualified professionals assgned to each project.

Project Finance Management

We offer projects financial management services, including budgets development services for Investigator sites, Physician practice and clinics and Sponsors. We support our clients as per need basis on:

  1. – Budget proposal development
  2. – Contracts negotiation
  3. – Clinical Trials Agreements
  4. – Grant management
  5. – Donor financial reporting
  6. – Training on grant management, bookkeeping and reporting
  7. – Simple book keeping and financial reporting tools

Health Systems and Outcomes Research

We bring together broad and multidisciplinary Consulting team in real world study design and implementation, health systems research and commercialization.

Our researchers have gained wealth of experience in public health and health care Systems and Policy Research at regional and international level; including resource limited settings in developing world. We offer optimal solutions 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

We offer our clients in house and external data operations and delivery capabilities. Our team comprised of experienced Data Managers, Biostatisticians, SAS Programmers, medical writers and Information Managements specialists offer innovative solutions to our clients’ projects. We partner with our clients to offer advisory and support in:

  1. – Design of the study, case report forms (CRFs)
  2. – Electronic Data Capture training and deployment
  3. – Data entry and verification
  4. – Data consistency and completeness check
  5. – Data Management Systems audit trails
  6. – Operational and regulatory reporting
  7. – Data Management Plan development
  8. – Statistical analysis and scientific reporting
  9. – SQL system set up and training
  10. – Database development
  11. – Training of data management staff on ICH GCP, good documentation practices, document
  12. – Developing a data management plan, SOPs related to data management and ICH GCP
  13. – 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 the clinical research professionals and others interested in career change or growth. The courses are delivered in collaboration with KAVI Institute of Clinical Research, University of Nairobi. 
We employ participatory approach in our courses design and delivery. Face to face class room based and online courses are offered. 

Our faculty is comprised of pharmaceutical industry experts, product development partnerships, academia and trial sites 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. – Infectious Diseases
  8. – Data Management
  9. – Clinical Research
  10. – Methodology 
  11. – Projects Finance Management
  12. – Social science research methods

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