Services
We deliver a variety of high quality services. Those are Clinical study set-up, management, monitoring and co-monitoring but also Medical writing and editing. You get a personal, flexible and professional service from a field based clinical consultant with full office facilities. Hereunder an overview of our services :
Project Management
- Investigator Recruitment, Site Identification and Selection
- Investigator Contract Negotiation ( Hospital/PI/Other departments)
- Investigator Training
- Qualification visits, Pre-Study Site Visits, Site Training and Initiation Visits
- Study Monitoring, Progress tracking and Close out Visits
- Training and Mentoring of Monitors
- Drug accountability
- Source Data Verification (100% or sample monitoring) : paper and electronic CRF
- Monitoring reports in an acceptable format for the Client.
Monitoring Services
- Open communication with the client to understand the clients’ needs
- Coordination and planning of budgets inclusive the study-budgets
- Coordination of people and time management using our own network or client network
- Dedicated to improve results
- High quality delivery of work even under pressure due to timelines or other restrictions
- Selection of research locations worldwide
- Responsible for the set-up and maintenance of the administrative structure and the infrastructure of the project(s)
- Establish and guard study timelines and protocol specific Standard Operating Procedures.
Clinical Quality Assurance and Control
- Case Report From Review (paper and electronic / 100% or sample) and Data Retrieval
- Drug Accountability Reviews
- Monitoring and Follow-up of Adverse and Serious Adverse Events
- Data Privacy Protection Policy
- Open Communication with the client to questions and requests for information during any part of the study
Site Management
- Site File Updates
- Source Document Verification
- Screening Strategies
- Enrolment Tools
- Specific Investigator Assistance
- Safety Monitoring
Data Management
- Data Entry (paper and electronic)
- Data Review and Cleaning/Clarification
Regulatory Consulting
- Preparation and Submission of Regulatory documents
- Knowledge of local regulations
- Submission to Competent Authorities and/or Local/Lead Ethic Committees
- Design, Review and Translation of Clinical Trial Materials(Patient cards, Investigator Tool cards, Diaries,….etc)
- Objective Advice on advertising and promotional materials.
Miscellaneous
- Organizing Investigator meetings or scientific meetings
- Feasibility studies
- Training