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