Services

Full-service and Consulting expertise to meet your needs


 MonitorCRO's extensive regulatory knowledge, twenty years of field experience and input of quality management together with a dedicated team will help accelerate your success. We turn challenges into results with the following services: 


CONSULTING SERVICES

  • Clinical Trial Planning and Design
  • Recommendations for future studies/development projects
  • Regulatory strategy identification 
CLINICAL OPERATIONS
  • Feasibility studies for all indications
  • Study start-up including site identification, qualification, and selection
  • Development of study documents (i.e. Study protocol, Informed Consent Forms)
  • Essential document collection and maintenance
  • Trial Master File set-up and maintenance
  • Site management and monitoring
  • CRA management and quality control
  • Third-party vendor management
REGULATORY AUTHORITY APPLICATIONS AND APPROVALS
  • Initial Application, preparation for Ethics Committee and Ministry of Health
  • Initial application file preparation for Regulatory approval
  • Follow-up of applications
  • File preparation on regulatory and administrative changes during the study
  • Pharmacovigilance reporting to EC's and Regulatory Authority
  • Applications to RA for site coordinators
  • Institutional review board
  • Negotiating and concluding contracts with study sites
  • Submissions for public hospitals
  • Applications to the Ministry of Health on behalf of Phase I study sites  
  • IMP Importation Processes
SITE OPERATIONS
  • Site selection and feasibility assessment
  • Site contracts and agreements
  • Site monitoring
  • Site coordinator outsourcing
PROJECT MANAGEMENT
  • Non-interventional studies
    • If required pre-clinical study project management
  • Phase I, Phase II, Phase III and Phase IV studies
TRAINING
  • Basic medical training
  • Clinical trials training
  • Good Clinical Practice (GCP) training for study monitors, investigators, research staff and site coordinators
MEDICAL WRITING
  • Study Design and creation of initial Study Synopsis
  • Creating study Protocols
  • Drafting and finalising Informed Consent Forms
  • Informed consent form translation and adaptation from different languages
  • Creating Case Report Forms
  • Transforming CRF’s into eCRF’s
  • Study reporting in line with ICH-GCP requirements (E3)
  • Abstract and manuscript writing
DATABASE MANAGEMENT
  • In-house EDC Solutions and Electronic Data Handling
  • Database Design
    • Drafting and Finalization of Data Management Plans
  • Data Collection and Entry
  • Data Validation
  • Data cleaning and query handling
  • Medical Dictionary Management and Medical Coding
  • SAE Reconciliation
  • Quality Controls
BIOSTATISTICS
  • High-quality data analysis with in-house biostatisticians
  • Initiation of biostatistical work right from the start: statistical planning and sample size estimates
  • Full service clinical research Project biostatistics
  • Adaptive design strategies
PHARMACOVIGILANCE SERVICES
  • Serious Adverse Event Case Processing of Initial/ Follow-up reports
  • Case Narratives