Our services include:
Contract development, negotiation and execution
Regulatory set up (Submission for the Independent Ethics Committee (CA/CEC) and Regulatory approval)
Patient Recruitment assistance (development of recruitment tools)
Site initiation and trial close-out operations
Independent monitoring
Trial-related documents archival and maintenance
Medical Monitoring/ Safety Reporting (SAE) to the Sponsor or CRO and the CA/CEC and RA
Data Protection Counseling
Management of Protocol Violations (Advising & alerting investigators of potential protocol violations)
Management of ICH GCP violations (Advising & alerting investigators of potential ICH-GCP violations)
Development of Site SOP’s/Site Quality Assurance
Site training (ICH GCP, Regulatory, Ethics)
Data Management
Patent Protection Management
Feasibility Studies
Project Management
Medical writing/Protocol Development and CRF Design
We offer comprehensive support across all phases of clinical development
We have the experience in training staff for both Sponsors and Investigators
We provide a comprehensive and flexible solutions.
We have highly trained, qualified and experienced research nurses.
We offer this service to the Sponsors and Clinical Research Organizations (CROs).
We offer services that can reduce the registration process and obtaining a drug license for our clients.
We provide a clinical trial related services to our clients.
We are looking for freelancers