Clinical Trials Support provides comprehensive clinical

trial services (phases I-IV).

 

These may include, but are not limited to: feasibility assessment; protocol, Informed consent form (ICF), Case Report Form (CRF) preparation; regulatory issues; translation of study-related documents from English into Spanish and vice versa; study centers selection (suggesting potential study centers, pre-study site assessment); study materials management; start-up meeting organization; study initiation and close-out; monitoring and co-monitoring; SAE monitoring; project management; data management and statistics.

 

For every clinical trial our strategy is to assign a dedicated team for the duration of the project. This helps build the good working relationship which encourages success. To ensure that our clients receive the best possible service, our policy is to employ only highly qualified and experienced professionals

We prefer to assign clinical projects to a single dedicated clinical team, making your project their sole focus from start to finish.

 

We believe focusing our resources in this way fosters stronger teamwork, improves communication and helps us deliver timely, accurate data that gets your product on the market faster. We operate under current ICH and CFR 21 GCPs.

 


Quality Assurance.
Clinical Trials Support(CTS) considers quality assurance central to any study.


Our Services

 

  • • Feasibility and site selection
    • EC and CA regulatory submissions
    • Informed consent development
    • Study file set-up
    • Site contract and budget negotiations
    • Clinical monitoring and site management
    • Project management
    • Pharmacovigilence and safety surveillance
    • Clinical quality assurance audits
    • Translation and validation of study documents
    • Establishment of SOPs
    • Regulatory affairs and medical device consultancy
    • Medical writing and document development
    • Product labeling
    • Investigational supplies import, handling and dispatch
    • Data management and biostatistical analysis
    • Placement of co-source CRAs, CTAs and SSCs at
    client locations


Clinical Research About US

Clinical Trials Support provides on-site and on-line, customized About US designed to improve employee performance and overall regulatory compliance.