Clinical Research   

Clinical Research on Pharmaceuticals and Natural Health Products
How can GLOBALTOX be of assistance?

GLOBALTOX Clinical Research services include:

• Effective needs assessments in co-ordination with clients’ goals;
• General consulting with clients;
• Determination of an efficient and cost-effective product research and development plan;
• Professional design, management and co-ordination of Phase I-IV clinical studies;
• Development of study protocols, case report forms, consent forms, drug accountability records, submission to Research Ethics Board, preparation of summary documents, and reports;
• Recruitment of qualified clinical investigators;
• Packaging and labeling of study drugs;
• On-site monitoring of clinical trials and site management;
• Adverse events reporting;
• Adherence to Good Clinical Practices guidelines.

Our services continue well beyond the management of the trial as well:

• Assistance with statistical analysis of study data;
• Production of concise, final reports which can be used directly for submission to the regulator;
• Provision of Expert Review and interpretation of other evidence and scientific literature;
• Interpretation and presentation of scientific issues to regulatory officials on behalf of our clients;
• Provision of scientifically defensible and effectively communicated results.
• Our primary concern is representation of our clients’ best interests in an objective and ethical manner