We provide a full range of services from project design to publication of results, including conducting phase I, II, III and IV studies for pharmaceutical companies, academic consortia, and investigator-initiated trials:
· Strategic advice for the development of the clinical research and monitoring plan.
· Development of clinical trial documents, case report forms, and data collection tools.
· Development of statistical plans, guidance on databases and results.
· Clinical trial budgets, scheduling and negotiations.
· Identification, assessment and administration of the site.
· Planning and execution of researcher meetings and liaison with regulatory bodies.
· Research agreements and preparation of legal documents.
· Compilation and management of test master files (paper and electronic).
· Preparation of the presentations and amendments of the Ethics Committee.
· Patient recruitment strategy and support.
· Monitoring and medical supervision (safety reports and regulatory compliance).
· Report writing.
· Closure and archiving of the study.