TECHNICAL CENTER
The Technical Center is structured to serve as a base of expert consultants specialized in different medical and technical disciplines. The Institute has established an alliance with groups that will be complementary for specialized services. Thus, the organizational structure effectively accomplishes excellent client service with the flexibility to address a broad range of potential strategic solutions in medical specialties.
Our medical specialists provide expertise in clinical research protocols, including design, research, methodological details, statistical plans, and logistics advice. This knowledge base spans study management and evaluation, as well as report preparation in compliance with FDA and ICH guidelines. We can prepare your Investigator Brochures, adverse event reports, regulatory agency responses, and standard operating procedures.
The Institute's staff has many years of experience supporting and assisting clinicians, both in conventional laboratory testing and genotyping. The Center can assist in clinical trials, IRB interactions, nuances of informed consent, and possible impacts on recruiting time lines.
Pre-clinical expertise is available to design, implement or support safety programs and expert assessments, including development and validation of biomarkers. We offer scientific management and project support for all stages of pre-clinical development, pharmacokinetics and toxicokinetics, and regulatory filings covering compliance with GCP and GLP regulations.