Study Design
Global IQ’s team understands the sponsor’s need to expedite a product to market while maintaining data integrity and high clinical standards. Global IQ can assist in providing a well-designed plan which can achieve timely, successful, and ultimately, cost-saving results.
Global IQ’s experts can help you by:
- Defining the study hypothesis
- Developing the most suitable experimental design
- Reducing the placebo effect through competent study design and training
- Optimizing sample size
- Developing a statistical analysis plan
- Identifying a strategic population
- Advising on protocol development
- Writing the protocol
- Meeting with regulatory authorities during protocol development
- Proposing a development strategy that aids with suitable dose selection and proof-of-efficacy.
Our team is experienced with a number of international regulatory agencies, and all protocols and experimental designs are written in accordance with ICH-GCP guidelines and in adherence to regulations dictated by the following agencies:
- U.S.A. - Food & Drug Administration (FDA)
- Canada - Therapeutics Products Directorate (TPD)
- Mexico - Ministry of Health (SS)
- Australia – Therapeutic Goods Administration (TGA)
- European Union - European Agency for the Evaluation of Medicinal Products (EMEA)
- Argentina - ANMAT (Administration National Medications Alimentos and Technology) Administración Nacional de Medicamentos Alimentos y Tecnología Médica
- Mexico – SS (Secretaría de Salud)
- Brazil – ANVISA (Agência Nacional de Vigilância
Sanitária)