Study Design & Protocol

Protocol deviation, amendments and incorrect data gathering will jeopardize the success of an early phase clinical trial. Mitigating this risk requires careful planning, adept study design and scientifically correct and feasible protocols.

We provide a comprehensive range of study and protocol design solutions to help you anticipate problems before they happen. Our multidisciplinary consultants support you in creating flexible, accurate and trusted study designs for early phase and FIH clinical trials, helping you to achieve high-quality, safe and compliant data in all aspects of your study.

We Facilitate Defining:

• Objectives and endpoints
• Population and sample size
• Starting dose/dose escalation
• Stopping and progression rules
• Assessment schedules
• Biomarkers and innovative tools
• Statistical and other biometric methodologies

Our clinical research experts and experienced medical writers support you throughout the process – from study design and synopsis writing to protocol development.

SGS is recognized as the benchmark for quality and integrity in clinical research design writing and protocol development. We are a leading early phase contract research organization (CRO) and operate one of Europe’s most advanced phase I units, specializing in complex adaptive FIH and other clinical pharmacology trials. Whatever your requirements, we have the capabilities in place to support your clinical trial objectives.