Contract Research Organization (CRO) Services

• Single and Multi-Site Study Management
• Image Analysis
• Visual Assessment Training and Certification
  We have put together a certification program to train individuals on visual assessment. SGS uses this certification program to train their PhD, MD and clinicians and also offers this certification to individuals outside of SGS. The certification program is customized based on the needs of the client and can include a brief overview of the function of skin, background on grading scales being used, review of photo numeric scales, combination of grading of photographs and live subjects and an exam. The training is extremely useful to train individuals with no experience and to calibrate graders in multi-site trials.
• Protocol Development
  SGS offers protocol writing for clinical trials placed at or outside of SGS. We can prepare the protocol using one of our templates, which adheres to applicable ICH Guidelines, a protocol customized to the Sponsor’s preference or one provided by the Sponsor.
• Case Report Form and Study Document Development
  For data that cannot be collected through Electronic Data Capture (EDC), SGS has template study documents and logs which can be customized to the study design or a Sponsor’s preference or we can use documents provided by the Sponsor. We can prepare any study documents for clinical trials placed at or outside of SGS.
• Institutional Review Board (IRB) Management
  SGS will handle all your IRB management needs for clinical trials placed at or outside of SGS. We partner with IntegReview Ethical Review Board and Western Institution Review Board for studies conducted at SGS, but also have extensive experience in working with a variety of IRBs in the United States and Japan and can use one you prefer.
• Quality Assurance Monitoring
  SGS has its own Quality Assurance Unit that monitors your study to verify it is being followed according to the protocol and Standard Operating Procedures (SOPs), complying with regulatory and Good Clinical Practice (GCP) standards and ensure the accurate reporting of data. The Quality Assurance Unit monitors and audits each step of the study including, protocol development, compliance with all study procedures, collection of the data, case report form and source document review, statistical analysis, and clinical study report writing.
• Data Analysis
  SGS experienced statistics department will work with you to develop statistical analysis plans (SAP) and customized data presentations for clinical trials conducted at and outside of SGS.
• Clinical Study Report Writing
  SGS provides clinical study report writing for clinical trials conducted at and outside of SGS following ICH or ISO guidelines. We can prepare the clinical study reports using one SGS’s templates, incorporating any sponsor preferences, or a template provided by the Sponsor.
• Use of Electronic Data Capture (EDC) System (21 CFR Part 11 Compliant)
  SGS has developed its own EDC system for data collection of clinical assessments during your trial to provide more efficient, quicker and timelier data analysis and topline reporting than paper case report forms. SGS EDC has been validated as being 21 CFR Part 11 Compliant. We can also use another EDC system provided by a Sponsor.
• Photography Assessments by Expert Graders
  Our expert clinical graders can visually assess photographs from any clinical trial for various skin attributes. Examples include hyperpigmentation, fine lines and wrinkles, sagging, shine, redness, etc.