Medical Device Clinical Trial Study Design and Protocol Development
The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study. Careful planning and consideration of device clinical trial study design is an important step in achieving the desired primary and secondary endpoints you desire in the most cost effective and timely manner possible.
Depending on your ultimate goal, our device clinical consulting team will work closely with you to ensure that the clinical investigation plan appropriately represents you to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and adheres to Good Clinical Practice (GCP) guidelines, as well as all federal and local regulations.
The Emergo consulting team will help develop a medical device clinical trial protocol which includes:
- Introduction which includes general information on the sponsor and investigational device, as well as background information about why the trial is being conducted, a description of the trial purpose and objectives including a statement of primary and secondary endpoints
- The Clinical Investigational Plan which includes the following information:
- Study design, subject selection, inclusion, exclusion and withdrawal criteria
- Efficacy and safety assessments and variables
- Overview of trial procedures and methods of assessment
- Treatment administration, packaging and labeling, storage, subject assignment, disposition and compliance requirements
- Adverse Event (AE) reporting including definitions of adverse events, serious adverse events, device-related events, pregnancy, events of interest and collection and reporting requirements
- Statistical methods to be used, sample size, analysis plan, termination criteria, randomization methods, etc.
- Ethical considerations including a description of the role of the Independent Ethics Committee (IEC) or Institutional Review Board (IRB), ethical conduct of the study, subject information and consent
- Data quality assurance, source documentation and case report form completion, monitoring expectations, data handling, record keeping investigator training, audit/inspection procedures and handling of Personal Health Information (PHI)
- Investigator selection criteria, study completion procedures and reference list
- If applicable, Healthcare Utilization Information (HUI) collection and analysis procedures, customized appendices such as the Investigator Agreement, List of Abbreviations and Definitions of Terms, Informed Consent Form (ICF) template, etc.
Depending on your budget and availability of in-house resources, Emergo can be involved in all or part of your clinical trial study design and protocol development.