Clinical Trial/ Clinical Study

Clinical validation is one of the most important and critical aspects of demonstrating that the medical device or IVD works as intended. 

Xplore healthcare team offers following services in domain of Clinical Study

• Clinical protocol development, creating Clinical Evaluation Reports (CERs), and integrating clinical operations into the Quality Management Systems (QMS) of companies.
•  Formulation Development (QbD), Support for Clinical Trial, BE study and Toxicity Study and Technology and Site transfer etc. 
• Helping Hand to CRO’s 
• Support in Product Development and Technology Transfer, and support in BA/BE studies
  
• Pre-market and Post-market Clinical Requirements
• Post Market Clinical Follow up (PMCF) protocol
• Review of clinical data to evaluate appropriateness for approvals
• Clinical protocol and report as per ISO 14155 and Good Clinical Practice (GCP)
• Clinical operations procedures to set up in house clinical studies
• Creation of Scientific Publication Dashboard
• Post market surveillance strategy and execution,Complaint handling.