The dramatic increase in clinical trial activity around the world calls for ever-increasing emphasis on compliance with Good Clinical Practices (GCP) in order to safeguard the rights of human participants and to protect the integrity and validity of clinical data. Ask INNOPHARMA’s experienced Quality Assurance professionals to conduct in-depth audits of your systems, your investigator sites and your documents/reports to ensure that they are GCP-compliant. Discover how a modest investment in preparedness can yield significant savings in time and money.

Sample services:

  • GCP compliance audits
  • System validation audits
  • Complete range of clinical auditing capabilities

From individual site audits or system audits to multi-site, international quality assurance audit programs, INNOPHARMA Quality Assurance designs and delivers the QA services you need to meet increasingly stringent international requirements. We provide the systems approach required to ensure compliance with ICH/GCP consolidated guidelines. INNOPHARMA Quality Assurance can be included as a key component of an integrated clinical trial management program for pharmaceutical, biotech and medical device clients. Our audit experience includes a wide range of therapeutic areas and all development phases. We are equally adept at auditing clinical programs managed by INNOPHARMA, or stand-alone programs managed by our clients or other CROs. Below is a list of some of the audits we can perform. For each audit, we work with you to develop a client-specific audit plan to address in detail each task we will perform. At the conclusion of each audit, we prepare a written report, including detailed observations and a corrective action plan, if required.

Good Clinical Practice (GCP):

  • On-site Clinical Investigator Audits
  • Central File Audits
  • Database Audits
  • Clinical Study Report Audits
  • System Audits
  • Vendor Audits
  • Clinical Laboratory Audits
  • Phase I Facility Audits
  • CRO Audits

Good Laboratory Practice (GLP):

  • Non-Clinical Study Report Audits
  • Non-Clinical Laboratory Inspections

Standard Operating Procedures (SOP):

  • Designing a client-specific SOP framework
  • Writing, drafting, and reviewing SOPs