• Global Audits

GCP Compliance

GCP compliance can hinge on endpoint data submission. USDM has GCP compliancy expertise in analyzing clinical data entered remotely or paper summaries and comparing it to sponsor submitted data.

For example, the CRF template for a study must cover all components required by regulation and specifically 21 CFR Pt 50 for pharmaceuticals. Design assistance can help provide guidance in accurately presenting data.

Another example includes Physician Sample Primary/Secondary Packaging, Labeling, and Storage & Distribution. FDA investigates all components of a clinical study separately. A clinical investigator holds responsibilities for the study but the IRB oversees the activities for all studies in a setting, for example in a hospital. A sponsor compiles data whereas a CRO may just be a contractual leg of the study. Each one is investigated differently, but under the same regulations. Within the study setting, samples and the pharmacy program are inspected thoroughly. USDM provides services for all of these aspects.

Other examples include:

  • Data Management System Design
  • Data Integrity Verification
  • Clinical Investigator Data Validation Inspection Readiness
  • Sponsor Inspection readiness audit
  • IRB Inspection readiness auditContract Research Organizations (CROs) Inspection readiness audit
  • Sample Accountability & Fulfillment Programs

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials