Our consultants are experts in GCP compliance. We work with organization to implement a quality management system that ensures a quality clinical trial. The Trial Master File (TMF) is a collection of documentation that demonstrates the trial was conducted to the study plan and in compliance with GCP. A poorly managed TMF puts an organization at risk during a regulatory inspection. Just in Time GCP works with your team to ensure inspection readiness.
Our staff of professionals includes industry experts with many years of experience in both site and sponsor organization, as well as ex-FDA inspectors. We are available to help you with simple questions or complex problems such as responding to FDA Form 483 and Warning Letters. We provide timely advice and answers to your questions. In addition our staff is available for compliance audits or inspection readiness assessments.
Compliance with Standards of GCP
Obtaining Informed Consent
Management of Adverse Events
Managing Source Documents
Obtaining Past Medical History
Managing Data Discrepancies
Measuring Vital Signs
Overview of Good Clinical Practice
Role of the Investigator
Human Subject Protection
Documentation of Adverse Events
Electronic Data Collection and Validation
Study Coordinator Orientation Programs
eTMF Systems Implementation
Whether you are a sponsor or a site, this newly issued draft guidance applies to you. This newly released guidance permits the direct documentation of data into the eCRF. Do you have the processes in place to support these requirements?
What is the difference between a protocol deviation and a protocol violation? In the December 2008 Compliance Program Guidance Manual or Clinical Investigator Inspections, the agency does not differentiate between a protocol deviation and violation. “A protocol deviation/violation is generally an unplanned excursion from the protocol that is not implemented.
Let us help you get back on track.