Quality Management Systems

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.

Clinical Industry Support

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.

Procedural Documentation

Compliance with Standards of GCP

Obtaining Informed Consent

Drug Accountability

Management of Adverse Events

Managing Source Documents

Obtaining Past Medical History

Physical Examination

Managing Data Discrepancies

Advertising

Investigator Responsibilities

Equipment Maintenance

IRB Communications

Measuring Biometrics

Measuring Vital Signs

Training

Overview of Good Clinical Practice

Role of the Investigator

Human Subject Protection

Documentation of Adverse Events

Source Documentation

Quality Management

Electronic Data Collection and Validation

Study Coordinator Orientation Programs

General Screening

Trial Master services

TMF Plan

TMF Audit

Vendor Selection

eTMF Systems Implementation

FDA HSP/BIMO Support

Whether you are a sponsor or a site, this newly issued draft guidance applies to you.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?

Protocol Deviation

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.