A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Archive for August 2018

InClin’s GCP and QA Team to Instruct Trial Master Files and Investigator Site Files Training Module

InClin is pleased to announce that Tony Cruz, InClin’s Vice President of Quality, and Scott McCulloch, InClin’s Director of Clinical Quality Assurance, will be participating as instructors in a training module hosted by The Academy of GCP entitled “Module 082018: Trial Master Files (TMF) and Investigator Site Files (ISF)” on Wednesday, August 15, 2018 at Stanford University. This module is designed to educate Clinical Research Professionals on how to design, implement, and manage the highest quality Trial Master Files (TMF) and Investigator Site Files (ISF). In addition, this module will provide hands-on coaching on how to successfully organize, prepare, process and maintain these essential documents to facilitate successful regulatory inspections.

“The ever-changing landscape of the drug development space, which include increasingly rigorous regulatory requirements, is driving pharmaceutical and biotech companies to take a hard a look at their procedures and processes,” said Dr. Cruz. “Companies are actively embedding Quality throughout their development process to ensure that they are inspection-ready at all times. This training module will help educate drug development professionals on how to design, implement, and manage the highest quality TMF and ISFs as well as provide hands-on coaching on how to successfully organize, prepare, process and maintain these essential documents to facilitate successful regulatory inspections.”

To register for this event, click here: Module 082018: Trial Master Files (TMF) and Investigator Site Files (ISF)

Event Details:

Date: Wednesday, August 15, 2018 (8:00 am – 5:00 pm Pacific)
Venue: Stanford University, Faculty Club

Instructors:


Tony Cruz, Vice President of Quality


Scott McCulloch, Director of Clinical QA

About InClin
InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. We are a single source provider of an integrated full suite of clinical development services from Phase 1 through Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, as well as strategic consulting services. For more information feel free visit our website or contact us at our email address below.

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