Additional Content
Ever since the Precision Medicine Initiative was announced in 2015, personalized medicine has taken off. Mapping the human genome, 3D printing, artificial intelligence and advanced scanning technology
FDA Fronts Pivotal Life Sciences Trend in 2020
This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.
4:06Fagron Uses MasterControl's Cloud Quality Management for their Personalized Medicine
Fagron is an international personalized medicine pharmaceutical company that recently started using MasterControl to improve its quality and manufacturing processes.
3:10Demo Introduction: MasterControl eTMF Software Systems
MasterControl’s clinical management system allows management at every phase of a clinical trial from a single platform.
1:26Demo Introduction: MasterControl eTMF Software Systems
Learn about MasterControl's eTMF product and how it can help your business. Learn more about eTMF Software Systems and more: https://www.mastercontrol.com/clinical/etmf-software-systems/
3:15MasterControl eTMF Manager
See how MasterControl’s eTMF Manager software solution enables real-time visibility into the status of all clinical study activities and trial master file artifacts.
1:20Demo Introduction: MasterControl Clinical Studies
Efficiently manage all clinical study information, including Trial Master Files (TMF) and data from participating study sites and clinical vendors supporting a study.
1:45Demo: MasterControl Clinical CAPA
MasterControl Clinical Excellence™ offers a comprehensive clinical quality management system (CQMS) that handles every component of clinical trials, including CAPA management.
1:08Demo: MasterControl Clinical Quality Management System
MasterControl Clinical Quality Management System (CQMS) provides you with the tools you need to manage quality and operations before, during and after your clinical trial.
1:36Demo: MasterControl eTMF Management System
Managing all the artifacts in a trial master file (TMF) can be a daunting task. Instead of relying on paper, use the MasterControl eTMF Management System to digitize the whole process.
1:33Demo: MasterControl Clinical Supplier Management Software
Managing vendors is difficult when vendor information is on different systems that don’t communicate with each other. MasterControl Clinical Supplier Management Software eliminates those problems.
1:09Demo: MasterControl Clinical Audit Management System
Using the MasterControl Clinical Audit Management System connects training, site, study and vendor management on the same platform.
1:07:09Transitioning from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR)
In this video, Linda Chatwin, Esq., RAC from UL explains how to prepare for the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).
1:20Completing an FDA Inspection With MasterControl
MasterControl customer Contract Pharmacal Corporation used to be a paper-based organization. They’ve greatly benefited from switching to MasterControl’s electronic quality management system (QMS).
FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments
This white paper examines the key points of the guidance and the thinking behind the FDA’s 2009 “Guidance for Clinical Investigators, Sponsors and IRBs”
The Top 5 Benefits of Electronic GLP Audit Management
This white paper discusses common audit-related challenges faced by non-clinical research laboratories that still use a paper-based quality system.
CAP Accreditation and Document Control
The College of American Pathologists (CAP) outlines the requirements and benefits of CAP accreditation for clinical laboratories.
How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance
Given the enormous cost, time, and effort involved in clinical research, sponsors and CROs need to mitigate risks and ensure compliance during development to be able to launch their products.