Logistics & Supply Chain Management
Research Library
|
|
BioClinica, Inc.
|
Global clinical trial solutions. Real-world results.
The Case for Functional Outsourcing of EDC
The Business Case for Functional Outsourcing of EDC
Summary: This white paper is intended for clinical operations managers who are either considering their electronic data capture (EDC) options for the first time or re-evaluating previous decisions. This paper looks at the primary approaches for ...
|
|
|
DEACOM
|
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
|
|
|
Lean & Mean Business Systems, Inc.
|
Medical Device Manufacturers have always focused on bringing innovative high quality products to market. Yet shifting financial, regulatory and globalization landscapes call for closed-loop product management strategies that can keep up with the increasing innovation tempo and complexity of medical devices while at the same time, lower cost, increase quality, and facilitate compliance with ...
|
|
|
BioClinica, Inc.
|
Oncology & Clinical Trials in the 21st Century
Functional challenges aside, electronic data capture can improve cancer clinical trials.
Oncology compounds comprise about one third of the development projects in the pharmaceutical and bio-tech industry (see Figure 1). The features of oncology projects, while not unique to this therapeutic area, do create unique challenges and opportunities in ...
|
|
|
BioClinica, Inc.
|
Electronic Data Capture (EDC) systems should be more than just a means to an end. Quality EDC systems can enable the entire clinical trials information management process. However, if the system enables, it is the data managers who drive. They are burdened with designing processes to make the transition from paper to EDC efficient while maintaining the integrity of the data. And while such ...
|
|
|
|
