| Welcome to the May-June 2018 edition of The Protocol Link Newsletter! This edition of our newsletter looks to bring you up-to date with noteworthy news, introduces you to the newest Protocol Link team member, showcases industry articles authored by our own Protocol Link employees, and concludes with A Word From Our Staff. We hope you enjoy this edition of The Protocol Link Newsletter! |
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Protocol Link Welcomes Scott Good!
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 Protocol Link is proud to announce the arrival of Scott Good as Senor Director!
Scott brings 30 years of operations, continuous improvement, and technical leadership experiences in the pharmaceutical, medical device, and biotechnology industries, having served as Site Head within each of these disciplines.
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FDA Announces Streamlined Pathway for Clearing Devices
Authored by
Christine Shumard-Sauer, Ph.D.
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The Food and Drug Administration (FDA) issued a recent draft guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, which outlines the agency's approach to clearing moderate-risk devices through an expanded version of the FDA's established Abbreviated 510(k) program. The new approach will allow medical device manufacturers to compare the performance of new devices to criteria defined by FDA rather than measuring them to a "predicate" device to demonstrate that the new device is safe and effective.
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Increasing Performance in Pharmaceutical Manufacturing
Authored by
Ankit Patel
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When something goes wrong in the pharmaceutical process supply chain which can impact the quality of a product, the company is expected to investigate the incident to determine the root cause, correct the issue, and prevent recurrence. According to a survey of BioPhorum member companies, more than 50% of the time, the root cause of deviations is traced back to a human error, indicating human error in the pharmaceutical industry is pervasive.
However, simply claiming human error as root cause and retraining on the same SOP does not eradicate the problem.
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Authored by
Lokesh Kukreja, Ph.D.
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 The U.S. Food and Drug administration (FDA) launched a Clinical Data Summary Pilot program earlier this year to bring more transparency around how the FDA reaches decisions on market approvals for new drugs. The agency's current review on clinical trials collects information in the system as drug approval action packages. The information in the action packages is pulled in from different sections of the sponsor's application, but does not provide a complete summary of the results of any given study. This makes it difficult for academic researchers, regulators in other agencies, and other stakeholders to gain an in-depth understanding of the studies supporting approval.
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Protocol Link Has Gone the Distance
Q1-20
18 finds Protocol Link entering its 22nd year of operation. This milestone date happens to correspond with my personal 20th year anniversary with the company, providing me a unique perspective on the Service, Dedication and Support that Protocol Link has provided to you--our Colleagues, Clients and Friends.
To help illustrate the commitment Protocol Link has made to our Clients, I thought about the many locations we have visited. I performed a quick "back-of the envelope" calculation and estimated how many visits we made to each remote client location (US and Rest of World)*. Using a combination of Google and Excel, I calculated the distance (in miles) from our office headquarters in Vernon Hills, Illinois, to each location. Based on round-trips (no one has ever failed to return), I calculated the total number of miles our team has traveled in support of our clients:
2,437,644 miles! Or 97.8 times around the world...
5.1 trips to the moon and back!
The next time you have an opportunity to chat with one of Our Staff about how Protocol Link can go the distance for you, ask them about their travels. I am sure they will have an interesting road-story to share.
Dan Hoch, Ph.D.
Vice President, Protocol Link
*Actual data estimates available upon request - call me at 847-549-0390 to discuss.
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Protocol Link recently launched two new service categories showcasing our capabilities in
Project Management and Device and Diagnostics! These services have always been at the core of our expertise. The new services rollout was an opportunity to highlight and freshen what we've already been providing to our clients for the past 22 years. |
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Copyright © 2018. All Rights Reserved.
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