home > ict > winter 2020 > imp integrity
International Clinical Trials

IMP Integrity

As trials become more global in nature, especially as they enter emerging markets, challenges intensify. To respond, pharmaceutical companies need to be thorough in their planning to be compliant and ultimately ensure patient safety. Today, we are seeing new and different regulations proliferating from global regulatory authorities. Long-concerned with GMP, regulators have been turning their attentions towards transportation processes and investigational medicinal products (IMPs) in the context of study conduct. This is a place where numerous GxP principles converge: GMP is a given, but it also includes the rules surrounding clinical excellence (GCP), good distribution (GDP), and storage practices (GSP). Cumulatively, these affect every aspect of the clinical supply chain.

Ultimately, these processes are critical because they ensure a product arrives in a useable condition in order to further the goals of the clinical trial and honour the safety of participants.

Maintaining Integrity in Transit

Many of today’s IMPs require temperature control, especially in the realm of oncology and large molecule research. With clinical trial material, where knowledge of the stability profile is rapidly changing, there are risks involved throughout the transportation chain (usually outsourced and using generic, less well-controlled routes). It is critical to be aware of these risks, and a correctly managed clinical supply chain is paramount.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

About the authors

Vincent Santa Maria has over 30 years of experience primarily in pharmaoperations and services, currently Vice President of Clinical Trial Supplies and Logistics at Parexel International. Prior to joining Parexel, Vincent was the Global President at Bilcare Global Clinical Supplies (now Sharp Clinical Services) and President and Managing Director at Almedica Services Corporation (now Catalent). In his previous experience, Vincent served as Chief Financial Officer at various start-up companies and an Italian pharma company. He is also a certified public accountant in the state of New Jersey, US.

Tony Heeley has over 30 years’ experience working at global pharma companies and CMOs, currently Associate Director of Production Services, supporting label manufacture and production planning and documentation at Parexel International. Prior to joining Parexel, he worked in the clinical supply chain in Shire and Wyeth. Previously, he held positions at Almedica Technology Group, focused on the development of labelling and supply chain systems, identifying client requirements and Almedica Europe, with responsibility for label management, production services, and clinical shipments. He is a registered pharmacist in the UK.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Signant Health invests for growth with the opening of its new Philadelphia-area office

PHILADELPHIA, PA – February 18, 2020: Signant Health, an industry-leading clinical research technology and solutions company, is proud to announce that it has officially opened a new, leading edge office facility in Blue Bell, Pennsylvania. Construction on the new office, which is the largest workplace in Signant Health’s global network, completed in February 2020.
More info >>

White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
More info >>

Industry Events

Clinical Operations in Oncology Trials West Coast

21-22 April 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement