samedan logo
 
 
spacer
home > ict > winter 2018 > protected and prepared
PUBLICATIONS
International Clinical Trials

Protected and Prepared

The European clinical research industry is in a period of great uncertainty. As it reckons with current trends – such as a decline in favourability as a clinical trial destination in favour of the Asia Pacific (APAC) region and other geographies – it is simultaneously bracing itself for other changes on the horizon. These upcoming changes are largely regulatory in nature; new regulations are related to advanced therapy medicinal products (ATMPs) and medical devices, which could both add and relieve headaches for researchers (1). Also, the new Clinical Trial Regulation is coming in 2019. Furthermore, after Brexit takes effect that same year, the UK may exempt itself from the Regulation, possibly creating complexities and uncertainties both there and in the post-Brexit EU (2).

Then there is the Greater Data Protection Regulation (GDPR): a vast set of rules and guidelines aimed largely at securing the personal data of EU citizens stored and processed online. While designed for the protection of Europeans, the effects of the GDPR are by no means limited to Europe: EU nationals anywhere in the world are protected by the new law – the personal data of a German citizen living and working in Australia, for example, would be covered – lending it significance on a global level. Given its breadth and its imminence (the law is set to take effect in May of this year), it behooves one to examine the context from which it emerged, as well as how the clinical research industry falls within its scope. Indeed, clinical research and the healthcare industry, at large – which stores massive quantities of personal data in formats such as electronic medical records and clinical trial databases – is bracing for the impact of the GDPR on its operations. What events set the stage for the GDPR, how will it affect Europe’s status as a clinical trial destination, and how can organisations ensure compliance?

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Mike Novotny is the founder and CEO of Medrio – a provider of cloud-based electronic data capture, eSource, and ePRO tools for clinical trials. Mike applies 20 years of experience in research and software to his eClinical Software-as-a-Service vision.

Nick O’Brien leads content marketing efforts at Medrio. At the company, he spearheads co-marketing initiatives, such as complimentary case studies with customers, and creates and commissions content for marketing campaigns. He brings years of experience in copywriting and blogging to his role and holds a BA from Kenyon College, US.

spacer
Mike Novotny
spacer
spacer
spacer
Nick O’Brien
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
More info >>

 
Industry Events

SCOPE Europe: Summit for Clinical Ops Executives

16-17 October 2018, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clin ops execs, functional heads, category managers and those responsible for the planning and management of clinical trials in Europe and the Rest of the World.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement