spacer
home > ict > autumn 2016 > changing face
PUBLICATIONS
International Clinical Trials

Changing Face

The investigational study of pharmaceutical and biotechnology products is rapidly becoming a global endeavour. While the development of drugs has necessitated material supply such as active pharmaceutical ingredients, and with drug manufacture gradually moving from traditional developed countries like the US or European member states to emerging ones such as China and India, we are now witness to a geographic shift for the implementation of these trials.

International Range


In past years, a multi-country study might have involved only the US and developed European countries. This would require multi-language labelling and contending with the multitude of country-specific regulatory requirements, but would be limited to a handful of countries with advanced healthcare infrastructures to support the needs of a trial.

In today’s market, investigational studies are spreading to many emerging markets – including Russia, Ukraine, Eastern Bloc countries, Latin American countries such as Brazil and Argentina, as well as Central America. There is also a rise in conducting trials in the Asia-Pacific region, with significant population growth and rapidly developing healthcare infrastructure in dense urban areas.

It is, therefore, appealing to carry out investigational drug studies in the Asia-Pacific region, but this does come with risks and challenges depending on the location of the trial sites and the laws governing the country where the study is to be administered. For example, the regulatory requirements in Japan can vary significantly to those in regional neighbours like China, Malaysia, the Philippines, Taiwan, Singapore, South Korea and others. Every country needs to be evaluated independently for its attractiveness and its relative regulatory and logistical risk, as each is distinctly unique.

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.

spacer
Rich Nelson is the Distribution Services Manager for PCI’s Clinical Services group, working with clients to provide seamless global distribution of their investigational products. Rich joined PCI in 2012 after seven years with Fisher Clinical Services, having supported both global distribution of investigational products as well as interactive voice response system solutions. He is certified in Lean Six Sigma/continuous improvement, and is a graduate of Monmouth University in West Long Branch, New Jersey.
spacer
Rich Nelson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Surge of Indian biosimilars market forecast in 2019

16th April 2019: New data from CPhI shows that, despite ongoing reputational challenges, India’s biologics market is set for robust growth in 2019 driven by biosimilars production. The India specific findings from CPhI’s bio league tables predict strong ‘bio growth potential’ in India throughout 2019 in the build-up to the 13th edition of CPhI India 2019, which will take place at the India Expo Centre in Delhi NCR.
More info >>

White Papers

Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models

DrugDev

For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality. One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
More info >>

 
Industry Events

DIA 2019 Global Annual Meeting

23-27 June 2019, San Diego Convention Center

DIA 2019 is more than just a meeting: it’s where brilliant minds come together to create solutions. Thousands of global innovators will convene to engage in discussions on today’s hottest topics in the life sciences field, propose ways to combat daily challenges, and network to create lasting connections.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement