home > ict > summer 2019 > outsourcing trial applications
International Clinical Trials

Outsourcing Trial Applications

                                                Image from Shutterstock

The complexities and national nuances of the competent authority (CA) clinical trial application (CTA) process across EU countries often lead sponsors, especially those based outside the EU, to outsource CA CTA submissions to service organisations within the EU. The decision to outsource gives rise to several items for the sponsor to consider. What outsourcing model will be the best fit? How will trial-related legal requirements be met? Do core trial documents adhere completely to EU guidance? How will the timing of each CA submission fit in with any other planned regulatory activities in the EU? What will be needed for the UK post-Brexit? These considerations need to be addressed in good time to facilitate an efficient submission process and correspondingly rapid approvals for clinical trials.

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 author

Paul Carrodus is Director of Regulatory Services at TMC Pharma Services Ltd. He is a regulatory affairs professional with over 14 years’ EU regulatory experience working in major pharma and clinical research organisations. Paul’s expertise spans all aspects of regulatory affairs, from early drug development to post-marketing support, including regulatory strategies, MAAs, and lifecycle maintenance support, scientific advice, orphan drug applications, paediatric investigation plans, clinical trial applications, and medical writing.

Print this page
Send to a friend
Privacy statement
News and Press Releases

Registration Opens for Inaugural HPAPI USA Conference in October

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety.
More info >>

White Papers

Competitive Drive: The Challenges of a Globalised Packaging Industry

Aesica Pharmaceuticals

Packaging is becoming an increasingly competitive and lucrative industry globally. Jeremy Drummond PhD of Aesica Formulated Products looks at the challenges and opportunities this presents.
More info >>

Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India forhigh quality, low   cost pharma solutions, CPhI & P-MEC Indiais the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India’s pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement