This website uses cookies

This website uses cookies to ensure you get the best experience. By using our website, you agree to our Privacy Policy

International In-house Counsel Journal logoInternational In-house Counsel Journal logo

'The Past, the Present, and the Future … Clinical Trials and the Contract Research Organisation (CRO)'

Abstract

In 2016, Clinical Trials globally are performed to ensure safe and efficacious treatment which meet ethical principles, but will these principles meet the challenges of the future? To understand how and why clinical trials are performed today and will be in the future it is essential to understand the past and the thorny path trodden in the performance of clinical trials. Overarching any clinical trial is a person’s right and ability to consent. The issues surrounding the urgent need for effective efficient treatments balanced by the risk/benefit analysis of the efficacy and efficient treatments is a universal global concern. The ultimate goal of any successful treatment belies a history of divergent checks and balances to reach the constant moving pyramidal spike of success and each end point creates a giant leap forward to the benefit of mankind. But the rapidly escalating cost of clinical trials has caused the pharmaceutical and biotech industry to seek new ways to off-set the burgeoning costs to reap financial reward and fund future trials of new innovative medicine, and the introduction of outsourcing through Contract Research Organisations (CROs). All of these factors in the past have created a plethora of legal and industry challenges. The law is always one step behind the advance of science, and ultimately the industry and the law must partner together to meet these challenges to strive forwards. The focus of this paper primarily pertains to events affecting the UK and USA.

Read Paper

Author

Portrait image of Helen Fovargue
Helen Fovargue
Assistant General Counsel, Iqvia, UK

Helen Fovargue is a Solicitor, England and Wales, Attorney-at-Law, New York. Worked in private practice in London and New York before moving in-house to specialise in the Life Science industry (biopharmaceutical product development and commercial outsourcing services) 11 years ago. Currently working as the lead dedicated lawyer to Q Squared Solutions (global clinical trial testing laboratory) for the past 1.5 years, which is a JV between IQVIA and Quest Diagnostics. Global Legal Subject Matter Expert (SME) Clinical Trial Testing Laboratories, Early Clinical Development (phase1-2a), EMEA legal lead Vendor corporate enterprise agreements.

Company

Iqvia logo

Iqvia

IQVIA is a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 50,000 employees.

Related Papers

Contract Mapping: Taking the Diligence Room and Contract Transparency to the Next Level
Traditional methods of tracking contracts miss the opportunity to provide meaningful context and insight relating to the contracts of the company to management, the board members, auditors, and investors. ...Read more
Portrait image of Gunnar Wieboldt
Gunnar Wieboldt
Former SVP, General Counsel, Vestaron Corporation, USA
Patent Strategies for Attenuated Pathogen Vaccines
Malaria is a major health concern for people traveling to and living in malaria-endemic areas, causing 249 million clinical cases and 608,000 deaths in 2022, numbers essentially unchanged over the...Read more
Portrait image of David Dolberg
David Dolberg
Senior Director of Intellectual Property, Sanaria Inc., USA
Negotiating IT Service Contracts – In House v Private Practice Legal Models
I have been privileged to work over my career as a partner in private practice with leading City firms in London and as a senior in-house lawyer in global companies....Read more
Portrait image of Clive Davies
Clive Davies
Senior Counsel and Professional Development Manager Legal & Commercial, UK&I, Fujitsu Services Limited, UK
Ways to Avoid Having your Patents Cellected*
The Court of Appeals for the Federal Circuit caused frustrations when it decided to affirm the U.S. Patent Office’s findings that claims in four patents were unpatentable because they are...Read more
Portrait image of Tom Irving
Tom Irving
Partner, Marbury Law Group, USA
Portrait image of Michelle E. O'Brien
Michelle E. O'Brien
Partner, Marbury Law Group, USA
Portrait image of Xiaoguang Michelle Gao
Xiaoguang Michelle Gao
Associate VP - Assistant General Patent Counsel , Eli Lilly and Company, USA