News and Press Releases

EMA Offers Updated Draft Guidance on Human Clinical Trials for Cancer Drugs

The European Medicines Agency (EMA) on Tuesday published new draft guidance on the evaluation of anticancer medicines in humans that covers all stages of clinical development. The guidance, which is available for comment through 15 September, delves into the development of treatments for malignancies, including “drug resistance modifiers or normal tissue protective... read more

Five Years of Cancer Drug Approvals: Pricing, Novelty and Improvement

The last five years have been exceptionally busy in terms of oncology drug development. Two interesting articles that reflect back on this period of time were recently published. The first, which I consider here, is “Five Years of Cancer Drug Approvals: Innovation, Efficacy, and Costs” by Drs. Sham Mailankody and Vinay Prasad (JAMA Oncol. 2015; 1(4):539-540). This paper considers whether or not all of the recently approved cancer drugs merit their... read more

EU CTR 536/2014: Key Considerations For CROs And Sponsors

Based on the recognition that the system might have hampered clinical research, the European Parliament and Commission published Regulation 536/2014 in April 2014, which contains significant changes in regards to the application process, definitions, responsibilities, reporting during and after the trial, and clinical trial... read more

Clinipace Worldwide co-founders named E&Y Entrepreneur of the Year finalists

Clinipace Worldwide, a global digital CRO, has announced Jeff Williams, CEO and co-founder, and Chris Porter, president and co-founder, have been named one of three finalists in the Health Care & Life Sciences category of the Ernst & Young Entrepreneur Of The Year 2015 Southeast Program, which includes Alabama, Georgia, North Carolina, South Carolina and... read more

Clinipace Worldwide Co-Founders Named E&Y Entrepreneur of the Year® 2015 Southeast Finalists

MORRISVILLE, N.C. (Business Wire) May 6, 2015 – Clinipace Worldwide, a global digital contract research organization (dCRO), today announced Jeff Williams, CEO and co-founder, and Chris Porter, president and co-founder, have been named one of three finalists in the Health Care & Life Sciences category of the Ernst & Young Entrepreneur Of The Year 2015 Southeast Program, which includes Alabama, Georgia, North Carolina, South Carolina and Tennessee. The prestigious awards program recognizes entrepreneurs who demonstrate excellence and extraordinary success in areas such as innovation, financial performance and personal commitment to their businesses and communities. Williams and Porter founded Clinipace in 2003 as a software company and have since built the first global full-service digital CRO. From 2012 to 2014, the company experienced a growth rate of 348% and added more than 450 jobs. In addition to its strong organic sales growth, Clinipace has had six acquisitions in as many years, including the most recent closing of its merger with Accovion, a European full-service CRO headquartered in Frankfurt (Eschborn), Germany. “We are honored to be recognized as finalists for the Southeast region of this prestigious award,” said Williams. “Clinipace was built on the fundamental belief of improving clinical trial operations in terms of quality and cost, and we’re proud to say this is the foundation upon which Clinipace has grown to nearly 1,000 employees. It has been a truly remarkable journey that would not be possible without the dedication and expertise of our employees.” “It is truly exciting to be recognized for our entrepreneurial spirit, which extends far beyond Jeff and myself and can be seen throughout the company,” added... read more