Clinical Trials in the USA for Ex-USA Companies

Dr Michael Silverman of BioStrategics Consulting Ltd discusses his role in helping several ex-USA companies conduct their clinical trial development programs in the USA under USA regulations and in USA facilities.

Over the last 20 years of consulting for, and advising, pharmaceutical and biotechnology companies, helping define their clinical development strategies, create their clinical study protocols, and oversee their implementation, I have had the privilege to advise several companies based overseas, specifically in Europe, Asia, and Oceana.

BioStrategics Consulting Ltd has provided strategic, management-level clinical development consulting services on virtually all types of therapeutic products in all phases of development and across most therapeutic areas, with particular concentration in, oncology/hematology, autoimmune/inflammatory disease, infectious disease, rheumatology, dermatology, and ophthalmology.

The specific help provided to these ex-USA companies has included, but is not limited to:

  • Providing strategic input on product development plans,
  • Designing a phased clinical trial evaluation plan,
  • Preparing Investigational New Drug applications,
  • Preparing for and attending US FDA meetings,
  • Developing clinical trial protocols,
  • Researching clinical end points and regulatory precedents,
  • Evaluating, selecting, and overseeing CROs,
  • Evaluating and selecting potential clinical trial sites,
  • Project management of the clinical trial plan,
  • Identifying and organizing input from thought leaders and potential investigators,
  • Setting up, facilitating and reporting on expert panel meetings,
  • Analyzing clinical data, and preparing post study reports for internal and external use, and
  • Preparing clinical data for submission as part of a NDA, PLA, BLA and other USA regulatory filings, along with necessary face-to-face representations with various authorities.

Furthermore, BioStrategics Consulting Ltd has often been able to assist client companies achieve their goals through its global network of experienced drug development professionals (such as biostatisticians, medical writers, clinical operations personnel, and clinical contractors) as well as academic thought leaders and clinical investigators.

If yours is an ex-USA company looking for advice or help with your clinical program in the USA, please do not hesitate to contact me by email, phone or comments to this blog, by clicking on this link.

I would be delighted to hear your thoughts on these issues, your approaches, or anecdotes about decisions you have faced in similar circumstances. To make comments or ask questions, click on this link.

For more information: go to my website or send me an email to

Copyright © 2011 BioStrategics Consulting Ltd.


About BioStrategics Consulting Ltd

BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical and biotechnology industries
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