Clinical Development from pre-IND to NDA

As a CRO, Health Decisions often performs work at different stages and in different disciplines of clinical development. Such tasks include strategic consulting, program planning, protocol development and other biostatistical consulting, project management and clinical monitoring of clinical trials (phase 1 – 3 clinical trials for drugs and PMA and 510(k) studies for diagnostics and other medical devices), data management, quality management, regulatory services, medical writing, and so on. But in clinical development, the whole is much greater than the sum of its parts – it is ultimately availability of a new product that improves healthcare and people’s lives.

That is why we take particular pride in those instances when we have contributed to clinical-development programs from the very beginning. In the case of drug programs, this means supporting development from pre-Investigational New Drug (Pre-IND) meeting, through the pre-IND meeting, and on through protocol development, execution of clinical trials, statistical analysis and the submission of a New Drug Application (NDA) for marketing approval. Over the last 4.5 years, we have had the pleasure of helping Evofem, Inc., advance the clinical development program for Amphora, an investigational non-hormonal contraceptive gel, from pre-IND days through an NDA filing in late June 2015 and FDA acceptance of the filing in September 2015 for review.

Glancing Backward, Focusing Forward

We have celebrated previous development milestones in the Amphora program, most recently database lock for a 3,389-subject global phase 3 clinical trial. We will continue to support Evofem through FDA review of the Amphora NDA – there is more work to be done to ensure that Evofem achieves its development goals. Nevertheless, we would like to pause for just a moment to reflect on what the Evofem team and more than 40 members of the Health Decisions staff have collectively accomplished, along with a network of Principal Investigators and Study Coordinators, over the last 4.5 years.

Sheer quantity of work performed or information generated can never capture the significance of a new drug. Furthermore, quality rather than quantity is paramount in clinical development. However, quantitative measures do demonstrate the effort that those engaged in a clinical development program have contributed to increasing our understanding of a new drug’s efficacy and safety. In that spirit, we would like to report that the NDA submission that Evofem and Health Decisions prepared for Amphora contained:

  • 1,072,224 pages
  • 14.2 GB of data
  • 7,223,029 links

We take pride in these numbers, but the Health Decisions team for the Amphora program is back at work, focused on next steps. Onward!

Jim Higgins


James E. Higgins photoJames E. Higgins, PhD, Executive Vice President & Director of Biometrics at Health Decisions, has been involved in NDA submissions for products in therapeutic areas including CNS, contraception, hormone replacement and cardiovascular. At Health Decisions from 1995 to present, Dr. Higgins has played a leading role in dozens of IND/IDE studies, 23 in contraception alone.