Experience. Integrity. IMPACT.
What We Do

Publishing an eCTD Clinical Study Report: ICH E3

August 15, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

Because IMPACT writes and publishes so many CSRs, we get a lot of sponsors asking us questions about how CSRs should be published. This tells me that there’s a lot of confusion about CSR requirements and, in my opinion, some of that confusion stems from ICH E3. I thought I would use Ilana Dew’s recent blog post about ICH E3 as a jumping-off point from which to talk about what that document means to us as publishers.

In her post, Ilana discussed the medical writer’s perspective on transparency and flexibility in E3. I’m really glad she brought up flexibility because as a publisher advising sponsors about CSR publishing, the first thing I tell them is that ICH E3 is a guideline, not a guidance.

In fact, in 2012 the ICH E3 working group even released a Q&A document to state this very clearly because sponsors were asking about it. Thus, we do our best to comply with the spirit of E3 while also meeting the needs of electronic submissions.

Continue reading

CORE Reference for ICH E3 Clinical Study Report Authoring: Evolving with the Times

July 13, 2017 | Ilana Dew, PhD, Senior Clinical Research Scientist | Medical Writing Services

You may be a seasoned regulatory medical writer who has authored dozens of Clinical Study Reports (CSRs) and can recite the contents of the 1995 International Council for Harmonisation (ICH) E3 Guideline on the structure and content of CSRs with your eyes closed.

Or, you may be new to the profession. You’ve seen our blog series on getting started in the field, you have accepted a position in regulatory medical writing, and came here looking for some direction on how to interpret the ICH E3 recommendations and put together your first CSR.

Whether you fall into the former description, the latter, or anywhere in between, there’s something new that you are going to want to see.

It’s the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual, created to guide authors toward best practices for creating CSRs with new clinical trial transparency and disclosure regulations in mind.

Continue reading

Most Common Advice We Give First Time NDA/BLA Submission Teams

June 14, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing & Corporate Communications | Medical Writing Services

Throughout the years, our staff at IMPACT has worked with many clients on marketing applications (large and small) across a variety of therapeutic areas. Each one comes with its own unique challenges, but the most interesting (and often the most exciting) are those where the client is working on a submission for the first time.

Such client teams can represent a small company bringing their first drug to market, or a first-time team within large pharma. Though their corporate atmospheres may differ, the challenges they face on their first submission can be similar.

Without further ado, here are the most common 5 pieces of advice we give to first time submission teams. [Reader’s Note: In this post I use the term “submission” to mean a marketing application (eg, NDA, BLA, MAA).]

Continue reading

Dispelling Misconceptions: Converting from Paper to eCTD Submissions

May 23, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

Over the years I’ve heard a whole bunch of misconceptions and misunderstandings about making the change from paper submissions to eCTD. Since the deadline to convert NDAs, ANDAs, and BLAs has recently passed (May 5th, 2017) and the deadline for INDs and DMFs is now a little less than a year away (May 5th, 2018) I thought I’d address some of them.

Continue reading

Key Considerations for the Upcoming Mandatory eCTD Requirement

April 27, 2017 | Kathy Elks, Principal Consultant and Jeff Golden, Associate Director | Regulatory Operations

People who work in Regulatory Affairs, and especially those in Regulatory Operations, are well aware of the fact that it is less than a month before eCTD submissions will become mandatory. Starting on May 5th, all NDAs, ANDAs, and BLAs that are submitted to the FDA must be filed in eCTD format.

Many companies have already transitioned to eCTD submissions. However, for those companies that have not transitioned to eCTD submissions, we have some things to keep in mind regarding the requirement.

Continue reading