Experience. Integrity. IMPACT.
What We Do

Meredith Latino, PhD Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 18 Oct 2017 – In September 2017, Meredith Latino, PhD was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Meredith joined IMPACT in December of 2012 as a Clinical Research Scientist and worked primarily with one of our strategic partners helping to coordinate the proper compilation of clinical study report appendices. After spending several years in that role, Meredith increased her medical writing responsibilities and quickly developed into a very talented author. In her role as a Senior Clinical Research Scientist, Meredith contributes to an assortment of documents (eg, clinical study reports, Investigator’s Brochures, and New Drug Applications) across a variety of therapeutic areas. In addition to her writing responsibilities, she has become a dedicated, knowledgeable mentor to our newer writers – and is always willing to go the extra mile to help them succeed.

Continue reading

RAPS Regulatory Convergence 2017: A Recap

October 11, 2017 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

The Regulatory Affairs Professionals Society (RAPS) held another successful annual meeting (or “Regulatory Convergence” as it’s called) last month. This year’s Convergence was held at the Gaylord Resort at National Harbor on the DC Waterfront and offered more than 70 educational sessions presented by over 200 expert speakers from around the world. In addition, 135 companies, offering a wide range of regulatory services and solutions, were in attendance in the exhibit hall.

Continue reading

The Importance of Style…in Regulatory Documents

September 7, 2017 | Ann Brown, Document Services Manager | Regulatory Operations

When I think of style, the first thing that comes to mind is fashion. Being stylish is to wear clothes that are becoming to your size and shape (you look good!) and are functional, that is, they keep you warm in winter and cool in summer. But, style goes beyond clothing or other things like interior design, automobiles, architecture, etc.

In the world of regulatory writing, how your document presents and how it performs are critically important if it is to meet the rigorous standards of electronic submissions to worldwide regulatory agencies.

Three Tenets of Style

Basically, there are 3 important tenets of style when it comes to regulatory writing:

  1. follow a style guide,
  2. have authors trained in the use of Microsoft Word and its associated templates, and
  3. use well-designed templates that contain built-in styles.

In this post, I will concentrate on the importance of well-designed templates and their subsequent impact on an electronic submission. Style guides and training will be covered in a future post. Stay tuned!

Continue reading

IMPACT’S Making an IMPACT Initiative Celebrates the First Half of 2017

RESEARCH TRIANGLE PARK, NC: 29 August 2017 – In the first half of 2017, IMPACT’s employees continued their generous efforts via the Making an IMPACT community service initiative. Together, we held several donation drives for various charities, as well as our annual March Madness fundraiser.

IMPACT Collects Books for Book Harvest

In January, Lena Randhawa (pictured to the left) organized a book drive to support Book Harvest. Book Harvest provides books to children in need and engages families and communities to promote children’s lifelong literacy and academic success.

IMPACT employees collected 404 books! This year, Book Harvest was able to shatter their previous book collection record and collect over 48,000 books!

 

 

Continue reading

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