Experience. Integrity. IMPACT.
What We Do

Getting in Tune: The ICH Process of Harmonizing Guidelines

August 16, 2018 | Cheryl Ainslie, PhD, Clinical Research Scientist II  │ Regulatory Affairs Services

Image from kisspng.com

“The only constant is change,” commonly attributed to the Ancient Greek philosopher Heraclitus, is as true today as it was in 500 BCE.  In the global industry of drug development, the conduct and reporting of clinical trials may change to a small degree with every new study proposed.  But what happens when there is growth or momentum for change that could impact the industry as a whole?

The Role of ICH

In a previous post, Ilana discussed the International Council for Harmonisation (ICH, previously called the International Conference on Harmonisation) guideline for clinical study report authoring, Efficacy Guideline 3 (E3).  The goal of the post you are reading is to take a step backward and explain how ICH guidelines are proposed, evaluated, and (possibly) adopted.  This process is key to understanding the function and operation of ICH to ensure that drug development is highly efficient and scientifically sound.

Created in 1990, the ICH of Technical Requirements for Pharmaceuticals for Human Use comprises experts from regulatory authorities and the pharmaceutical industry in the EU, US, and Japan.

Continue reading

IMPACT’S Making an IMPACT Initiative Celebrates the First Half of 2018

RESEARCH TRIANGLE PARK, NC: 26 July 2018 – In the first half of 2018, IMPACT’s employees continued their generous efforts via the Making an IMPACT (MAI) community service initiative. Together, we held several donation drives for various charities, as well as our annual March Madness fundraiser.

IMPACT Spreads the Love on Valentine’s Day

In February, the MAI team wrote valentines to all our fellow IMPACT colleagues to show how much we appreciate and value the unique contributions of each employee! The MAI team gave personalized notes to every IMPACT employee along with a goodie bag filled with treats.

In addition, the MAI team unveiled The Kindness Calendar: a wall-hanging calendar that contains laminated cards describing acts of kindness. Our particular calendar was designed for IMPACT employees to foster our connection with each other and promote camaraderie.

IMPACT’s 5th Annual March Madness Prizes Go to 3 Worthy Charities

In March, IMPACT hosted our 5th annual March Madness NCAA basketball charity bracket fundraiser! Many thanks to the IMPACT employees, family members, and friends who participated; together we raised $630! Following a matching donation from the MAI team, we were able to donate a total of $1500 to the top 3 charities!

Continue reading

Helpful Tips I Learned at the AMWA Carolinas Spring Conference

July 10, 2018 | Caroline Drucker, PhD, Clinical Research Scientist II  │ Medical Writing Services

In May, the Carolinas Chapter of the American Medical Writers Association (AMWA) held its annual spring conference at the Friday Center in Chapel Hill, NC. With this location convenient to Research Triangle Park, I was fortunately able to attend, meet other medical writers in the area, and learn about an array of topics from the 6 speakers and other attendees. The subjects ranged from the technical (efficient use of Microsoft Word) to the writing process (strategies for focused authoring, approaches for efficacy and safety summaries in marketing applications, and editing your own work) to the “softer” skills involved in medical writing (such as interpersonal interactions and working from home).

Continue reading

The Why, What, When, Who, and How of Quality Control (QC) of Medical Writing Deliverables

May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │ Medical Writing Services

Quality control (QC) is a term that applies across many industries. Within the field of regulatory medical writing, QC refers to the process of ensuring the quality and accuracy of a final medical writing deliverable.

In this post, I hope to answer many of the questions that our clients often ask us, such as: Why QC? What does QC entail? When should it occur? Who should QC?

Why QC?

The “why” of QC is straightforward – our goal is to deliver a document of the highest quality to our customers and it’s required by the guidance set forth by the International Council for Harmonisation (ICH):

“The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.” ICH E6: Guideline for Good Clinical Practice

The “who, what, and when” of QC are a little harder to define. What is QC? When should QC occur? Who should QC? As a regulatory medical writer who both writes and QCs on a daily basis, as well as leads the Quality Control department at IMPACT, I’m hoping I can shed some light on these questions.

Continue reading

Ready to Submit Your Initial IND?

April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND activities. Continue reading this post to understand the process of submitting an initial IND and the subsequent IND-related steps to take as you proceed towards your marketing application.

Let us start with …

IND components

Continue reading