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Current Topics in Orphan Drug Development

December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Regulatory AffairsMedical Writing, Drug Development Consulting

Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases, INDs, preparation for pre-IND meetings, and the submission and maintenance of INDs.  But in October 2018, the FDA released new draft guidance outlining best practices for early drug development and pre-IND meetings for rare diseases.  Given the near-perfect cross-over potential, we thought this was a sign that it was time to review the guidance, as well as rare diseases as a whole.  So in the interest of appeasing the fates, let’s get this show on the road!

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IMPACT Announces New Medical Writing Fellowship Program

RESEARCH TRIANGLE PARK, NC: 9 November 2018 – IMPACT is pleased to announce our new Medical Writing Fellowship Program, which started 01 May 2018! This program is for professionals looking to gain experience in the medical/regulatory writing field. Fellows are exposed to a variety of regulatory documents related to the clinical development of investigational and marketed drugs and biologics.

This full-time fellowship program runs for approximately 9 months of each year and hosts 2 to 4 fellows per class. Accepted fellows receive a competitive salary and our standard benefit package during their time at IMPACT.

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Pro Tips for Protocol Writing

September 28, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Medical Writing Services

Great news; your team has been given the green light to conduct a new clinical study with your favorite compound!  It’s what you’ve been waiting to hear, and now it’s time to seize the opportunity and run full steam ahead!

But first, you have to write a protocol.  The basic structure and content of a protocol are described in the International Council for Harmonisation Good Clinical Practice E6 guideline.  As you would expect, protocols should ultimately outline and justify the planned clinical study.  The type of information presented in protocols includes background information, trial objectives and assessments, trial design, subject selection and treatment, and a brief overview of the planned statistical analyses.

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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.

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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!

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