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The Ins and Outs of INDs

February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot of questions about the best way to prepare for an Investigational New Drug (IND) submission. So we’ve decided to tackle those questions in a series of blog posts. In this introductory post, we’re going to focus on some background information that will help explain the overall purpose and requirements of an IND.

Let’s start with . . .

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

RESEARCH TRIANGLE PARK, NC: 24 January 2018 – In the second 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 Season of Giving series of mini-events.

IMPACT’s 4th annual Crayons2Calculators Fill that Bus! drive
In August, Beth Pultorak spearheaded the 4th annual Crayons2Calculators “Fill that Bus!” drive. Crayons2Calculators helps more than 10,000 local children in need by providing their teachers with basic school supplies and educational tools.

IMPACT employees supported Durham public schools by donating 4 large bins of supplies to Crayons2Calculators’ annual Fill That Bus! event!

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Tips for Effective Meetings – Getting the Most out of the Time Spent Together

December 20, 2017 | Elaina Howard, PhD, RAC, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services

Have you recently tried to schedule a meeting with your coworkers and found it difficult to find a time when everyone is available? If this is the case, then you know how precious the time together can be and how important it is to have effective and efficient meetings.

To put time spent in meetings into perspective, I often remind myself that while in a meeting, you are really using that time spent multiplied by the number of people in the room. That can be a lot of pressure to make good use of this time!

Not to worry, though; in this blog post, I’m going to suggest general meeting efficiency tips and I will also detail how I aim to get the most out of two common types of meetings for regulatory medical writers.

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IMPACT Employee Honored as the “Triangle’s Finest” by the Cystic Fibrosis Foundation

Research Triangle Park, NC: 7 December 2017 – This fall, IMPACT’s Rachel Cohen participated in the Cystic Fibrosis (CF) Foundation’s annual “Triangle’s Finest” event, a program for Triangle-area men and women committed to professional development and personal growth through fundraising and awareness.

On November 3rd, 4 individuals were honored at the Brewer’s Ball celebration where over 200 attendees gathered at Bond Brothers Beer Company in Cary to celebrate the Triangle’s Finest and benefit the CF Foundation. In addition to Rachel, Caroline Teachey (Chiesi USA), Sarah Stokes (Gluten-Free with Sarah B), and Charles Webb (Starbucks Coffee) were honored by the CF Foundation.

On a gorgeous fall night amidst a casual environment including craft beer, tasty food from local vendors, and auction items galore, Rachel (left) was recognized as the “Triangle’s Finest Young Professional of the Year” after raising the highest amount of the 4 honorees.

In 7 weeks, Rachel raised over $8000 by online fundraising, corporate sponsorship, co-hosting a donation Yoga for Runners class with Arrichion Durham, and receiving a portion of proceeds from events held at Bull Street Gourmet & Market and Wine & Design Durham.

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Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

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