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Author Archives: Tim Garver

Logistics to Consider When Setting up a Strategic Medical Writing Partnership

June 23, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services

In an earlier blog post, I introduced you to the concept of a strategic medical writing partnership and explained why you might want to set one up for your company. In this post, I’m going to get into the nitty gritty of how to set one up – including what you should consider when establishing a partnership as well as how to keep it going successfully once it has been established.

In our experience, considerations at the start fall into two buckets – business considerations and operational considerations. Let me help explain.

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What is a Strategic Medical Writing Partnership? And Should I Set One Up?

March 31, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services

There are a myriad of terms that refer to the different types of long-term contractual relationships that can exist between Sponsors (including large and small pharma or biotech companies) and service providers (whether they be CROs [large or small] or independent contractors).

IMPACT has been engaged in a variety of different types of arrangements with our clients over the years, but there is one relationship in particular that I want to talk about here: a Strategic Medical Writing Partnership between a Sponsor and a CRO (namely, us).

What is a strategic medical writing partnership, you ask? Let me help explain.

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Planning Your NDA or BLA Submission: It’s More Than a Gantt Chart!

February 25, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services

You’re finally there! You and your colleagues find yourself at the doorstep of being able to submit either a New Drug Application (NDA) or Biologic License Application (BLA) for a compound that your team has been dedicated to for years. The hard work of bringing a new compound to market – and to the patients who need it – is about to pay off. It’s time to begin planning for your submission.

“Submission planning” – what does this encompass exactly? And when and how do you go about doing it?

It’s More Than Just About “Creating Timelines”

The development of a submission plan involves more than just creating detailed timelines, although that’s certainly an important part of it.

Submission plans must be strategic – that is, they need to be both tailored and dynamic. Tailored to fit the anticipated work, resource allocations, and Sponsor work practices (ie, one size does NOT fit all), and dynamic, because things WILL CHANGE along the way that will require periodic “course corrections.”

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Benefits vs. Risks: Telling the Story in the Clinical Overview May be Changing

October 6, 2015 | Tim Garver, PhD, EVP/COO | Medical Writing Services

Are you scheduled to work on or submit a marketing application in the second half of next year? If so, you’ll need to be prepared for some potentially big changes in what’s required when making the benefit-risk argument in your Clinical Overview.

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