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Shortening the Timeline: A Medical Writer’s Guide to Success

Shortening the Timeline: A Medical Writer’s Guide to Success

Written By
25 Mar 2024

25 Mar 2024 │ Christina (Chrissy) Williams, PhD, RAC, Sr Director │ Medical Writing Services


How can we shorten the timeline? Clinical and regulatory medical writers often hear that question on repeat. There’s the obvious answer…provide on-time, high-quality, clean data, and we can brainstorm ideas to shorten the timeline. And then there’s the nuanced answer…it depends. To discover some of our “secrets to success,” keep reading. While the first things that may come to mind are clear writing, appropriate grammar, and lack of typos, what is more important is the expertise and knowledge a medical writer brings in helping teams avoid common pitfalls in document preparation that can affect not only timelines, but also document quality and cost.

Secret to Success #1: Planning

Yes, this is an obvious answer – everyone agrees that planning is important and results in shorter timelines. But, when teams are provided with a document or submission due date, they often don’t dedicate energy to developing a clear understanding of the steps, and associated time, that are needed to get to that due date. A common response is for everyone to jump in and get started, because then it feels like progress is being made. But beware – it is not true progress, and often times this approach results in longer timelines.

How a medical writer can help: Medical writers are experts at timeline development for single documents and submissions that include multiple documents. We understand the steps, and the time needed for each step, to create an efficient, high-quality, cost-effective document. We also advise teams on the development of strategy, because considering overall messaging (and ultimately product labeling) from the beginning of document preparation is key.

How a Syner-G medical writer can help: Syner-G medical writers have developed tools to help teams proactively develop desired messages and identify strategies to ensure those messages are supported throughout the document(s). Having a Syner-G medical writer guide and record these decisions takes the burden off the Sponsor team. This not only reduces the document timeline (reduced drafting time, revisions, and number of drafts), but also saves significant Sponsor team member time (shorter and decreased number of meetings and reviews).

Secret to Success #2: Early and Often Medical Writer Involvement

Time to write a protocol, CSR, IB? Contact the medical writer! When teams are ready to put pen to paper on documents, they know to reach out to a medical writer. But, often, this is too late! A medical writer does more than just write, or, as some might think, copy and paste. Medical writers have a broad skill set – we are keen listeners who can craft arguments based on team discussions, we are adept at helping team members focus and make decisions, and we are skilled at not only synthesizing large volumes of data, but also interpreting the data.

How a medical writer can help: A medical writer who is familiar with the science, regulatory strategy, and team priorities increases the ability to quickly identify and adapt the organization and/or content of a document. If the team is early in discussions for a protocol design, chances are a medical writer may have written up a similar design before and/or know some of the challenges encountered with specific designs or patient populations. Preparing your statistical analysis plan? A medical writer has keen knowledge of what type of analyses and data displays are important in a clinical study report – not just to check the boxes, but to truly be able to answer the key questions for approval and labeling.

How a Syner-G medical writer can help: Syner-G has a large group of medical writers with substantial industry experience, science-based advanced degrees, and RAC certification. Syner-G medical writers don’t only author documents – they are capable of and often contribute to strategy discussions, ultimately becoming trusted partners with the team. The science backgrounds of Syner-G medical writers help guide the team from the early IND stages through to post-submission ad hoc regulatory requests and labeling negotiations. And if the Syner-G medical writer resourced to your project doesn’t know the answer to a team question – someone within the Syner-G team of medical writing experts likely will.

Secret to Success #3: Engaged, On-Time, Consistent Team Involvement

Yes, another obvious answer. But, Sponsor team involvement is key. Team members are busy – many are on multiple projects, multiple indications, and/or multiple drugs, biologics, and/or devices. And that doesn’t even take into account their non-project responsibilities. It’s a lot of work! But, if team members don’t prioritize being involved in strategy discussions, being engaged and reviewing document drafts per the timelines, and attending and participating in comment resolution meetings to discuss team comments, progress and decisions can’t be made. When team members are not engaged, when they ask to extend the review time by a day (or more), or when new team members do their first review at the Draft 2 stage (or later!), chaos often ensues, and the result is extra work (for everyone!), as well as potential delays and increased cost.

How a medical writer can help: Medical writers work with Sponsor team members to develop a timeline and review strategy that works with their schedule while also keeping the desired deadline in mind. A medical writer knows what is – and is not – doable for each task and can advise team members on creative ways to approach the timelines to increase team member engagement from the beginning of document preparation. Medical writers remain on the lookout for what can derail the timelines, and when team members start discussing needing additional time to review or bringing in new reviewers at a later stage in document development, the medical writer ensures the team understands the potential impact this can have on the document timelines and quality, so that they can make an educated decision on how to proceed.

How a Syner-G medical writer can help: Syner-G medical writers have developed a tool that shows all concurrent document activities on a single platform. If there are multiple overlapping documents in a submission, or other overlapping Sponsor team activities that need to be considered during document preparation, this tool helps visualize overlapping team activities, and avoid overlapping team activities, if possible. In addition, this tool makes it easy to see the impacts of delays…whether it be delays in delivery of data, delaying a review by a day, or having to move a meeting. Importantly, this tool also helps to proactively identify crunch times so team members can plan accordingly with their other responsibilities, and in doing so, remain engaged throughout document preparation so that the timelines can be met as planned – or possibly completed early!

Going back to the original question: how can we shorten the timeline? The “secrets to success” aren’t surprising and, in many ways, are obvious. What makes them challenging, though, is ensuring follow through. Make sure the team plans in advance, involve the medical writer early and often, and ensure the team members are consistently engaged and committed to completing their work on time. Medical writers are not miracle workers, but they do know the challenges to be on the lookout for and to avoid, and, if needed, to adapt to. These are just a few of the “secrets to success” that a medical writer contributes to the preparation of high-quality, on-time, cost-effective documents. If you’re interested in learning more of our “secrets to success,” please reach out!


Christina (Chrissy) Williams, PhD, RAC

Christina (Chrissy) Williams, PhD, RAC, is the Senior Director of Medical Writing Services and has over 20 years of regulatory medical writing and project management experience. Chrissy leads a team of medical writers and provides leadership and support for a variety of regulatory documents across a wide range of therapeutic areas in all phases of development (including IND clinical components, investigational brochures, protocols, clinical study reports, safety narratives, and high-level documents, such as integrated summaries of safety and efficacy, Module 2 clinical summaries and overviews, and FDA and Advisory Committee briefing documents).

Chrissy’s experience includes project management and medical writing for multiple marketing applications (NDAs/BLAs/MAAs), regulatory agency briefing documents, responses to regulatory agency queries, and regulatory designation requests (eg, orphan drug, rare pediatric disease, fast track, and breakthrough status). Chrissy’s experience synthesizing and interpreting scientific data, combined with a strong background in regulatory strategy, submission planning, and team leadership, enables her and her team of writers to provide a knowledgeable, flexible, and efficient approach to regulatory medical writing and project management.

Prior to joining Syner-G, Chrissy worked within medical writing at a mid-size pharmaceutical company for 10 years and as a regulatory scientist at a contract research organization for 3 years. Chrissy received her PhD in Biological Psychology (program since renamed to Behavioral and Integrative Neuroscience) at The University of North Carolina at Chapel Hill and was a Postdoctoral Research Associate at the Department of Pharmacology and Cancer Biology within the Duke University Medical Center.


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