Examining Strategies for Faster Clinical Study Report Timelines

How long does it take a medical writer to produce a high-quality clinical study report (CSR)? What can a medical writer do to help speed up this turnaround without sacrificing quality?

Biopharma companies are under increased pressure to reduce timelines, yet this acceleration cannot come at the expense of accuracy or regulatory compliance.

We spoke with PharPoint’s Associate Director of Medical Writing, Samia Khader, to discuss her thoughts on potential strategies for the faster delivery of a final CSR.

Evaluating the standard timeline for CSR delivery

CSR timelines can vary greatly depending on a range of factors which are not all under a medical writer’s control. That said, according the American Medical Writers Association, a common timeline for the delivery of a CSR is about 52-60 working days.

At PharPoint, our typical timeline from receipt of final Tables, Listings, and Figures (TLFs) to the delivery of a final CSR is 40 business days. This includes two rounds of review, with drafts reviewed by Sponsors within five business days.

What strategies might a medical writer use to accelerate CSR timelines responsibly?

Responsible acceleration of the CSR timeline requires deliberate process choices that can improve coordination and reduce inefficiencies while protecting quality and compliance of the final deliverable.

In the sections below, we outline several ways that a medical writer might help move a CSR forward, along with a verdict on each approach and the conditions where it makes sense (or does not).

Using multiple writers

There are circumstances where using multiple medical writers might provide meaningful acceleration, however, strategic planning and coordination is required for this to be effective.

For example, this might entail tasking one writer to work on the CSR body while another works on narratives and appendices, or contributes to peer review.

Having multiple writers work simultaneously on the CSR body, on the other hand, is not likely to produce significant efficiencies, as differing writing styles can raise consistency questions and comments, resulting in a longer review time.

Streamlining quality control (QC) processes

While we cannot cut corners when it comes to quality, we can plan QC activities strategically to deliver a high-quality deliverable sooner.

For example, the QC review and finalization of the CSR appendices and safety narratives can be completed before the QC review for the final CSR body review is initiated.

Supporting the peer review process

Providing clear oversight and instructions for the peer review process and ensuring that reviewers know what is expected of them is essential to have a comprehensive review of the document and have all review boxes checked.

(See: A Guide to Reviewing Regulatory Documents as an Subject Matter Expert)

Not recommended: Developing documents based on draft data

While we might assume that developing documents based on draft data could get your document final and publishing-ready sooner than if you wait for the final, clean, and approved data to develop your document, this is not always the case.

In fact, waiting for the final and approved data to develop a document is the most efficient and safest way to provide the highest quality document.

Looking for a medical writing team to support your CSR?

PharPoint Research is a contract research organization built for collaboration. Our medical writing team has ample experience supporting CSR delivery, and is experienced in a range of therapeutic area.

If you are currently evaluating medical writing vendors that can support both quality and quick turnaround, the PharPoint medical writing team is happy to discuss what CSR timelines are possible for your project.