Authoring regulatory documents: getting the best from your cross-functional teams

There’s no denying that authoring regulatory documents can be challenging! So, getting the best from your authoring team is a big step towards making document production an efficient and satisfying task.

Our Regulatory group at Bioscript has experience in guiding project teams to make the authoring of documents, such as clinical study reports, common technical document modules or submissions, as smooth as possible.

Challenges

Cross-functional teamwork often has difficulties. This is particularly true when team members are spread across multiple projects, and resources – be it personnel, time or budget – are limited. Both small and large teams have their own challenges, from scheduling, to allocation of responsibilities, to managing different work approaches.

This is why our workshop on Getting the best from your authoring teams begins with a focused section on document ownership. We work with attendees to recognise the value of defining roles and responsibilities of team members at the start of every project, including the use of RACI charts (Responsible, Accountable, Consulted, Informed) and document logs.

Making meetings matter

Working together efficiently as a team is a big step towards making the authoring process painless, but how do we ensure quality as well efficiency? One part of that is through strong organisation, including well-run meetings.

The inclusion of key meetings during document authoring has the dual benefit of ensuring everyone is on the same page and that all key team members have the information they need to work quickly and accurately.

Kick-off

A kick-off meeting is a perfect start to this process, after a well-run kick-off meeting, the whole team should understand

• how the document will be created and reviewed,
• which parts of the process they will be responsible for, and
• when they need to provide input.

Strategy

Another vital step for producing complex documents is a document strategy meeting, in which the team agree document purpose, content, context (where the document fits within the clinical development of the product), and key messages (keeping the vision for the product and its label in mind). These meetings give the team the opportunity to

• agree the strategy early,
• get agreement on direction from the key stakeholders, and
• capture key messages using techniques such as storyboards, message maps and document prototypes.

Effective document strategy meetings give the team ownership of the strategic vision of the document, helping to avoid additional unnecessary rounds of drafting and review.

Review

Another part of document production that can easily lead to inefficiencies is the review step. As part of our workshop training, we encourage team members to think about how they can each add value by giving strategic input, focused specifically on their area of technical expertise. We also provide advice and techniques on running data interpretation meetings and post-review comments resolution meetings; the time of your technical experts is valuable, and effective meetings let you make the most of it.

Smooth running

Of course, none of these steps are difficult, though they do require forward planning, strong organisational skills and early buy-in from the team. But, when followed, good processes work wonders: through clear accountabilities; good teamwork; appropriate time for key production steps; and respecting everyone’s expertise, we can help to make regulatory document production a smooth – and possibly even enjoyable! – process.

If you’d like to find out more about how Bioscript can help support your teams and projects, please contact us for a chat. info@bioscriptgroup.com