Decentralised Clinical Trial regulatory workbooks across 24+ jurisdictions

Background

Decentralised Clinical Trials (DCTs), clinical trials that use digital tools, remote data capture and at-home or near-home patient touchpoints to reduce the burden of trial participation — sit at the leading edge of clinical research. They also sit at the leading edge of regulatory complexity: each jurisdiction has its own view on what is permitted, what conditions apply, and what authorisation pathway a sponsor must follow before running a DCT.

Our client, a regulatory intelligence platform serving the global life sciences sector, needed an authoritative jurisdiction-by-jurisdiction reference covering the regulatory pathway to obtain authorisation for DCTs in each of the markets their customers operate in. The reference had to be deep enough for a sponsor's regulatory affairs team to use as a working starting point, and accurate enough to remain credible as the underlying regulation continued to develop.

The LS Law Approach

Authored DCT workbooks in three tranches — and kept them current. We delivered the workbooks in successive tranches, each covering a defined set of jurisdictions to a fixed timeline. Each workbook used a consistent structure provided by the client — so a regulatory affairs team could move from one country to another without having to relearn how to read it — but the content within each was researched and authored from scratch against the relevant national framework.

Workbook authoring. Working through each jurisdiction's regulatory framework and authoring the workbook against the client's structure — including the local authorisation pathway, the competent authority, the relevant submission requirements, and the local-law nuances that don't appear in the headline framework.

Tranched delivery. Phased delivery to a fixed timetable — so the client could roll the workbooks into their platform progressively rather than waiting for a complete set. Each tranche covered a clinically meaningful regional cluster (EU markets, the Americas, APAC, Middle East).

Ongoing update service. A continuous regulatory update service running alongside the authoring work — monitoring each jurisdiction's framework for material developments and refreshing the workbooks so the reference stays current rather than going stale six months after delivery.

Four regions. Twenty-four-plus jurisdictions. The workbooks cover the markets where the client's customers most commonly run DCT programmes, and coverage continues to expand as the client's needs grow. Europe: EMA (EU-level), Germany, France, Italy, Spain, Belgium, Poland, Sweden, Switzerland, UK. Americas: USA, Canada, Mexico, Brazil, Argentina. Asia-

Pacific: Japan, China, South Korea, India, Malaysia, Thailand, Philippines, Indonesia. Middle East: Dubai (UAE), Abu Dhabi (UAE).

The Outcome

A working reference that holds up under use. The workbooks are now in use as the working reference for the client's customers — sponsor-side regulatory affairs and clinical operations teams who need a credible starting point for planning a DCT in any of the covered markets. The ongoing update service ensures the reference stays current as each jurisdiction's framework develops.

From scratch to a global DCT regulatory reference, in three tranches. A comprehensive, jurisdiction-by-jurisdiction reference for DCT authorisation across 24+ markets — sufficiently deep to be a working starting point for sponsor regulatory affairs teams, and continuously maintained so it doesn't go stale.

24+ jurisdictions covered. 4 regions. 3 delivery tranches. Ongoing regulatory update service.