Making clinical research crystal clear

Plain language services

There has never been more demand for effective plain language communication.

Delivering breakthrough treatments involves many stakeholders – including researchers, regulators, grant approvers, healthcare professionals and patients. Everyone involved benefits from effective communication, however, the industry has only recently considered how best to communicate clinical research information more comprehensively to patients and the general public. This is recognised by global regulators and policymakers through regulatory requirements for plain language communication:

US FDA 21 CFR 50 Subpart B and Article 28 & 29 of European Union Clinical Trial Regulation (EU CTR) 536/2014 for the informed consent
EU CTR 536/2014 Article 37 and proposed changes to UK’s Clinical Trial Legislation for plain language summaries (layperson summaries)
Part 13, Chapter 1 of the UK’s Human Medicines Regulations (HMRs) and Article 54, Article 55 and Article 59 (Title V) of Directive 2001/83/EC for patient information leaflet

Translating technical terms and concepts used in clinical development into plain language requires significant expertise.

Our deep understanding of the complexity of public health communication

Our extensive experience in health literacy and numeracy principles

Social listening to understand how patients and public discuss health topics

Engaging with patient partners to better understand disease areas

Completed over 150 plain language communication materials

Delivered both content and graphic design support

Implemented plain language processes for study sponsors

Trained clinical study teams on plain language concepts and processes

Published articles on key developments in the plain language domain

Contributed to the development of industry standards

Plain language writing services, including but not limited to following documents

Informed consent documents (ICDs)

Trial consent element documents (TCEDs)

Plain language protocol synopses

Plain language summaries (PLSs) for clinical trial results

Plain language summaries of publications

Patient information leaflets

Patient recruitment material

Public health education material

Health literacy review of existing plain language material

Review of material by a patient representative panel (patient panel review) or public representatives (non-scientific panel review)

Facilitation of training for study teams on plain language concepts and processes

Graphic design support for plain language material (infographic, template designing, comic and video formats)

Advisory services, including understanding the implications of the regulations and developing process documents, e.g., SOPs, templates, glossaries, training material