Lay Summaries Writing Services for Clinical Trials

Ensure regulatory adherence, promote transparency, and address the diverse needs of a global audience

Drug developers are required to communicate their clinical trial results to the trial participants. The complexity of scientific data often creates a barrier for patients and the public to grasp essential information.

This ease of understanding trial results and recruitment information for patients and the public, and the transparency it creates, is a regulatory requirement.

Lay summaries (also known as plain language summaries, layperson summaries, lay language summaries, simple summaries, and trial results summaries) intended to make the results of the clinical studies understandable and reachable to patients, caregivers, and a general audience. These summaries are a vital tool in bridging the communication gap by translating intricate data into accessible language. In essence, life science companies turn to lay summaries to overcome these challenges, offering clarity and understanding to a broad and varied audience.

Expertise in Lay Summaries and Regulatory Compliance

Writing Plain Language Study Results Summaries for submission to Clinical Trials Information System (CTIS) according to European Union (EU) Clinical Trial Regulation 536/2014.

Plain Language Protocol Synopsis (PLPS) of Clinical Trials for submission to CTIS according to European Union (EU) Clinical Trial Regulation 536/2014.

Plain Language Summary for International Standard Randomised Controlled Trial Number (ISRCTN) registry per Medicines and Healthcare products Regulatory Agency (MHRA).

Plain Language Summary of Publications (PLS-P), a standalone summary of an original scientific (published or accepted) article.

Plain language summaries for devices.

Translation of summaries into local languages for submission to participants at different sites in different countries.

Non-technical person review i.e., inputs from a panel consisting of members without medical or scientific background.

Standard Operating Procedures (SOP) development.

Consulting related to Lay Summaries.

Translation into local languages.

Lay summary template development meeting regulatory requirements.

Distribution of lay summaries.

Easy-to-understand language and suitable graphics to make the summary reader-friendly.

Writing and review of other participant facing materials such as Informed consent documents (ICD) and Informed Consent Forms (ICFs).

Streamline Compliance and Maximise the Reach of Your Clinical Results

Trust Quanticate to be your partner in navigating the complexities of lay summaries and regulatory compliance.

Contact us today to elevate the impact of your clinical trial results on the broader public.

Team Leaders

Karen Ooms

Joint Chief Operating Officer

Karen Ooms is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a Senior Statistician at Unilever.

Lay Summaries Writing Services for Clinical Trials

Ensure regulatory adherence, promote transparency, and address the diverse needs of a global audience

Expertise in Lay Summaries and Regulatory Compliance

Streamline Compliance and Maximise the Reach of Your Clinical Results

Team Leaders

Request a Consultation

We are here to help you prove your efficacy and safety in your next project.

Lay Summaries Writing Services for Clinical Trials

Ensure regulatory adherence, promote transparency, and address the diverse needs of a global audience

Expertise in Lay Summaries and Regulatory Compliance

Streamline Compliance and Maximise the Reach of Your Clinical Results

Team Leaders

Medical Writing resources to support you in the creation of well written regulatory documents

[Webinar] Regulatory Submission Review

Bayesian Study Design: Using Interim Analyses to Improve Efficiency in Drug Development

Integrated Summaries (ISS/ISE)

Request a Consultation

We are here to help you prove your efficacy and safety in your next project.