Compliance and Transparency

Experts at the forefront of change to meet and exceed a shifting global regulatory environment.

Expertly-crafted solutions allow sponsors flexible implementation with rigid compliance.

Lay Summaries of Clinical Trial Results For Laypersons

As an industry leader in the creation of lay summaries, MMS develops programs for sponsors to meet and exceed future regulations. With a team of dedicated lay summary writers, graphic designers, lay reviewers, and project managers, the specialists at MMS are singularly focused on ensuring the success of every lay summary created.

Lay summaries increase public interest and trust in the clinical research process, but implementing a new deliverable, understanding industry best practices, and distributing these documents can be daunting without the right partner. MMS experts ensure that all lay summaries present accurate, non-promotional information that are meaningful and understandable to the average person.

Lay summary support includes:

  • Writing plain language summaries
  • Improving existing lay summaries
  • Lay review (review and input by a panel without medical or scientific training)
  • Template development and aligned with regulation-required elements
  • SOP development and consulting
  • Graphic design and layout
  • Translation into local languages
  • Supporting lay summary distribution
  • Review of other patient-facing materials, including Informed Consent Forms (ICFs)

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