Trial Results Summaries
We are the leading global provider of plain language clinical trial results summaries. Let us show you why.
Our award-winning program will help your organization provide plain language trial results summaries efficiently, with exceptional care and quality. CISCRP can assist your organization in preparing for and complying with European Union Clinical Trials Regulation (EU CTR) trial results requirements and the expected FDA requirements to follow.
The Problem
It is a challenge for sponsors to create sufficient plain language summaries (PLS) of clinical trial results.
Every completed trial should be accompanied by a PLS that follows health literacy best practices, is unbiased and transparent. Not only do clinical trial participants deserve and expect an easy-to-understand summary of the results from their trial, but it is also a requirement with specific content guidelines according to the EU CTR.
61%
of participants did not receive any reports on the results of their trial
CISCRP's Solution
Many sponsors have turned to CISCRP for assistance in creating plain language summaries for every clinical trial in an efficient and scalable way. CISCRP brings nearly 15 years of expertise and experience preparing thousands of plain language trial results summaries for each of our engagements.
Our large and growing health communications team is made up of exceptional project managers, medical writers, editors, and graphic designers trained in health literacy best practices who can deliver high-quality summaries while meeting sponsor’s demanding deadlines
In addition, our team is intimately familiar with the clinical research process and gathers input on our summaries from a review panel comprised of a diverse community of patients, patient advocates, the public, and health care professionals.
CISCRP’s internationally recognized solution produces the highest quality content that is well-organized, easy to navigate, visually appealing and compliant with global regulatory requirements. And CISCRP’s trial results summaries include all required elements for layperson summaries identified in Annex V of the 2014 EU Clinical Trials Regulation, which is necessary for a summary to be published in the EU database.
Program Setup
Let CISCRP help you set up and implement your organization’s trial results summary program.
- Highly specialized, extensive expertise and experience to help you build, launch and grow your organization’s commitment to providing plain language trial results summaries to your study volunteers
- Operationalize our insights from thousands of projects with sponsors across all therapeutic areas, phases, and study types
- Knowledge and experience developing all the necessary templates, operating procedures, guidelines, trainings, and tools
