Efficiently develop a clear and concise plain language protocol synopsis for every clinical trial, to help all stakeholders quickly understand why and how the research is being done—from patients and the public to study site staff, ethics committees, and regulatory reviewers.
Patients and the public often do not find clear and concise information about specific clinical trials when they search for research that is relevant to them. This represents a missed opportunity to appropriately engage and inform patients from the start of their clinical trial experience. This critical issue, along with emerging requirements and recommendations relevant to the European Union’s Clinical Trial Regulation (EU) No 536/2014 (EU CTR), are compelling researchers to develop a standardized and efficient approach to providing a plain language protocol synopsis for each of their clinical trials.
CISCRP will work from your clinical study protocol to create an engaging plain language summary of the protocol synopsis. Following CISCRP’s widely recognized Health Communication processes and practices, our medical writers and plain language editors will efficiently collaborate with your team to create an engaging protocol synopsis. For a protocol synopsis submitted under the EU CTR as part of your initial application for a clinical trial, we will align with current recommendations and guidance, including the nine recommended elements and two-page limit.
Skilled team of medical writers and plain language editors
Two-page limit that enhances engagement
Engage patients from the start of their clinical trial experience