"Our new Patient Consent form is now accepted as an industry best practice."
About the company
The company is a global pioneer in pharmaceuticals and diagnostics, committed to advancing personalized healthcare and improving patient outcomes.
The Challenge
The problem
Their patient consent form had become overly complex, filled with dense legal language that made it difficult for patients to understand. This slowed down clinical processes, creating a challenge for both patient comprehension and compliance.
What the form covered
The original document packed complex explanations about:
Patient participation
Personal data processing
Health data usage
The roles of third parties and the client
Privacy rights
Consent requirements
The Solution
Our approach
Information Mapping applied its research-based Methodology to:
Analyse the process
Capture the right content
Organize the content efficiently
Rebuild the template using its software FS Pro for Word
What changed in the form
The redesigned form introduced four key improvements:
Clear overview section: A dedicated overview stating the form's purpose, the stakeholders involved, what may or may not be shared with the client, and a table of contents, instead of continuous narrative text.
Explicit stakeholders: Clear identification of the patient, the service provider, and the client, with the responsibilities of each party.
Improved transparency: A table showing what can and cannot be shared with the client, with explained regulatory and safety-reporting exceptions.
Better navigation: Logical sections such as data collection, data transfer, privacy rights, and consent so patients find information easily.
What the client can and cannot access
The redesigned form makes data handling explicit:
General statistics: Can be shared with the client, for example, the number of enrolled patients.
Patient and health data: Cannot be shared with the client, except where required by regulations and safety-reporting obligations.
The new form
The new form is:
Clear and patient-friendly
Easy to navigate
Legally robust
Consistent across teams and regions
Beyond the document
The redesign also unlocked digital delivery. The same content could be:
Published as a website in two clicks using FS Pro
Shared through links and QR codes
Enhanced with digital signatures (planned DocuSign integration)
Made SCORM-compliant for e-learning and tracking
The Results
Adoption and recognition
The redesigned consent form was adopted across the organization and quickly gained recognition for its clarity and usability. The client described the new form as “an industry best practice.”
Measured improvements
Measured improvements included:
Faster patient comprehension
Reduced need for staff explanation
Higher satisfaction from clinical teams
Stronger alignment with patient-centric communication standards
