Patient-friendly Informed Consents


Development of Informed Consents

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Informed Consents written in language patients will understand

 

What Study Patients Need

It’s Basic!  Study patients need:

  • Informed Consents they can understand
  • To know “How to Take” the study drug
  • Why it is important to take the full dose
  • Easy-to-use packaging and reminder aides
  • Patient Diaries & Personal Progress Logs
  • Quick answers to questions
  • Two-way communication with study team and feedback on progress in trial

 

PATIENT ADHERENCE AND PATIENT RETENTION WILL INCREASE WHEN WE MEET THE NEEDS OF PATIENTS IN CLINICAL TRIALS

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Our Expertise in Clinical Trial Patient Education Is Unmatched

Let us put our over 30 years experience developing patient education programs for clinical trials to work for you! 

Our team has expertise in:
  • Developing the patient adherence strategy
  • Developing all the patient materials for patient recrutiment and clinical trials
  • Writing clinical information in an empathetic tone that patients can understand and relate to
  • Developing “patient-friendly” informed consent documents
  • Incorporating protocol into instructional study materials for clinical investigators
  • Developing Patient Package Inserts (PPIs) that can be tested prior to the NDA submission and receive speedy FDA approval
  • Notarized translations in 104 languages that can be used internationally

Our team of patient education experts have years of experience counseling patients and have worked with pharma medical, legal, regulatory and marketing teams and FDA for the past 20 years. All of our materials are designed with a focus on patient compliance with the goal that patients will be motivated to remain in the study and will take the study medications correctly.

“Make sure your study results are accurate.”

Click here for more information about Patient Package Inserts (PPI)Patient Compliance ProgramsDisease Management Programs, Personal Progress Logs. For confidential consultation to discuss any of your clinical trial needs give us a call today at (703) 734-0650.