Embedded and Exit Clinical Trial Interviews

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The power to enhance clinical research

High-quality patient experience data has become increasingly important for various stakeholders. Maybe you’re seeking to understand the impact of disease on patients’ lives or working to remove participation barriers and optimize future study protocols. Or perhaps you want to determine an early safety profile and risk-benefit assessment from your patients’ perspective, or better understand the patient experience with an investigational product not yet on the market. Embedded and exit interviews (EEI) can help provide the guidance you need to enhance your product’s success.

We’re here to help you mine those unique patient experience insights. With the largest dedicated EEI group in the industry and a proven track record, you can count on us to find the answers you seek. We help to make a meaningful difference in implementing your product and improving patients’ lives.

See how EEI in-trial insights help you level up your drug development plan

A proven track record of expertise and success

Dedicated EEI experts

We have the largest dedicated EEI group in the industry. The team comprises 40+ scientific experts with experience addressing challenging logistics while conducting EEI in-trial studies.

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Extensive EEI expertise

Our patient-centered research and EEI teams have industry-leading expertise in conducting these interviews and illuminating the patient voice throughout the drug development life cycle.

A proven track record

We have an established track record of conducting high-quality EEI projects on time and on budget. Our team has worked with 25 countries across the globe, 30+ therapeutic areas, and 45 studies.

Deep trial insight at any time, in any phase of your trial

From early Phase II through post-marketing, EEIs can provide expanded insights that will inform the path forward for your product. With the supplemental data gleaned from these interviews, we can optimize clinical trial design, enhance interpretation of clinical trial findings, improve your product’s value for payers and ensure patients’ unmet needs are being addressed. When you partner with us, you have a team of highly skilled strategic planners, scientists and analysts  experienced in embedding qualitative interviews with patients, caregivers or trialists into the clinical trial process.

Leveraging EEI throughout your product’s life cycle

EARLY PHASES (BY PHASE I AND PHASE II)
Understanding the Disease

Objectives

  • Understand patients’ experience
  • Develop a conceptual model
  • Identify concepts/ outcomes of importance to patients
  • Inform endpoint strategy
  • Better understanding of treatment side effects
Particularly useful in rare disease
Characterization of treatment benefit and safety profile

Objectives

  • Understand patient experience with new treatment
  • Generate a hypothesis on treatment benefit
  • Identify what constitutes meaningful effect/change
  • Confirm concepts/outcomes of importance
  • Cognitively assess new PROs
  • Maximize signal detection and support internal decision-making
  • Build a strong differentiation strategy
  • Confirm Phase III measurement strategy
PHASE III
Interpretation of trial outcomes

Objectives

  • Help interpret a clinically meaningful change in clinical outcome score
  • Support value messages based on direct input from patients
Support FDA submission, including generating evidence for the ”patient experience” section of the label
PHASE IV, POST-MARKETING
Product safety and market surveillance

Objectives

  • Optimize product implementation into clinical practice
  • Detect long-term effects of treatment
  • Explore the long-term experience of living with new treatment
  • Explore adherence and compliance with treatment

The bespoke solutions you need to confidently navigate the complexities of EEI

There are great benefits that come with high-quality, qualitative data in trial participant interviews, but there are also added challenges. Our expert team creates customized EEI solutions to meet your needs and proactively addresses obstacles associated with trial conduct, interview conduct and quality control. Leveraging our proven process and strategies, we ensure the successful implementation of interview studies within the clinical trial program in an ethical and confidential manner — helping you get the most out of capturing the patient voice.

How we put EEI within reach

  • Leveraging logistics already in place in the clinical trials (e.g., site contracting, ethics process, patient recruitment and tracking)
  • Develop strategies that remove any extra burden inherent on sites and patients participating in interviews
  • Create a tailored approach that details patient confidentiality will be maintained
  • Define the appropriate interview window to study design and conduct interviews after the treatment and administration of study measures, not before
  • Develop methods to supplement AE reporting that are not duplicative of the clinical trial
  • Support culturally diverse patients with well-trained bilingual and culturally versed interviewers while assuring consistency across countries
  • Conduct bespoke training and standard assessments of interviewer performance
  • Manage quality control and provide regular feedback on interviewer performance on an individual basis
  • Apply advanced methodologies to enhance clinical trial findings (e.g., mixed methods research, longitudinal qualitative research)

Ready to take patient-centric research
to the next level?

See how our EEI team and services can help.