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CASE STUDY: PHASE 1 SAFETY ASSESSMENTS

Enhancing Phase 1 Clinical Trials with Point-of-Need Safety Assessments

THE CHALLENGE

Syneos Health, a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success, encountered an obstacle during a Phase 1 study. The study protocol required monitoring for potential ocular side effects, but the clinic lacked the specialized equipment and personnel to conduct comprehensive eye exams.

20/20 ONSITE SOLUTION

To address this specific need, 20/20 Onsite deployed the Mobile Clinical Suite (MCS) at the Syneos Health Miami Phase 1 Unit. This customized exam room, complete with advanced equipment and experienced staff, enabled comprehensive eye assessments without patients needing to travel off-site. The MCS facilitated convenient participation, maintained data integrity, and provided Syneos Health access to 20/20 Onsite's expertise in ophthalmological clinical trial protocols.

20/20 Onsite Clinical Trial Case Study

RESULTS

SUCCESSFUL TRIAL:
The study was completed successfully with more than 65 patients enrolled. Testing included:
  • Slit-lamp Examination
  • Retinal Imaging
  • Direct/indirect Ophthalmoscopy
  • Visual Field
  • Near Vision J Reading
COST-EFFECTIVENESS:

Syneos Health avoided significant investment in equipment and staffing while gaining access to specialized resources, and the study became more cost-effective for the sponsor as well.

ENHANCED PATIENT CARE:

Onsite eye assessments ensured patients received high-quality care within the familiar clinic environment while seamlessly integrating into the clinic workflow providing a smooth patient experience.

65+
Patients Successfully Enrolled
5
Testing Procedures

FINAL ASSESSMENT

Our MCS provided the missing link necessary to take on this Phase 1 clinical trial. The collaboration also opened new doors for Syneos Health, whose team previously had challenging experiences dealing with off-site eye assessments. 

Building on this success, Syneos Health and 20/20 Onsite are collaborating on additional Phase 1 trials, further showcasing the adaptability and impact of the MCS in diverse clinical research settings. Visit our website or contact us today to schedule a consultation and explore how our point-of-need solutions can support your clinical research!

"While working with 20/20 Onsite for previous and current studies, we have been able to provide ophthalmological services that were previously not feasible for our clinical units. Doing so has been very successful in providing safety and ophthalmological oversight of study participants – as required by good clinical practices and the sponsor protocol."

- Dr. David Wyatt, Vice-President and Global Medical Lead, Syneos Health

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