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CASE STUDY: INFECTIOUS LIVER DISEASE TREATMENT

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

THE CHALLENGE

Company X, a leading Contract Research Organization (CRO) renowned for its innovative approach to clinical trials, faced a challenge during a Phase 1 study for an infectious liver disease treatment. The study protocol required monitoring for potential ocular side effects, but their 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 Company X. 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 Company X access to 20/20 Onsite's expertise in ophthalmological clinical trial protocols.

mobile clinical suite

RESULTS

SUCCESSFUL TRIAL:
The study was completed successfully with 68 patients enrolled. Testing included:
  • Slit-lamp Examination
  • Retinal Imaging
  • Direct/indirect Ophthalmoscopy
  • Visual Field
  • Near Vision J Reading
COST-EFFECTIVENESS:

Company X avoided significant investment in equipment and staffing while gaining access to specialized resources.To acquire the proper equipment and personnel to conduct this study would have been a roughly $500,000 investment for the CRO.

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.

68
Patients Successfully Enrolled
5
Testing Procedures
$500K
CRO Resource Investment Savings

FINAL ASSESSMENT

Our MCS provided the missing link necessary to take on this Phase 1 clinical trial. The partnership also opened new doors for Company X, whose team previously had negative experiences dealing with off-site eye assessments. Thanks to the success of this trial, Company X and 20/20 Onsite are collaborating on additional Phase 1 clinical trials.

Building on this success, Company X and 20/20 Onsite are partnering 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."

-Company X Principal Investigator

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