Case Studies
The MOXIe Study
Therapeutic Area: Neurology/CNS | Rare
Disease Indication: Friedreich’s ataxia
Study Range: International
The Narrative:
This Phase 2/3 potentially registrational trial was conducted at a small number of sites in the U.S., EU, and Australia, with the recruitment materials translated into various languages. In a population/indication with 14 failed prior studies, the client’s study team was especially sensitive to the need to connect meaningfully with patients in order to explain the design of the study, maximize retention, and maximize subsequent enrollment in the Open Label Extension (OLE). This study resulted in drug approvals in the U.S. and EU, and the drug is marketed in the U.S. as Skyclarys.
Creative Scope
- Study branding
- Study logo
- Patient-facing website
- Patient newsletters
- Study newsletters
- Study visualization
- Executive-level reporting
- Board of Director
presentation elements - Regulatory inspection
support- Timelines
- Slide decks
- Enrollment data
The CARDINAL Study
Therapeutic Area: Nephrology | Rare Disease
Disease Indication: Alport Syndrome
Study Range: International
The Narrative:
This registrational study in children and adults was conducted globally, with sites in the U.S., EU and Australia. Patient engagement and retention were critical, given the study duration of two years, with key efficacy data accruing at the one-year and two-year periods. The creative program was robust and end-to-end, following the entire course of the study. It contributed significantly to the overall success of the recruitment – 48% of patients enrolled in Part 1 came through the study website and recruitment program. Additional creative support was provided throughout the inspection period, with a substantial set of visualization tools to aid cross-functional teams and inspectors during Clinical Investigator and Sponsor inspections by FDA, PMDA, and EMA.
Creative Scope
- Study branding
- Study logo
- Master study slide deck creation
- Investigator meeting support
- Website
- Study app for patients
- Study app for sites/CRAs
- Executive-level reporting
- Board of Director presentation elements
- Regulatory inspection support
The CYPRESS Study
Therapeutic Area: Neurology
Disease Indication: Diabetic Peripheral Neuropathic Pain (DPNP)
Study Range: U.S. Only
The Narrative:
After many years of recruiting in the rare disease space, this clinical-stage client moved into DPNP and needed our support to differentiate their study in a trial-saturated indication, for which there were already many approved products. The trial required quick enrollment and maximum retention. The client aimed to take an exceptional approach to site and patient engagement to secure more care and attention from sites. This is an actively recruiting program.
Creative Scope
- Study branding
- Study logo
- Master study slide deck creation
- Investigator meeting support
- Website
- Study app for patients
- Study app for sites/CRAs
- Executive-level reporting
- Board of Director presentation elements
- Branded patient and physician materials
UTI Study
Therapeutic Area: Urology
Disease Indication: Urinary Tract Infection (UTI)
Study Range: U.S. Only
The Narrative:
This client, a clinical site in the urgent care setting, was underperforming with recruitment of early onset UTI patients. A proposal was approved by the sponsor for a small advertising campaign to capture patients less than 48 hours after symptom onset. Digital ads and billboards were created as part of the integrated marketing campaign, which resulted in a significant number of patient leads, helping to enroll the study and build the patient population interested in trials at this site.
Creative Scope
- Study branding / design concepts
- Web landing page
- Digital ads
- Print/billboard ad campaign