Situation
- A pharmaceutical sponsor conducted a global Phase III chronic weight management study.
- This study took place at more than 100 sites and at participants’ homes in North America, Europe and APAC.
- The sponsor required accelerated setup to meet study timelines as well as an eDiary to record blood glucose levels and ePRO responses.
The challenge
Fast set-up times ensure sponsors can more easily meet IRB submission and first patient in (FPI) dates. However, a number of factors can put pressure on timelines, such as:
- Complicated study documentation requiring detailed review and sign-off.
- Delayed involvement of study team members post kick-off rather than early during the proposal stage.
- Bespoke builds of assessments.
- Questionnaire licensing and device provisioning on a global scale.
Partnering with the right eCOA provider who has the tools, technology and expertise to get trials up and running quickly is key.
Visit our type 2 diabetes and obesity therapeutic areas page to learn more about how we can help solve your study challenges.
Clario’s rapid setup
Simplified eCOA Charter
- Clario has a new simplified 25-page Customer Charter.
Early involvement of study team
- Clario Solution Design and Programming teams were involved upfront.
Standardized assessments
- Pre-built, pre-validated assessments from Clario’s library were used.
Our solution
We were engaged to provide remote and at-site eCOA data collection for the study.
The solution involved:
- Provisioned at-site tablets with quality of life and suicide ideation and behavior (C-SSRS) assessments.
- Provisioned at-home handhelds with daily dosing diaries.
- U.S. English versions of assessments for translation.
- Assessment licensing and device provisioning for each country by our global in-house logistics team.
We leveraged prior experience with working with the sponsor. This included re-using and re-engineering documentation and a library of sponsor-specific assessments, as well as integrating previous software builds and reporting.
Success factors
We completed the study setup in 10 weeks from kick-off.
Our approach involved:
Simplified eCOA Charter
- Simplified and shorter documentation with accessible and easy-to-understand language.
- Reduction in specification document from 125 pages to 25 pages.
Early involvement of study team
- Pre-assigned involvement of operational resources during the proposal review stage including our Clario Solution Design and Programming teams.
- Quick and early build-out of the study documentation ensured.
Standardized assessments
- Pre-built and pre-validated assessments from our standardized library (representing half of those used).
- Minimal modifications to assessments prior to release, accelerating setup.
Impact
Timelines hit
- Our accelerated approach ensured the sponsor’s 10-week setup timeline was met.
Accelerated enrollment
- Our solution expedited the arrival of devices on site, which meant sites could get ready quicker.
- As a result, participant enrollment could start earlier.
Accelerate your patient enrollment and hit your study timelines
Visit our type 2 diabetes and obesity therapeutic areas page to learn more about how we can help solve your study challenges.