Decentralized Clinical Trial
Case Studies.

Designed, configured, and executed on our decentralized
clinical trial platform.

Case Study – Covid19 Therapeutic

Objectives:

Primary objectives were to

  1. Reduce duration and severity of symptoms, and
  2. Reduce hospitalizations

Highlights:

Inclusion criteria were recent diagnosis of Covid19, not hospitalized, over 50 years with one co-morbidity, and an O2>90%. Patient used their own devices. Patient burden was high, with a complex medicine schedule and twice daily ePRO entries.

Solution:

Curavit designed and deliverd a solution that included telehealth, e-consent, digital biomarker capture with devices, ePRO, and eCOA.

“We chose Curavit because of their exclusive focus on designing and executing virtual trials. We needed a company with Curavit’s expertise in this important new discipline of clinical research in order to make this trial possible.”

VP

Case Study – MODY Diabetes

Objectives:

Primary objectives were to

Determine if dulaglutide provides non-inferior glucose control compared with glimepiride in HNF1A or HNF4A diabetes. Glycemic outcomes will be assessed using a continuous glucose monitoring system. The primary study endpoint will be percentage of time spent in glycemic target range, 70-180 mg/dL, both inclusive, assessed by CGM, during a 10 day maintenance period at the end of each treatment period.

Highlights:

Inclusion critera is MODY diagnosis. Trial will span 34 weeks and 17 telehealth engagements with licensed medical professionals and Certified Diabetes Educators (CDE) in each state. PI and Medical Advisors reviewed studies confirming CGM could be effectively utilized in a full DCT setting.

Solution:

Curavit designed and deliverd a solution that included telehealth, e-consent, digital biomarker capture with devices, ePRO, and eCOA.

“There is great potential to improve the lives of MODY patients with accurate diagnosis and new forms of treatment. However, studying MODY patients is very challenging because of the small number of diagnosed patients and their distribution across the country. That is where Curavit comes in.”

MODY Researcher

Case Study – Novel study design to address previously observed study bias

Business Problem:

Remove observed study bias from a study that absolutely requires physical clinical sites for medical application and ongoing patient engagement.

Solution:

Curavit designed and delivered: patient awareness-building and self screening, EHR, vCOA, video data capture, and EDC.

“This trial will incorporate several novel study design elements that we believe will help address previously observed study bias”

CEO

We can't wait to work with you!

Find out more about what trials are – and aren’t – well suited for decentralized processes and technologies.  Curavit’s team can help you understand the challenges, and benefits.  Please contact us to learn more.