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Case Study

ADHD Study

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm the safety and efficacy of its ADHD therapeutic on a more real-world population. Phases I-III included narrow inclusion and exclusion criteria.

CNS
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Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.
Case Study

ADHD Study

CNS
Download the PDF

Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.
Case Study

ADHD Study

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm the safety and efficacy of its ADHD therapeutic on a more real-world population. Phases I-III included narrow inclusion and exclusion criteria.

CNS
Download the PDF

Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.
Case Study

ADHD Study

CNS
Download the PDF

Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.
Case Study

ADHD Study

CNS
Download the PDF

Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.
Case Study

ADHD Study

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm the safety and efficacy of its ADHD therapeutic on a more real-world population. Phases I-III included narrow inclusion and exclusion criteria.

Download the PDF
CNS

Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.
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Case Study

ADHD Study

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm the safety and efficacy of its ADHD therapeutic on a more real-world population. Phases I-III included narrow inclusion and exclusion criteria.

CNS
Download the PDF

Challenge

A biopharmaceutical company is seeking a Phase IV clinical trial to confirm safety and efficacy of its ADHD therapeutic on a more real-world population, since phases I-III included more narrow inclusion/exclusion criteria.

‍

Solution

  • Cohort includes ADHD-diagnosed adults with co-morbid mood symptoms and those who are taking concurrent medications—a population more representative of the real world.
  • Both clinicians and patients report outcomes remotely, enabling data capture to occur in more real-world settings.
  • A digital device is used to capture blood pressure readings and pulse. (Previous studies showed an increase in blood pressure and heart rate while on the therapeutic.)

‍

Study Design

  • Fully Virtual
  • ePRO
  • Sensors and Wearables
  • Remote Screening
  • Telehealth
  • eClinRo
  • Oracle Integration
  • Shipping Direct to Patients

‍

The study is ongoing at this time.

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