Digital Therapeutics

Digital Therapeutics requires a new kind of CRO

Digital Therapeutics development challenges traditional processes and demands CRO experience and adaptability in order to navigate regulation, help design studies efficiently, and capture quality data to accelerate development.

Biorasi is the only forward-thinking CRO that already has the foundation and methodology in place for delivering successful Digital Therapeutics trials

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Fully Technology Enabled

Talosᵀᴹ is our state of the art clinical research management platform that powers our clinical trials and ensures quality data capture and real time analysis to ensure the methodology of your SaMD will meet applicable regulatory data requirements

Accelerated Recruitment

Unleash the potential of partnerships with advocacy groups and national registries, and our global site network to quickly access difficult to target patient populations and meet your recruitment goals

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Regulatory Expertise

Avoid delays and uncertainty by partnering with a CRO that knows how to navigate the novel regulatory environment for DTx and Software as aMedical Device (SaMD), both in the US and around the world

Biorasi is a proven pioneering partner in Digital Therapeutics research that can make groundbreaking therapies a reality. Join us in our next webinar lead by our experts:

WEBINAR

Developing a Digital Therapeutics Trial

As digital therapeutics are integrated into every aspect of the healthcare landscape, patients, payers, and providers are seeing an increasingly complex set of software-driven therapy options reaching the market. This rapidly expanding field has enormous potential but faces challenges at every stage, from design to patient perception. Focusing on the clinical trial stage, how does the trial of a digital therapeutic compare to that of a pharmaceutical? What are the specific challenges of running a digital therapeutics clinical trial, and how can sponsors adapt their approach for the highest chance of success?

Attendees will learn the following:

  • Similarities and differences of running a digital therapeutics clinical trial compared to a pharmaceutical trial?
  • How sponsors and CROs collaborate differently: site equipment, data capture, storage and analytics, approval pathways
  • How sponsors adapt their approach to overcome those challenges?

Our subject matter experts are:

Jimmy El Hokayem, PhD
Jimmy El Hokayem, PhDHead, Neurology and Regenerative Medicine Center of Excellence
Wayne Bowden
Wayne BowdenVP Program Development

Join Us

Tuesday, Sep 17, 2019

2:00 PM – 3:00 PM EDT

Register Now

Therapeutic Area Mix

Digital Therapeutics trials entail a plethora of innovative logistics to efficiently treat, manage or even prevent a wide spectrum of physical, mental and behavioral conditions.

  • Patient-centric approach to trial execution that includes training and education

  • State of the art technology enabled clinical research management platform

  • Cutting-edge data sciences team that is a crucial part for navigating trial progress
  • Experienced medical and scientific affairs team creating protocol design and clinical development plan
  • Seasoned regulatory staff providing valuable support for software, device and device-drug based therapeutics

Biorasi is currently working
on multiple Digital Therapeutics
clinical trials in these areas:

Neurology 43%
Oncology 22%
Rare Disease 22%
Obesity 10%
Others 3%

We’re ready to answer your questions on digital therapeutics

Schedule a Call

Disrupting Industry Standards

Biorasi optimizes every step of clinical trials, cutting industry timelines by up to 70%

Protocol Finalized to First SSV

Biorasi

Industry Standard

5 days
14 days

SSV to SIV

Biorasi

Industry Standard

28 days
90 days

SIV to First Subject In

Biorasi

Industry Standard

5 days
21 days

Last Subject Out to Database Lock

Biorasi

Industry Standard

15 days
45 days

Database Lock to Top Line Results

Biorasi

Industry Standard

3 days
14 days

TOTAL TIME SAVINGS 70% SAVINGS

Biorasi

Industry Standard

54 days
184 days

Disrupting Industry Standards

Biorasi optimizes every step of clinical trials, cutting industry timelines by up to 70%

Protocol Finalized to First SSV

Biorasi

Industry Standard

5 days
14 days

SSV to SIV

Biorasi

Industry Standard

28 days
90 days

SIV to First Subject In

Biorasi

Industry Standard

5 days
21 days

Last Subject Out to Database Lock

Biorasi

Industry Standard

15 days
45 days

Database Lock to Top Line Results

Biorasi

Industry Standard

3 days
14 days

TOTAL TIME SAVINGS 70% SAVINGS

Biorasi

Industry Standard

54 days
184 days