Supporting Clinical Research in Digital Therapeutics
Digital Therapeutics (DTx) is a cutting-edge field that uses software, either alone or in combination with drugs or devices, to deliver evidence-based treatments to patients. These innovative therapies represent unique challenges when it comes to the design and execution of clinical trials that can support regulatory approvals. At VeraSci, our team has direct experience working with Digital Therapeutics, including working with sponsors to select and develop appropriate assessments and endpoints, address the particular challenges of digital placebos (sham treatments), and manage data collection challenges (in clinic, at home, and hybrid visit structures). We can help you design studies and select endpoints that will be accepted by regulators, payers, and patients.
Dependable Solutions for Global Clinical Trials
VeraSci is not just there in the beginning; we take care of your study objectives and data throughout the entire trial. As your partner, we leverage experience gained through hundreds of trials and ensure the highest quality data, all while anticipating any issues that can derail or delay your study before they arise.
We provide expert solutions in:
- Identifying Value Endpoints to demonstrate the pharmaeconomic value of novel therapies earlier in the development process
- Regulatory and protocol guidance
- Endpoint selection, trial design, and feasibility
- In-house language translation and cultural adaptation
- Global site selection and rater training
- Pathway eCOA solution with clinical, functional and cognitive scales
- Expert data review & on-demand reporting through VeraSci’s Signal Analytics
- Protocol consulting including inclusion and exclusion criteria selection
- Endpoint and efficacy validation
- Software translation and cultural adaptation