Therapeutic Area Expertise Guides eCOA, IRT, and eConsent Implementation.

From oncology and infectious disease to cardiovascular, hematology, and more, YPrime has the in-house expertise to support multiple therapeutic areas, working with all stakeholders to streamline operations and deliver high­ quality data throughout the clinical trial process.

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A Deep Understanding of Clinical Trial Technology.

YPrime guides clinical operation leaders with best practices to implement clinical trial technologies-tailoring project design based on insights and experience. With a deep understanding of IRT, eCOA, and eConsent, YPrime experts support:

  • Icon 1 Software design optimization based on protocol evaluation­ working closely with sponsors to ensure technology seamlessly supports study and patient needs, improving compliance and patient engagement
  • Icon 2 Advice on drug supply management- enables improved forecasting to maximize drug availability, driving a smooth patient and site experience
  • Icon 3 Collaboration with industry experts- to ensure our eCOA, eConsent, and IRT solutions meet the specific needs and requirements of each therapeutic area
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Supporting Complexities Across Therapeutic Areas.

YPrime delivers expertise across a wide range of therapeutic areas, supporting participants and caregivers alike. With each new release, our technology continues to drive innovation that improves user experience and data quality. Recent eCOA updates include:

Our pre-validated eCOA platform ready for immediate deployment
Pre-configured to handle complex study changes with ease
Strategic guidance from our therapeutic area specialists ensured seamless implementation
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A Pediatric Epilepsy Case Study
An Oncology Case Study
A Global MDD Case Study

YPrime in Action—
A Pediatric Epilepsy Study.

A biotech company came to YPrime with a Phase 1 / 2 genetic therapy pediatric epilepsy study. They had an existing eCOA vendor but needed guidance from an industry leader with global regulatory expertise. The sponsor needed support navigating:

We delivered:

Global regulations with genetic therapies
Challenges involving 10-12 complex assessments
Significant amounts of study reference data

YPrime’s expertise in navigating global regulations, coupled with our advanced eCOA, enabled the sponsor to successfully launch their study without delays.

Access The Case Study Here

YPrime in Action—
A Pediatric Epilepsy Study.

A biotech company came to YPrime with a Phase 1 / 2 genetic therapy pediatric epilepsy study. They had an existing eCOA vendor but needed guidance from an industry leader with global regulatory expertise. The sponsor needed support navigating:

We delivered:

Global regulations with genetic therapies
Challenges involving 10-12 complex assessments
Significant amounts of study reference data

YPrime’s expertise in navigating global regulations, coupled with our advanced eCOA, enabled the sponsor to successfully launch their study without delays.

Access The Case Study Here

YPrime in Action —
An Oncology Study.

In a recent clinical trial, YPrime’s IRT streamlined a complex oncology trial design, meeting the demands of an adaptive Phase 1 protocol with flexibility and precision.

YPrime delivered:

Configurable randomization and supply parameters — Empowering the sponsor to easily manage randomization and supply requirements, with flexibility to configure each cohort’s unique needs
Swift cohort and dose adjustments — Real-time dosing adjustments at the subject or cohort level, supporting adaptive design essential for oncology trials
Fast implementation and scalability — Phase 1 study setup implemented in under four weeks, with accelerated data collection that enabled swift progression to subsequent development phases

Access The Case Study Here

YPrime in Action —
An Oncology Study.

In a recent clinical trial, YPrime’s IRT streamlined a complex oncology trial design, meeting the demands of an adaptive Phase 1 protocol with flexibility and precision.

YPrime delivered:

Configurable randomization and supply parameters — Empowering the sponsor to easily manage randomization and supply requirements, with flexibility to configure each cohort’s unique needs
Swift cohort and dose adjustments — Real-time dosing adjustments at the subject or cohort level, supporting adaptive design essential for oncology trials
Fast implementation and scalability — Phase 1 study setup implemented in under four weeks, with accelerated data collection that enabled swift progression to subsequent development phases

Access The Case Study Here

YPrime in Action—
A Global MDD Case Study.

A top 10 clinical trial sponsor was looking for an eCOA expert to support a global, three-study program in major depressive disorder (MDD). This large program required an eCOA leader to support nearly 300 sites across 40+ countries.

We delivered:

Successful and timely implementation of the visit schedule on handheld devices—enhancing data quality while prioritizing the patient experience
A live eCOA system four weeks ahead of the first patient in (FPI), accelerating the clinical trial process and staying within budget
Devices on site three weeks prior to the FPI, allowing for comprehensive testing and ensuring all was in place well ahead of schedule

Access The Case Study Here

YPrime in Action—
A Global MDD Case Study.

A top 10 clinical trial sponsor was looking for an eCOA expert to support a global, three-study program in major depressive disorder (MDD). This large program required an eCOA leader to support nearly 300 sites across 40+ countries.

We delivered:

Successful and timely implementation of the visit schedule on handheld devices—enhancing data quality while prioritizing the patient experience
A live eCOA system four weeks ahead of the first patient in (FPI), accelerating the clinical trial process and staying within budget
Devices on site three weeks prior to the FPI, allowing for comprehensive testing and ensuring all was in place well ahead of schedule

Access The Case Study Here
A Pediatric Epilepsy Case Study
An Oncology Case Study
A Global MDD Case Study

YPrime in Action-
A Pediatric Epilepsy Study.

A biotech company came to YPrime with a Phase 1 / 2 genetic therapy pediatric epilepsy study. They had an existing eCOA vendor but needed guidance from an industry leader with global regulatory expertise. The sponsor needed support navigating:

We delivered:

Global regulations with genetic therapies
Challenges involving 10-12 complex assessments
Significant amounts of study reference data

YPrime’s expertise in navigating global regulations, coupled with our advanced eCOA, enabled the sponsor to successfully launch their study without delays.

Access The Case Study Here

YPrime in Action-
A Pediatric Epilepsy Study.

In a recent clinical trial, YPrime’s IRT streamlined a complex oncology trial design, meeting the demands of an adaptive Phase 1 protocol with flexibility and precision.

YPrime delivered:

We delivered:

Configurable randomization and supply parameters — Empowering the sponsor to easily manage randomization and supply requirements, with flexibility to configure each cohort’s unique needs
Swift cohort and dose adjustments — Real-time dosing adjustments at the subject or cohort level, supporting adaptive design essential for oncology trials
Fast implementation and scalability — Phase 1 study setup implemented in under four weeks, with accelerated data collection that enabled swift progression to subsequent development phases

Access The Case Study Here

YPrime in Action—
A Global MDD Case Study.

A top 10 clinical trial sponsor was looking for an eCOA expert to support a global, three-study program in major depressive disorder (MDD). This large program required an eCOA leader to support nearly 300 sites across 40+ countries.

YPrime delivered:

Successful and timely implementation of the visit schedule on handheld devices—enhancing data quality while prioritizing the patient experience
A live eCOA system four weeks ahead of the first patient in (FPI), accelerating the clinical trial process and staying within budget
Devices on site three weeks prior to the FPI, allowing for comprehensive testing and ensuring all was in place well ahead of schedule

Access The Case Study Here
It is surprising that paper is still the #1 competitor to eCOA. When patient experience and data quality are considered, eCOA is the best option for clinical trials. When cost is considered, the ROI of eCOA is far superior to paper.
Donna M. Mongiello, RN, BSN – Senior Vice President, eCOA Strategy, YPrime

Let’s Solve for Certainty in
Clinical Research—Together!

When we work together, you know that your clinical trial data is always compliant. Our eCOA, IRT, and eConsent platform helps you deliver the
clinical trial outcomes you need. Let’s get started! 

Explore Insights From Our Experts.

Gain valuable perspectives on clinical trial design, high-quality data capture, operational efficiencies, and, ultimately,
solving for certainty in clinical research. 

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