RFP

EXPERIENCE YOU CAN TRUST

Scientific Consulting

EXPERIENCE YOU CAN TRUST

Scientific Consulting

Put Calyx's experience to work for you.

Your compound deserves every chance to succeed. But when your endpoints require medical imaging, risks are increased. Does your team have the experience needed to meet the scrutiny of regulatory review?

Rely on Calyx Scientific Consulting to drive the success of your development program. With experience from 2,600+ imaging studies and having supported over 250 new drug approvals – including half of the recently approved oncology treatments designated as Breakthrough Therapies – Calyx can help you design and implement an imaging strategy that gets your compound across the finish line. Faster.

MEET OUR EXPERTS

Meet the Experts

Extend the deep and diverse experience of Calyx’s highly tenured scientific experts to your own clinical development team.

Contact us today for a complimentary 1-hour consulting session with our experts.

SCHEDULE TODAY

Meet the Medical Writing Experts

Contact us today for a complimentary 1-hour consulting session with our experts.

Optimize your imaging ROI.

Whether you’re in early phase development looking to partner or planning to take your compound through to regulatory approval, Calyx Scientific Consulting offers valuable services to optimize your medical imaging investment. The benefits of working with Calyx Scientific Consulting include:

Enabling the success of early phase clinical trials and laying a foundation for later phase strategies

Use our time-tested design methodology to build assurance and confidence among your investors.
- Select the optimal imaging biomarker arrangement to best demonstrate safety and efficacy at each trial phase
- Choose the ideal image acquisition strategy to best support your biomarker requirements
- Find, vet, and select the right vendors based on your unique requirements
- Learn from our team of scientific advisors what to look for as you select the ideal investigators and sites
- Gain better data to make the critical decision whether to advance to the next phase of your clinical trial
- Enable better target patient populations with a better trial design
- Accelerate your success: Improve your chances of achieving Breakthrough Therapy designation and help alleviate the suffering of more people, faster

Identifying risk and efficacy signals at the earliest possible moment

Tune the data science to improve outcomes and reduce the risk of delaying failure.
- Calculate optimal trial size and duration with greater accuracy using better biomarker performance assumptions
- Properly monitor the performance of the imaging biomarker to help ensure the study is generating the expected results
- Avoid costly mistakes by consulting with our imaging biomarker experts when designing your study protocols

Streamlining Regulatory Approvals

Don’t get blindsided by unanticipated regulatory requirements, timelines, and scrutiny.
- Reduce delays by anticipating challenges surrounding regulatory filings, inspections, and agency meetings
- Ensure you have the evidence to support the decisions you make in order to support regulatory filings, inspections, and agency meetings.
- Make sure you have the data needed for regulatory submission by defining the right strategy around blinded central and investigator review