Clinical Trial Support

Clinical Research & Scientific Consulting

“An investment in knowledge pays the best interest.”
- Benjamin Franklin

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?

Consult with one of our experts.

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 the experts.

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

CALYX-20-Headshots-StephenBravo-FINAL

Stephen M. Bravo, MD

Chief Medical Officer, Calyx

An acknowledged expert in Neuroradiology, Musculoskeletal Radiology, and Interventional Radiology, Stephen brings more than 30 years of broad experience to Calyx. His expertise stems from having served as a board-certified diagnostic radiologist at highly acclaimed healthcare centers, as a senior faculty member at leading academic institutions, and as a trusted scientific advisor to numerous global pharmaceutical companies.

LEARN MORE
CALYX-20-Headshots-PeterSteiger-FINAL

Peter Steiger, PhD

Chief Scientific Officer, Calyx

Peter has a wealth of experience in the use of imaging and other biomarkers for documenting the safety, efficacy, and effectiveness of new drugs in clinical trials. He leads Calyx’s Global Scientific and Medical Services team of over 75 scientists and is actively engaged in developing and implementing effective imaging strategies for global clinical development programs. He has authored numerous papers and is regularly involved in research presented at scientific meetings.

LEARN MORE
CALYX-20-Headshots-Oliver-FINAL

Oliver Bohnsack, MD PhD MBA

Vice President, Medical Imaging and Head of Oncology, Calyx

In leading the imaging component of oncology studies for Calyx’s global customers, Oliver leverages his experience from supporting over 600 clinical trials – with various indications, complexities, and in all phases of development – which led to the approval of over 20 oncology treatments. He is co-author of the immune-related response criteria (irRC, 2009), first author of irRECIST (2014), and co-author of Comparison of Assessments using RECIST and irRECIST by Eggleton P. et al. (2020).

LEARN MORE
CALYX-20-Headshots-Surabhi-FINAL

Surabhi Bajpai, MD

Associate Director, Medical Imaging Calyx

Leveraging her training in medicine and radiology, Surabhi has led the imaging components of approximately 50 oncology trials – both solid tumors and hematology malignancies –  and provided consultation on complicated aspects of standardized response assessment criteria. Her expertise in Multiple Myeloma, Lymphoma, and CLL enables her to provide clear guidance to clinical trial sponsors and communicate complexities of criteria to independent reviewers to avoid heterogeneity.

LEARN MORE

Jayant Narang, MD, DNB

Medical Director Oncology, Calyx

Having served as an independent reviewer and as a veteran board-certified radiologist, Jayant has a wealth of experience in using imaging to document the safety, efficacy, and effectiveness of new drugs in clinical trials. He has supported hundreds of hematology and oncology trials, multiple with immuno-oncology and CAR-T therapy, and frequently engages with KOLs to seek clarifications on response assessment criteria. He has presented abstracts with Dr. Bruce Cheson as co-author in the CLL space.

LEARN MORE

Minimize risks in clinical trial imaging. Contact us today.

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

Library

The MAH’s Guide to Preparing for IDMP

Read more

Brain Metastases from Solid Tumors: Implementing Response Assessments

Read more

Utilizing Medical Imaging to Support Accelerated Approval

Earning the FDA’s prized Breakthrough Therapy designation is just the beginning of the race, one that likely requires the use of an imaging surrogate for preclinical evidence and accelerated approval.
Read more

Ultimate Guide: IRT approaches to help with reducing drug waste

Read more