The needs of small to mid-market biotech are different. Your CRO should be different too.

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Oncology-focused.

Highline Sciences is a specialized, full-service CRO and consultancy founded from within an oncology biotech to provide a better solution. We understand the gap between what you need and what you get from a traditional CRO and we’re here to improve the status quo.

A fresh and unique approach.

Highline Sciences was built specifically to address the common problems that biotechs encounter with CROs. The combination of our corporate infrastructure, focus, and passion enables us to deliver higher-caliber, more engaged teams and allocate them appropriately to each project. This means that our Sponsors and research sites receive, and retain, A-team support and the attention they deserve from IND to market approval.

Our Approach

We believe that science has the power to save lives—and every day counts.

We help innovators run smart development programs to reach critical milestones quickly and cost-effectively. We understand your challenges because we’ve lived them and our services are designed to ensure you get exactly what you need with the flexibility required for complex & adaptive trial designs, globally, from Phase I to Phase III.

Our Solutions

Proven Results

We are fortunate to have supported some of the most innovative biotechs with their development of breakthrough discoveries and lifesaving treatments. Our clients are BioSpace “startups to watch”, FierceBiotech Fierce 15 winners, companies with breakthrough therapy-designated products and companies working on cutting-edge immunotherapies, cell-therapies, biologics and small-molecules. From the planning of their first-in-human trials to the conclusion of their global, pivotal trials, market applications and inspections, we’re proud to say they have recognized the Highline difference.

We are honest and transparent, in good days and bad. Every project we design is personal. We are truly invested in the success of our partners and clients from concept through execution.

Our Ethos

Our visionary biotech partners strive to impact disease with cutting-edge science and we work alongside them, with unrelenting dedication.

We believe in the power of relationships.

We are an agile team of industry veterans with decades of experience supporting and leading clinical development at clinical site, CRO and Sponsor organizations. Our leadership has led multiple products from pre-IND to commercial approvals at biopharma companies as well as CROs. We recognize that the relationship between Sponsors, research sites and the outsourced team has been strained. We are passionate about improving the experience, quality and results for oncology-focused biotech and truly understand how to partner with industry and with clinical sites to execute a quality clinical trial with excellent customer service.

“Highline is not a typical CRO: They are a Partner committed to executing high-quality clinical trials. While working with Highline on a global, phase 2 trial, they dissuaded me of my prior experience that CROs require ongoing (and time-consuming) oversight and management.

- Senior Director & Head, Clinical Operations 
- Senior Director & Head, Clinical Operations

“Highline should be managing all of our studies”

- Data Manager, Oncology 
- Data Manager, Oncology

“They are thoughtful, detailed, organized, and efficient. They are aggressive in their pursuit of achieving milestones and surpassing deadlines, and it is rare that I have asked a question that they have not already considered themselves. They consistently demonstrate their expertise, and their sincere investment in the success of the study. “

- Clinical Operations Lead, Oncology 
- Clinical Operations Lead, Oncology

“Compared with other CROs, I really saw a difference during preparations for our interim analyses. Highline understands what’s important from a sponsor’s side. Their CRAs are committed to getting the data in with queries resolved on time”

Clinical Operations Manager, Oncology 
Clinical Operations Manager, Oncology

“Working with Highline has made it clear how much of a difference it makes to have an experienced CRA team”

- Clinical Operation Manager, Oncology 
- Clinical Operation Manager, Oncology