We’re here for you.

;

We get the job done.

Whether you need full-service clinical trial support, functional support or individual resources so you can do your best work, our goal is to help you reach yours.

Our objective is deep partnerships to provide A-team support across your development programs, globally, from Phase I to Phase III.

Full + Functional Global Services

Project
Management

Feasibility +
Site Identification

Study Startup
 

Investigator
Payments

Regulatory
 

Clinical Monitoring
+ Site Management

Medical Affairs
 

Safety + Pharmacovigilance

Data Management
 

Biostatistics
 

Medical Writing
 

Quality Assurance
 

Staff Augmentation

Indicational experience, geography, and the complexities of timing—we understand the myriad of challenges when searching for the right individuals to move a team forward, toward a new clinical solution. We work closely with you to evaluate existing staff, determine which additional skills are required, and identify industry experts and specialists to augment, and compliment, your workforce; at all levels, at any time, seamlessly.

Clinical Development
Consulting

Early-stage companies

You are just getting ready to begin clinical development and need help to prepare for and manage the process but it doesn’t yet make sense to hire staff. Highline Sciences has a strong track record of providing part-time or full-time clinical consulting services to new companies. We will work with you to provide thorough and tailored services that help you plan, forecast, and execute your clinical trials.

Established companies

You have ongoing programs in the clinical development stage but you need a little extra support. Our consultants have experience managing clinical programs and trials for sponsor companies like yours and have the skills and know-how to deliver any level of support you may need.

Systems

Veeva Vault eTMF and CTMS

By utilizing the Veeva Vault CTMS and eTMF systems, we are able to integrate processes and streamline our studies from site activation through close-out within one system. This approach increases visibility, quality and efficiency throughout the study lifecycle.

Oracle Argus Safety

We utilize Oracle’s Argus Safety, the industry leading adverse event management system. Highline’s Argus Safety database can be easily configured for a single study or for multiple studies and/or compounds depending on your needs. Significant cost savings and improved safety oversight can be achieved by centralizing your safety data with Highline within a sponsor-specific Argus Enterprise. All study-specific configuration is completed in-house by Highline Sciences which allows us to offer more flexibility and responsiveness to our sponsors.

Electronic Data Capture (EDC)

Medidata RAVE and Medrio are our preferred EDC systems due to their flexibility in design along with ease of use for site staff. Data are readily visible and available for reporting, improving your ability to analyze and make key decisions throughout a clinical trial and the flexibility of these systems are particularly important for complex, oncology clinical trials.