CRO Capabilities

Background and Capabilities:

We are a turn-key specialty CRO dedicated to the management and execution of well-designed clinical trials. We provide dedicated professionalism that adds value and unique expertise to your research needs. Since our inception in 1997, we have conducted or participated in over 500 Phase II to Phase IV clinical trials, including the management of over 56 FDA-regulated clinical trials ranging in size from 20 to 362 subjects. We specialize in headache and pain disorder clinical trials and have provided site management for the supervision of 44 migraine and headache studies. We are equipped to provide a wide range of CRO services including study design and optimization, site identification and selection, site contracting and budgets, source/EDC creation, e-diary development, monitoring, CDISC compliant data management, on-demand eLearning modules, statistical analysis planning, and strategic publication execution. Our experienced team of physicians, monitors, compliance experts, and data managers work together to implement pragmatic approaches to trial management.

We know the importance of delivering quality data to sponsors and take pride in our ability to design databases and datasets to meet the unique needs of each trial while creating systems to reduce the burden of siloed research. Our commitment to quality clinical research is enhanced by our active membership in leading clinical research societies such as the Society for Clinical Data Management (SCDM), MAGI, Society for Clinical Research Sites, and gold membership to the Clinical Data Interchange Standards Consortium (CDISC). We focus on quality clinical trial execution by emphasizing the use of technology to streamline processes and provide prompt reporting, all while meeting deadlines and respecting financial constraints. A strong sense of professional pride, responsibility, flexibility, and advancement to patient care permeates our company. We are dedicated to the success and timely completion of your clinical trials from inception through publication.

Site Communication:

Communication is key to successful clinical trial conduction. We pride ourselves in our commitment to effective communication with sponsors and trial sites. Open lines of communication reduce errors and improve protocol compliance throughout the trial.

Site Management:

We focus on efficiency, minimizing overhead, and respecting budget restraints. Unlike larger CROs, our multidisciplinary staff is uniquely aware of the entire clinical research cycle, including the unique needs of sponsors, and strives for rapid completion of key trial timelines, saving sponsors time and money.

Regulatory Adherence:

Network of trial sites with a strong dedication to producing quality data through enrollment of qualified volunteers and active involvement of investigators at each site.

Site Location:

Unique site-level perspective which allows for efficient and effective site management and trial execution.

Data Capture:

We integrate feedback from our investigators, sites, and sponsors to continually improve trial design, enrollment, retention, and trial flow. Overall increasing the satisfaction of our investigative sites, reducing errors, and respecting the financial needs of sponsors.