We are a full-service CRO that takes a solutions-based approach to each client's unique situation.
The pressure on clinical research departments has never been greater. Trials have become more complex and costly. Timely completion and cost-efficiency are paramount to the projected return on investment. Emerging companies face the same challenges as larger established organizations with more constraints on resources and budgets.
Our goal is to deliver excellent, efficient, and cost-effective solutions that allow our clients to focus on the planning and strategic direction of their overall clinical program; leaving the details to us. We're not your typical CRO. We offer personalized, customized, and rational solutions.
Conducting clinical trial feasibility is both an art and science. The science comes from the disease area, study design, and patient population. The art comes from collation and evaluation of historical trial data and the experience to assess.
Talk about a function that has seen significant change over recent years. Gone are the days of 3-part NCR, sticky notes, and manual tracking of patient accrual and progress. Automated systems, electronic medical records, EDC, risk-based monitoring – all have impacted clinical study monitoring.
Led by a 25-year industry veteran, our biostatisticians provide statistical consulting services across all clinical study phases and designs for pharmaceuticals and devices. Involvement at the early stages of protocol development ensures proper design, adequate sample size, and definition of primary and secondary endpoints.
No doubt about it. Clinical research creates a ton of data. And somehow, the data has to be transformed into documentation at all stages of the development cycle for evaluation by internal management, therapeutic experts, and regulatory authorities. It’s more than just printouts. A concise, accurate story has to be told.
Your study can be conducted flawlessly, but if the data integrity comes into question, it can be all for naught. And, with the complexity of today’s trials, improper design of your data collection and study database can result in headaches, delays, and cost overruns.
Clinical trials often run for months or years. Personnel at the clinical site and Sponsor come and go. The documentation trail has to be the primary source of what occurred during the course of your trial.
Our medical monitors possess significant experience across multiple therapeutic areas – providing keen insights during protocol development by identifying operational issues/trends during conduct.