You're probably thinking of grant-based educational research - don't worry, that's a common misconception. In contrast, clinical trial research aims to test the safety, efficacy, or effectiveness of medical interventions (e.g., drugs, devices) following protocols to improve health outcomes, often for regulatory approval or patient care advancements. Documentation requirements are similar to what you would do for a typical patient encounter.
Trials are designed with strict ethical oversight (e.g., IRBs) and phased approaches (Phase I-IV) to prioritize safety, starting with small, controlled groups. We typically seek out and recommend Stage III and IV studies or non-investigational products, until you're ready for earlier stages.
Regulations mandate clear, comprehensive consent forms, and ensure patients get verbal explanations too, tailored to their comprehension level.
Many trials allow delegation to staff, just like your normal practice. We can either train your nurse or provide one of our experts to you for encounters. And, if that's not enough, you can use our office with fully-equipped exam rooms.
Training programs (e.g., Good Clinical Practice certification) and collaboration with our team can bridge the gap quickly.
You've got everything you need. In fact, most studies prefer to provide most of the items to ensure consistency. Anything you don't have can be provided at no cost to you.
We work with study Sponsors ahead of time to ensure there are recruitment and marketing strategies in place on day one.
Most, if not all, providers prefer to have Premier Bioservices handle the more tedious paperwork. This is our service to you.
Most studies offer compensation to cover reasonable costs for participants.
Luckily, there are no CMS-1500 claim forms and clearinghouses to deal with. There are no prior authorizations or denials either. We will work with the trial sponsor to establish a payment schedule (budget), manage the billing for you, and pay you directly on a set schedule (usually per patient encounter).
The U.S. clinical trials market was valued at approximately USD 25.81 billion in 2023, with a projected compound annual growth rate of 4.88% from 2024 to 2033, according to Nova One Advisor. Our team has been conducting clinical trial research for over 20 years.
Large institutions face high overhead, bureaucracy, and delays, while smaller site networks offer lower costs and faster trial startups, appealing to budget-conscious sponsors (drug development costs: $100s of millions to $2B+). Smaller networks, often in suburban/rural areas, improve recruitment and diversity, addressing the 80%+ of trials failing to meet enrollment timelines, unlike urban-centric large institutions.
We don't like to brag, but chances are that if you've heard of them, we've worked with them recently. We communicate frequently with manufacturers and clinical research organizations to keep a pulse on the industry and prepare for future opportunities.
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