Elias Research Associates started in 2010 on the founding principle that clinical research sites could greatly benefit from extensive and robust administrative support.
The primary focus of clinical research sites is conducting trials for pharmaceutical companies. Clinical trials can also be sponsored by biotech firms, medical device manufacturers, or government agencies. This task is not only a monumental undertaking but also critically important to advancing medicine.
Clinical trials must follow a specific protocol – a comprehensive plan that outlines the trial’s procedures, objectives, and rationale. Not only are there FDA standards that guide how every clinical trial must be conducted, but each sponsor defines strict guidelines that govern everything from record-keeping and disclosures to patient eligibility and safety measures.
For example, to attain approval from the FDA, a potential drug must undergo testing across three phases. In Phase 1, the tested drug is administered to a small group of healthy volunteers to establish safe dosages and assess any adverse effects. In Phase 2, a limited number of actual patients are given the drug to evaluate its effectiveness and ongoing safety in treating the targeted condition. Should the drug demonstrate promise, Phase 3 expands the trial to a larger patient cohort, comparing its efficacy against placebos or existing treatments. Finally, if the drug passes the first three phases, phase 4 studies are initiated to monitor the drug’s real-world performance, ensuring continued safety and efficacy in broader patient populations. Phase 4 trials help the FDA and the sponsors understand how the drug performs outside a controlled trial environment.
Every clinical trial, whether to approve a drug, evaluate a medical device, or test a screening methodology, must be designed to gather reliable and replicable data. Consequently, research sites must possess expertise in running trials and establishing procedures that help them conform to the sponsor’s trial parameters for a particular trial or phase.
However, a research site’s expertise on the clinical side is very different from the expertise needed to operate the research site as a business proposition. This is where the services of Elias Research Associates are crucial.
Streamlining the Process for All Involved
Elias Research Associates is an experienced Study Management Organization (SMO) that offers clinical trial management solutions to pharmaceutical, biotechnology, or medical enterprises, serving the interests of both trial sponsors and research sites.
We work to optimize operational procedures for sponsors by matching them with qualified trial sites. We work on behalf of hundreds of research sites to assist with operations for which they often lack sufficient staff, expertise, or established connections. We help with business development, enabling them to identify and capture clinical trial opportunities that match their profile. Once a sponsor selects a site in our network, Elias Research will assist and advise the site with budget development, contract negotiations, invoicing, and payment management. Our expertise spans every aspect of trial start-up, and that expertise is placed at the service of the research site.
At every stage, Elias Research acts with transparency and promptness. With Elias Research Associates, sites can focus on their core clinical functions, relying upon us to provide administrative management and follow-up. We provide CROs with a seamless experience, using our business development, contract, and financial expertise to relieve sites from having to expend resources on these functions.
Our experience and reputation in the industry translate to immense benefits for the sites that choose to work with us. A site can join our network and begin receiving new study opportunities without any up-front cost.
We are committed to 100% transparency in all dealings with our research sites, including budget and contract negotiations. Because communication is our forte, every step of study start-up will be quicker and smoother, and we guarantee prompt communication – usually within 24 hours. This means the business development timeline can be reduced significantly, enabling sites to handle more trials with less downtime.
Joining our network provides research sites with risk-free support, earning them new studies, better budgets, and more profitable trial operations. Please click here to learn more about our process or join the Elias Research Network.