Boca Biolistics offers a full range of CRO services, ensuring you obtain the necessary evidence to gain regulatory approval. With state-of-the-art facilities and a global network of investigators, we have amassed a proven track record of getting diagnostics and therapeutics to market successfully. Our 20+ years of clinical research experience and dedication to the highest standards of quality have cemented our reputation among diagnostics and biopharmaceutical companies as a reliable partner.
As a CAP-accredited organization, we can streamline your clinical trial by combining clinical research services and central laboratory testing under the same roof. Working with Boca Bio avoids the testing roadblocks which add unnecessary cost and schedule overruns to clinical trials.
Regardless of whether you are looking for a full-service partner or focused assistance with a particular aspect of your trial, Boca Bio has both the capacity and flexibility to fulfill your trial needs. From the initial study design to the final regulatory submission, our team will make every step of the process smoother. We understand the importance of reaching your development milestones in the most effective, efficient way possible. We take an approach that mitigates the risk of each phase of your study, helping to determine the best course of action to keep your project moving forward. Where other companies might see stumbling blocks, we find solutions.
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Cost and schedule overruns plague clinical trials, with an estimated 85% of trials experiencing delays. Delays and exceeded budgets do not need to be norm. Through proper trial management, you can get the necessary data while enabling timely regulatory approval and commercialization. Our qualified team of project managers can help oversee every phase, mitigating the risk of late-phase failure. At Boca Biolistics, good management also means transparency, and we provide thorough and regular status to keep you abreast of project status at every step of development.
We know that successful trials start with selection of the sites and investigators who have the experience and patient population to meet the study's goals, which is why we use data-backed research to identify the optimal sites for each clinical trial. We do the groundwork to ensure you meet your enrollment targets on time, and can manage the full site lifecycle from selection through closeout for every stage of your clinical trials.
Boca Biolistics holds data management as a core competency, and we manage a sets on a routine basis. Data analysis, data management, and security are all second-nature to us, and our SOPs for handling clinical data always follow the latest ICH GCP guidelines.
Our network of principal investigators covers five continents and over fifty countries. That network continues to grow. Our database of sites and investigators allows us to quickly identify rare global patient populations, pinpointing site selection for clients and increasing patient enrollment.
Our consulting services help prepare your regulatory submissions, identifying weaknesses and eliminating them before they end in rejections. Our teams have experience working with a long list of global regulatory bodies, including FDA, Health Canada, EMA, MHRA and more. BocaBio is also preparing for the EU's new MDR and IVDR directives, which will replace the current IVDD (98/79/EC) directive by May 2022.
Patient recruitment has always been a key challenge, and as trials have become more complex, subject retention has further challenged the ability to sponsors to meet their endpoints. Over half of clinical trials are delayed due to patient recruitment issues, and 30% of enrolled subjects ultimately drop out. Enrollment and retention of patients are vital to the success of a clinical trial, but that success does not begin at enrollment. It begins at study design and site selection. We put data to work to minimize enrollment risks for your trials, better enabling us to meet your timelines and providing a better chance of meeting your trial's endpoints. The more success we can deliver for our clients, the better care our clients can deliver for patients.
For over 20 years, Boca Biolistics has been involved in the development of new diagnostic products, from concept to market. We combine our expertise in data management, regulatory submissions, laboratory testing, and patient care to provide both customized and end-to-end CRO solutions. The result is lower development costs, faster time-to-market, and reduced risk of late-phase failure for our clients.
We're passionate about science and working with like-minded scientific organizations to provide a higher quality of life to patients globally. Everything we do has that end goal in mind.
No matter the size or scope of your next initiative, we have the services and staff to see it through. Contact Boca Biolistics and propel your diagnostic and therapeutic pipelines forward.