The success of your clinical investigation requires more than basic monitoring. At Biotex, we go above and beyond, offering a collaborative and committed partnership to ensure the highest standards of efficiency and quality in your clinical research.
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You don’t have to do it yourself!
Conducting clinical investigations is like navigating a maze. If you don't have the right team with the right resources to administer your study's crucial components, you can get lost in the process and compromise the results, wasting time and money.
Each clinical investigation requires specific equipment, robust staffing, regulatory expertise, and other essential resources to ensure successful outcomes. To conduct a well-facilitated clinical investigation, hiring a CRO is your best option.
A CRO will conduct your study from start to completion through expert staffing, providing adequate documentation and support to keep you informed at every stage of the process. It allows you to significantly reduce costs, save time, receive accurate reports to validate results, and meet your timeline.
Your peace of mind matters.
Delegating your clinical investigation to an expert team with the knowledge and training needed to achieve your goals means every stage of the process is meticulously facilitated to ensure strict compliance with regulatory standards for your specific study.
With an expert team working behind the scenes, your clinical investigation can run smoothly without delays, regardless of region or jurisdiction.
endpoint success rate from our most recent first in human early feasibility study for a vascular implant device in Panama, covering two centers and 10-15 subjects
We perform routine invoice tracking and reconciliation, allowing us to save our clients thousands in study costs. In just one study, we saved our clients approximately 50,000 dollars.
of collective clinical and regulatory experience, skills, and expertise allow our staff to conduct a seamless study with minimal supervision, providing efficiency, accuracy, and timely delivery
The Biotex CRO+ provides comprehensive study and site start-up support, offering robust services tailored to your specific needs. Our expert team excels in crafting essential documents, including protocols, investigator brochures, clinical risk assessments, informed consent forms, case report forms, monitoring plans, and more.
Our comprehensive approach encompasses routine data monitoring utilizing cutting-edge EDC systems, meticulous regulatory document reviews, and strategically conducted interim monitoring visits, including crucial stages such as the site initiation visit and rigorous source data verification checks.
Our services cover a comprehensive range of activities, including data management, adverse event reporting and reconciliation, review of site files, ensuring the completeness of all study documents, management of remaining investigational products, review of collected specimens, data analysis, and manuscript preparation and submission.
Our customized auditing services provide thorough assessments, guaranteeing adherence to the highest standards and establishing a collaborative partnership to enhance the efficiency and quality of your clinical investigations.
Our commitment extends beyond the audit as we collaborate with you to implement best practices, identify strengths, and offer strategic and continuous recommendations for improvement.
"Medwave is an imaging CRO dedicated to neuro-oncology research with expertise in implementing advanced imaging biomarkers in the tumor response evaluations to discriminate between true progression and radionecrosis/post-treatment effects. It is a true pleasure to work with Britnee supporting the set-up of the first-in-human phase-I study in Germany. We greatly appreciated to work with a CRO that has the knowledge and experience to translate a complex clinical study in a pragmatic approach to get the study started. This positive attitude combined with the friendly cooperation makes working with Biotex an experience to repeat."
John Uiters
CEO, Medwave Clinical Research B.V.
“Ictero’s success depends on the quality and speed of our clinical trials. That’s why we partnered with Biotex CRO+, with the experience and expertise to match our goals and challenges. Whether it’s setting up our first in human trial, working with clinical sites around the world, or navigating the regulatory requirements, they offer comprehensive and reliable services that help us accelerate our feasibility studies and increase our value.”
Ictero Medical
"Voyager Biomedical's experience with the CRO team at Biotex has been positive and beneficial. Biotex CRO+ communicated well with our internal team and the onsite OUS team to ensure that the investigation protocol was understood and followed appropriately and that the data collection and entry were done to a high standard. The Biotex CRO+ team's attention to detail and diligent monitoring assured us that we would have quality data and results that accurately reflected our experiences at the completion of our OUS first in human trial."
Voyager Biomedical, Inc.
"Working with Britnee is always a joy. She's a driven leader with a keen eye for detail, a knack for problem-solving, and a propensity for critical thinking. Our collaboration was both enjoyable and productive. I just loved having her on my team."
April Muñiz
University of Virginia - Multicenter Clinical Trial Project Manager
"We are pleased to express our sincere endorsement of Biotex CRO+ based on our collaborative experience in the Ark Cannulation Trial (ACT) for patients with end-stage renal disease undergoing hemodialysis. The team at Biotex demonstrated outstanding commitment and competency, which significantly contributed to the success and accomplishment of our clinical trial. Their proactive communication and dedication to quality make them an invaluable partner in advancing clinical research."
Margelis Muñoz
Managing Director, C&M Research
Our team has extensive expertise in diverse facets of clinical trials, such as proficiency in GDPR and HIPAA compliance. We currently maintain NIDA CTN GCP certifications and have previously held certifications from ACRP, including CCRA and CP, along with CITI GCP training.
Entrust your clinical investigation to an expert team that understands, values, and implements the highest standards in preparing accurate clinical documents, monitoring, and auditing for seamless regulatory approval.
Together, we can be part of your successful journey to bring your product to the market sooner.
