Services Start-up services

Our commitment to excellence extends beyond mere promises. We take pride in offering a comprehensive suite of start-up services designed to elevate your clinical trial endeavors. Our dedicated team of experts specializes in study and site start-up activities, providing diverse services meticulously crafted to address your unique requirements.

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Precision and Rigor in Trial Conclusion

document crafting excellence

Biotex CRO+ is built with a team of seasoned professionals skilled at creating essential documents that form the backbone of any clinical trial. From meticulously drafted protocols and investigator brochures to comprehensive clinical risk assessments, informed consent forms, case report forms, and detailed monitoring plans, we leave no stone unturned to ensure the highest quality of your submission materials.

Our commitment to delivering premium services extends to the tools driving your clinical trial success. In addition to expertly crafting essential documents, our capability to manage Electronic Data Capture (EDC) systems, built for seamless data collection tailored to the unique requirements of a study, is an additional value we bring to our clients.

We also ensure sites are strategically chosen and thoroughly qualified for your specific trial requirements. Our comprehensive site selection process sets the foundation for a successful start-up, making sure your selected sites align with your study goals.

At Biotex CRO+, we guarantee all necessary documentation is in place prior to each site’s activation. This includes, but is not limited to, Clinical Trial Agreements (CTAs), Financial Disclosure Forms (FDFs), Delegation of Authority Logs (DOALs), Training Records, Curriculum Vitae (CVs), Medical Licenses (MLs), GCP Certifications, study insurance documentation, and more. By proactively addressing these elements, we set the stage for a smooth and efficient start-up process.

Meticulous Planning for Success

Biotex CRO+ recognizes that the success of any clinical trial is integrated into meticulous planning. Our team is well-versed in developing strategic plans that pave the way for seamless progress throughout the study.

We have a dedicated regulatory team with expertise in FDA, EU, and other regulatory authority submissions, offering unwavering support and ensuring that your study aligns with regulatory requirements and standards, including applicable privacy laws such as HIPAA and EU GDPR.

We also understand the critical role of statistical planning in the early stages of a clinical trial. To achieve success, we provide comprehensive statistical services crucial to decision-making processes for enrollment goals, endpoint determination, and other essential factors. Such services are integrated seamlessly within the clinical documents and ready for approval submission.

Our team's commitment extends to timelines and budgetary requirements. We ensure that every aspect of the planning process is strategically executed and adheres to predetermined timelines and budget constraints.

At Biotex CRO+, our dedication to efficiency and fiscal responsibility allows us to deliver successful clinical trial outcomes. We understand the critical nature of each phase and leverage our planning expertise to conduct your study with the robust foundation it needs to succeed.

Accurate documentation for definitive results

Clinical trials demand precision in documentation. At Biotex CRO+, we're proud of our unparalleled commitment to accuracy, allowing you to evaluate the results of your investigation confidently and effectively.

why choose Biotex

For your study start-up?

Expert

Biotex CRO+ boasts unmatched expertise from our seasoned clinical team. We are well-versed in the intricacies of study start-up activities, giving you confidence and peace of mind when you entrust your project to our capable hands.

Seamless

Choosing us means entrusting your business to a partner dedicated to facilitating the seamless progression of your clinical study, which can lead to meaningful, actionable, and definitive outcomes.

Personalized

We tailor our services to accommodate specific requests based on your needs without complex and unnecessary queues or paper trails. Our size allows us to be more agile, accessible, and flexible, saving you time and resources to help you accomplish your goals efficiently.

Start Your Journey Now

Embark on your clinical trial journey with confidence. Trust our expertise, accuracy, process, and commitment to the highest ethical standards to achieve a successful study start-up.

Contact Our Team