What is a CRO?
Clinical Trial Management
CROs manage and conduct clinical trials on behalf of pharmaceutical and medical device companies. It involves coordinating various aspects of the trial, including patient recruitment, data collection, and regulatory compliance.
CROs can also assist in developing the clinical trial protocol (a detailed plan that outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial).
Regulatory Affairs
CROs can assist in navigating the complex regulatory landscape by helping companies prepare and submit regulatory documents to obtain approvals from Regulatory Authorities and Ethics Committees/Institutional Review Boards (EC/IRBs). Throughout this process, CROs play a vital role in ensuring compliance and facilitating the approval of clinical trials, ultimately advancing the development of health care.
Quality assurance and compliance
CROs can ensure all aspects of the research comply with regulatory standards and guidelines, including monitoring and auditing activities to maintain quality throughout the research process.
Continuous monitoring of quality metrics and reporting allows for proactive management, fostering a culture of quality and compliance throughout the clinical trial process, ultimately contributing to the generation of credible and reliable data for evaluating new medical products.
Site Selection, Initiation, and management
If you need assistance determining where to conduct research, CROs can help identify and select appropriate clinical trial sites. This process involves evaluating potential sites based on patient population, infrastructure, and experience.
Once sites are selected, CROs can facilitate the initiation process, ensuring all necessary approvals and documentation are in place. They can also continue to oversee and manage the various clinical trial sites, ensuring the sites are adequately equipped, staffed, and compliant with Sponsor requirements until the end of the study.
data management and biostatistics
Another essential service CROs can provide is handling the collection, management, and analysis of data generated during clinical trials.
CROs oversee data collection from various trial sites, which involves managing electronic data capture (EDC) systems, ensuring data accuracy and completeness. They may also perform statistical analyses to interpret the results and write final reports such as the Clinical Investigation Report and the final manuscript
WHy a cro is the
fastest path to market
Outsourcing functions to CROs provides companies with several strategic advantages, allowing them to concentrate on core competencies, streamline operations, reduce costs, and expedite the IP development process. By entrusting specialized tasks such as clinical trial management, regulatory affairs, and data analysis to CROs, companies can leverage the CROs' expertise and infrastructure, freeing up internal resources for more focused efforts on research and innovation.
Investing in a CRO enhances efficiency and often results in faster and more cost-effective development cycles. CROs bring a wealth of experience and knowledge in navigating regulatory complexities, ensuring that trials comply with standards. Additionally, the scalability offered by CROs enables companies to adapt quickly to changing project requirements.
Discover Biotex
Custom
EDC Building
We develop and construct studies within EDC systems, saving our clients up to 50K dollars in costs and valuable time, resulting in maximum efficiency and target delivery.
Beyond
Monitoring
We go beyond traditional monitoring. We also assist clients with protocol writing and development, regulatory submissions, data analysis, statistics, and more.
Quality Control
QMS
We utilize a quality management system compliant with the ISO 13485 standard to uphold quality control for all clinical documents.
Add More Value To Your
Clinical Trial Journey
Collaborating with a CRO accelerates the overall product development timeline, contributing significantly to the advancement of medical research and the timely introduction of innovative products to the market.
Establishing a robust partnership with a CRO+ is instrumental in optimizing better resources, managing risks, minimizing costs, complying with strict regulatory standards, and achieving more significant milestones crucial for successful product development and commercialization.
Partner With Us
Choose a CRO+ that does more. Entrust your clinical trial to an expert team that goes above and beyond to ensure a significant difference in your clinical journey.
Partner with Biotex CRO+ today.