Welcome to Carmel Research Consultancy
In the world of biomedical research, the reliability of predictions hinges on well-executed studies supported by robust statistical tools. At Carmel Research Consultancy, we understand that accurate predictions drive decisions in fields like public policy and strategic planning. Biostatisticians play a crucial role in ensuring public health and enhancing lives through quantitative research. By collaborating across quantitative disciplines, biostatisticians work with other biomedical researchers to tackle health threats and enhance quality of life.
Carmel's statisticians collaborate with regulators across diverse therapeutic divisions, navigating both standard and alternative regulatory paths, such as orphan, breakthrough, and fast-track designations. Our team manages timelines, handoffs, communication plans, and milestones, ensuring a seamless coordination across data vendors and functional areas. Their responsibilities encompass various tasks, from generating randomized schedules to crafting CDISC-compliant data packages. We pride ourselves on our history of successful regulatory submissions and a team with diverse therapeutic experience.
High-quality patient data is paramount for regulatory success, demanding rigorous management to ensure data integrity, compliance, and safety. At Carmel Research Consultancy, our focus on flawless execution from planning through operations ensures minimized risk and optimal outcomes. Our biostatistics and statistical programming capabilities, coupled with deep expertise in complex therapeutic areas, guarantee robust study design and execution. We offer flexible engagement models to suit your needs, acting as your primary statistical team or providing supplementary support and oversight.
Our expertise extends to crafting CDISC strategies aligned with your corporate, financial, and regulatory objectives. With a history of developing CDISC-compliant datasets for numerous studies, we excel in handling ongoing studies, legacy conversions, and programming specifications for SDTM and ADaM domains. We offer a comprehensive range of services, from SDTM annotated CRFs to crafting Define.xml files for SDTM and ADaM. Our experienced team ensures that your study data meets the highest quality standards.
Collaborating with Carmel Research Consultancy starts by aligning objectives from regulatory, corporate, and scientific perspectives. Our team then weaves these objectives into powerful study designs that prioritize key goals and strategically mitigate development risks. Our biostatistical consulting services cover various aspects, including study design, regulatory support, strategic product development plans, and exploratory analyses. Our team ensures that your study's design aligns with your objectives and that you have the support you need for decision-making during challenging situations.
A dynamic ensemble of experts, dedicated to shaping innovation and excellence in pharmaceutical and medical.research.
