SDC (Statistics & Data Corporation)

The decision makers in SDC (Statistics & Data Corporation) are Adam Hamm, Cheryl Reigle, Daniel Lugo, etc. Click to Find SDC (Statistics & Data Corporation) decision makers emails.

SDC Clinical provides a comprehensive range of clinical trial services tailored to the needs of pharmaceutical, biologic, and medical device companies. Our offerings include consulting, biostatistics, data management, clinical research, EDC technology, eClinical solutions, data monitoring committee services, and interactive response technology (IRT/IWRS). Each service is designed to ensure the successful execution and management of clinical trials, from planning to data analysis.

At SDC, we prioritize data integrity and quality throughout the clinical trial process. Our experienced teams implement rigorous data management practices, including regular monitoring and validation of data, adherence to regulatory standards, and the use of advanced EDC technology. Additionally, we conduct thorough quality assurance checks and maintain open communication with our clients to address any concerns promptly, ensuring that the data collected is reliable and actionable.

SDC supports a variety of industries, primarily focusing on pharmaceutical, biologic, and medical device/diagnostic sectors. We understand the unique challenges and regulatory requirements of each industry, allowing us to provide specialized services that cater to the specific needs of our clients. Our expertise enables us to assist companies at various stages of product development, from early-phase trials to post-marketing studies.

Yes, SDC offers consulting services that include guidance on regulatory submissions and compliance. Our team is well-versed in the requirements set forth by regulatory agencies, and we work closely with clients to prepare the necessary documentation and data for successful submissions. We also provide support in navigating the complexities of regulatory processes, ensuring that our clients meet all necessary compliance standards throughout their clinical trials.

The Data Monitoring Committee (DMC) plays a crucial role in overseeing the safety and efficacy of a clinical trial. At SDC, our DMC services involve independent review of trial data at predetermined intervals to assess participant safety, treatment efficacy, and overall trial integrity. The DMC provides recommendations based on their findings, which can lead to modifications in the trial protocol or even early termination of the trial if necessary. This independent oversight helps to ensure that the trial is conducted ethically and that participant safety is prioritized.

Interactive Response Technology (IRT/IWRS) is a system used to manage randomization and drug supply logistics in clinical trials. SDC utilizes IRT/IWRS to streamline the process of assigning participants to treatment groups and to monitor the distribution of investigational products. This technology enhances operational efficiency, reduces the risk of errors, and improves the overall management of clinical trials. By implementing IRT/IWRS, SDC ensures that our clients can effectively manage their trial resources and maintain compliance with regulatory requirements.