Clinical Trial Data Management ensures the collection, integration, and availability of clinical data. This involves verifying that the data is clean and free from errors, and includes activities such as data intake, cleaning, curation, and facilitating interoperability, including data transformation. It also supports the conduct, management, and analysis of studies across the spectrum of clinical research. The ultimate goal is to ensure that conclusions drawn from research are well supported by high-quality data.

Clinical Trial Statistical Programming enables clinical trial reporting by creating regulatory submission ready analysis datasets and producing Tables, Listings, and Figures (TLFs). This includes programming the clinical database and setting it up for data collection, as well as the use of languages such as SAS to analyze clinical trial data, create standardized datasets (e.g., SDTM, ADaM), and generate statistical outputs (TLFs). These deliverables support the understanding of the safety and efficacy of investigational products and help assess the outcomes of trial hypotheses.

Clinical Trial Biostatistics applies statistical concepts to design, execute, and analyze data from clinical trials. Its core function is the interpretation and validation of clinical trial datasets, including Tables, Listings, and Figures (TLFs). Biostatistics services also include support for protocol design, medical writing, regulatory submission and defense, helping to interpret data so that pharmaceutical companies and regulatory agencies can make informed decisions about a clinical program.

A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is an independent group of experts that provides Trial Monitoring services by reviewing accumulating data from an ongoing clinical trial. This committee, typically including clinicians and biostatisticians, assesses safety and efficacy data to make recommendations about continuing, modifying, or stopping a study. They provide independent oversight to protect patient safety.