Data science is a critical part of drug development. During clinical research studies, a significant amount of data is generated, which needs to be carefully processed, analyzed, interpreted, and reported. In order to make crucial decisions during a clinical study, high-quality data is needed quickly.
At Quotient Sciences, our Data Sciences department supports clinical trials conducted at our Miami, US, and Nottingham, UK, clinics, providing customers with rapid data and results to inform and accelerate their drug development programs. Faster data means that we can provide earlier interim data and pharmacokinetic (PK) reports for on-study dosing that aid in formulation development decisions.
We understand that on-study changes to early-phase trial designs and dosing are common, so we take a flexible and adaptive approach to meet those demands. Our data science experts work to global standard operating procedures (SOPs), templates, and standards, but these can also be adapted to align with sponsor templates and standards where required. We place a great deal of emphasis on implementing industry-leading systems and software to drive data quality and reporting in line with customer expectations and industry standards. Our services are fully integrated, and we assign a single project manager for all drug product, clinical, and data science activities.
The Data Sciences department at Quotient Sciences is comprised of six key functions.
The electronic Case Report Form (eCRF) is a collection of digital forms used in clinical research to collect data about study participants. The Database Programming team sets up and maintains the eCRFs for all the clinical studies carried out at Quotient Sciences, including making design amendments as required. The team also uses Statistical Analysis Software (SAS) to program complex data checks and load external data, such as safety laboratory data, for reconciliation with the eCRF.
The Data Management Plan (DMP) is an important document that outlines how you are planning to manage your clinical research data, both during and after your study. The Data Management team at Quotient Sciences is responsible for the DMP, as well as data cleaning, reconciliation of serious adverse events (SAEs) and external data, coding, and query issue and review. The team also manages the database close/lock at the end of a clinical study, to prevent further changes to the database in preparation for data analysis. The Data Management team is also responsible for the generation of interim safety data listings for rapid dose decision meetings.
The Statistics team at Quotient Sciences provides input on the clinical study protocol, including sample size calculation and randomization. The team also manages the Reporting and Analysis Plan (RAP), which describes all the planned data analyses and output requirements for a clinical study, and performs formal statistical analysis and interpretation of study data.
The Statistical Programming team is responsible for programming Clinical Data Interchange Standards Consortium (CDISC) datasets, including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), and define-XML, as well as study listings, tables, and figures. Using SAS software, the team also loads data from the analysis of clinical study samples by Quotient Sciences’ Bioanalysis team or external vendors.
The Pharmacokinetics team derives PK parameters, which assist in characterizing how the drug is absorbed, distributed, metabolized, and eliminated from the body, such as the area under the plot of plasma concentration of a drug versus time after dosage (AUC) and the highest concentration of a drug in the blood after dosage (Cmax), using Phoenix WinNonlin software. This data is used for interim and final PK reports. The team also analyzes and interprets the images from gamma scintigraphy studies that are performed at our Nottingham, UK, clinic.
The Medical Writing team are a core part of the Data Sciences department, responsible for writing the clinical study protocol, including any protocol amendments and the final clinical study report (CSR) for all the clinical studies carried out at Quotient Sciences.
All functions play a key role in delivering crucial clinical trial data in order to streamline the drug development process for our customers and accelerate their molecule to their next project milestone.
Find out more about Data Sciences at Quotient Sciences by clicking the link below: