Data Management and Statistics

With a wealth of experience spanning Phases I-IV, our well-established biometrics team has handled many international clinical studies in a wide range of therapeutic areas. Using Oracle Clinical™, Clintrial™ and SAS®, and working to our own ICH-compliant SOPs, or to those of a customer, we combine a quick turnaround with high accuracy. We collaborate fully with research and product development teams and structure our support to suit our clients’ individual needs. Electronic Data Capture (EDC) services are available through Oracle Clinical Remote Data Capture™.

Our biometrics team has worked on numerous studies, processing data collected from many thousands of subjects in Europe, the U.S., Canada, Australia, and South Africa. Skilled in dealing with national regulatory bodies such as the FDA, EMEA, MHRA, and BfArM, the team has undergone numerous audits, including an MHRA voluntary audit and external systems audits.

Our experienced statisticians can provide customized statistical consultancy support in all areas of drug development, whether it is advice on non-clinical studies, clinical studies, or regulatory submissions. From study design to reporting, we offer a comprehensive range of biometrics services:

Case Report Form (CRF) Review

We believe that early review of the CRF by our Data Management and Biostatistics teams is critical to optimizing the overall data management process. An early review allows us to identify sources of potential errors or inefficiencies in data collection, CRF monitoring, and data entry. Our teams can offer alternative approaches based on their extensive experience with CRF design and data management across a broad range of therapeutic areas. Regardless of whether Constella is doing the clinical monitoring, we still advocate review of the CRF by our Data Management and Biostatistics teams.

Data Management Strategy

Constella can develop the initial data management strategy for individual studies or for multiple studies in a development program. We can advise our clients on the most efficient approaches for their project, from determining CRF retrieval schedules to preparing strategies for providing data for interim analyses. Our Data Management teams work collaboratively with Clinical, Biostatistics, and Medical Writing groups to assure that all groups have cross-functional understanding of specific project issues as well as the overall objectives of the project.

Database Design and Data Management

Constella has a proprietary data management system that is fully validated and Part 11 compliant. This system allows each database to be customized to our client’s specific project needs. The database structure is flexible, and outputs can be provided in SAS or in other formats as requested. We provide a full array of reports that track the status of each of our key steps in the CRF retrieval, data entry, data cleaning, and verification process. These reports can be customized to individual client requirements and provide a comprehensive, up-to-date view of the project status.

Medical Coding

We provide medical coding services for specified drug and disease variables using dictionaries agreed upon with our clients. Our staff are trained to provide coding in MedDRA, COSTART, WHODrug, and WHOArt, and we have experience using each of these dictionaries. Our medical directors provide medical input to this process as needed.

Statistical Consulting

We offer statistical consulting services for overall clinical development programs, individual protocol designs, and integrated summaries for regulatory submissions. These services include selection of endpoints and statistical methods, determination of sample size and power calculations, and participation in FDA and European regulatory authority meetings.

Statistical Analysis Planning

Our services include the development of the initial statistical analysis plan for individual protocols or for integrated summaries of safety and efficacy. Each statistical analysis plan includes a detailed description of the analyses to be performed, an outline of the planned tables, listings, and figures, and shell tables and listings.

Statistical Programming

We offer full statistical programming services in SAS®.

Statistical Reporting

Our Biostatistics group has extensive experience in the conduct of statistical analyses and preparation of statistical reports for individual studies (Phases I-IV) and for integrated summaries of safety and efficacy. Within each project, our Biostatistics team is integrally involved with Clinical and Data Management teams, to assure that it has an in-depth understanding of key project issues and an overall awareness of the end-goals. Our statistical reporting capabilities are flexible and can include preparation of the statistical section of clinical study reports or integrated documents, or simply the tables, listings, and figures as defined by the statistical analysis plan.

Using WinNonLin® or SAS®, non-compartmental and compartmental pharmacokinetic modelling can be performed.