- Clinical Programming
- Data Management
- Medical Writing
- Clinical Data Admin
- Statistical Programming
Our Biostatisticians provide support across all assigned statistical tasks during the lifecycle of a project, including preparing Statistical Analysis Plans (SAPs) and the development of well-presented mock-up displays for tables, listings, and figures.
In our Biostatistics department we are responsible for meeting timelines and providing high quality deliverables that comply with contractual project requirements and Standard Operating Procedures (SOPs) and conducts projects within budget.
From protocols to regulatory submissions, as part of the Medical Writing team we take a product from conception to commercialization involving hundreds of thousands of pages of documentation. We take our work seriously knowing that this documentation must be written to exacting formats within strict timelines to drive delivery of important therapeutics.
Clinical Data Admin
Our Data Administration team are responsible for assisting in all clinical data management activities required for clinical trials, this means that accuracy and quality of our work is of vital importance.
Here, there’s no shortage of challenging work. We are always reviewing and adhering to the requirements of study-specific Clinical Data Management Plans for assigned project(s) and completing and submitting specific access forms and/or spreadsheets.
Our multi-skilled Statistical Programing team works on complex projects in the development of programs to support the conduct, statistical analysis, and reporting of projects. We create, test, and maintains programs for clinical studies. Our team is constantly collaborating on the overall strategy for the programming tasks on a project. We assist in managing project budgets and tracking project specific performance metrics. We use our voice and provide input to the statistical analysis plan. We lead the creation and maintenance of statistical programming project documentation.
Our experts are skilled with SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. We do all of this while validating programming and collaborating with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
We provide our business and colleagues with the intelligence that is integral to the success of our business. Worldwide and Country Specific Regulations & Guidance Documents are required to fulfil our obligations and to connect us all to Subject Matter Experts who can support with regulatory needs.
Our resources explore existing regulatory authority, industry websites, journals, and articles, as well as areas of special interest and identifying forthcoming regulation implementation dates and deadlines.