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Description

*Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Biostatistics and Programming Services

Inquiry

Innovations are made in the clinical trials all thanks to the coordination of biostatistics and programming that are relevant tools for conducting research and improving patient results. Protheragen regards as important these studies and services and devotes a considerable amount of time and other resources to the provision of such services.

Overview of Biostatistics and Programming

Biostatistics and programming represent the confluence of statistical science and computational technology, specifically tailored for the analysis and interpretation of biological and health-related data. Biostatistics is the application of statistical methods to the design, analysis, and interpretation of biological studies. It encompasses the planning of research studies, the collection and management of data, and the statistical analysis that leads to meaningful conclusions. Programming, in this context, is the technical skill set that enables the implementation of these statistical methods, the management of complex datasets, and the automation of repetitive analytical tasks. Together, they form the backbone of data-driven decision-making in the life sciences.

Biostatistics and Programming in Clinical Research

Biostatistics and programming specialists are vital at every stage of the clinical development life cycle. Their inputs include:

Study Design and Planning

Biostatisticians assist in the infrastructure of the study through collaboration to construct goals, objectives, endpoints, sample size and randomisation methods to be incorporated into the design.

Data Analysis and Reporting

The process of converting raw clinical information into datasets that are suitable for analysis is undertaken by statistical programmers in accordance with CDISC specifications, whereas biostatisticians conduct the required statistical analysis and prepare submission quality tables, listings and figures.

Safety Monitoring

Biostatisticians undertake analyses of data for blinding and non-blinding to assist the Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) in the assessment of safety and efficacy of the investigational products.

Integrated Summaries

Esteemed biostatisticians contribute substantially to the preparation of Integrated Summaries of Safety Document (ISS) and Integrated Summaries of Efficacy Document (ISE) in bid for regulatory approval.

Our Services

Protheragen has a well-experienced team that maintains the quality of services and develops and perfects all kinds of biostatistical and programming services, assisting the client at any stage of drug development.

Biostatistics Services

Study design and protocol development
Statistical analysis plan (SAP) authoring
Sample size calculations and power analyses
Adaptive and innovative trial design support

Data monitoring committee (DMC) and data safety monitoring board (DSMB) services
Integrated summary of safety (ISS) and integrated summary of efficacy (ISE) preparation

Statistical Programming Services

CDISC-compliant dataset programming (SDTM, ADaM)
Table, listing, and figure (TLF) programming
Submission-ready data package generation

Legacy data conversion to CDISC standards
Regulatory document support (e.g., define.xml, reviewer's guides)

Our Advantages

Therapeutic Expertise: Protheragen boasts an invaluable team of biostatisticians and programmers with considerable experience encompassing a broad range of therapeutic domains including oncology, difficult-to-treat conditions, and complex therapies.
Innovative Methodologies: Normative Engineering has expertise in contemporary statistical methods including adaptive designs, Bayesian methods, and real-world evidence analyses.
Quality and Efficiency: Protheragen's robust quality management system, centralized computing platform, and standardized processes guarantee the completion and delivery of all required documents within the specified timeline.
Collaborative Approach: In Protheragen, clinical development programmes are designed commencing from strategic input with biostatisticians and data analysts who offer their unique perspectives while working together with other teams.

Through the collaboration with Protheragen, clients can utilize the company's wealth of knowledge together with inventive approaches and dedication to excellence in order to traverse the intricate field of biostatistics and programming, which, in consequence, hastens the creation of life-altering therapies. If you are interested in our services, please feel free to contact us.