ADVANCED STATISTICAL INSIGHT & PROGRAMMING PRECISION

We offer a wide range of randomization methods, including simple, block, balanced, and stratified randomization approaches. The reliability and accuracy of our randomization algorithms are thoroughly documented and validated. Included is all documentation as per the CDISC TMF reference model. Our randomization methods can adapt to the extension of randomization lists, providing flexibility for adaptive study designs or protocol amendments.

Our team is experienced in preforming blinded and unblinded interim statistical analyses, including dynamic adjustments such as sample size re-estimation, and extending randomization lists. We also provide support for data safety monitoring boards as well as for analyses for dose limiting toxicity. We ensure efficient and timely deliverables aligned with study objectives and ethical considerations, including resource allocation or timely trial termination.

Statistical programming services are at the core of transforming raw clinical trial data into actionable results. Proficient in industry-leading statistical software, our skilled clinical programmers deliver regulatory-compliant solutions, including submission-ready SDTM/SEND/ADaM mapping and database creation per CDISC and regulatory standards. Our streamlined and automated programming process expedites workflows, minimizes errors and ensures regulatory compliance.

Our biostatisticians perform sample size calculations by assessing study objectives and provide support for clients through systematic literature reviews (especially if the effect size is uncertain). Every sample size calculation process is validated, ensuring accuracy and providing a solid foundation for your clinical trial.

Our adaptive designs are gaining popularity for their ability to incorporate planned modifications in study design based on data collected from subjects. This proactive approach provides solutions for various clinical study issues that can significantly impact costs and outcomes, such as sample size concerns involving underpowered or excessively large studies, or exposure to suboptimal drug doses in dose escalation studies. Our biostatisticians are well experienced in planning and conducting adaptive study design solutions.

At Wemedoo, statistical analyses are performed by PhD level biostatisticians with expert medical backgrounds. We ensure results reliability through rigorous statistical quality control, fostering confidence in the validity of the analysis methods and results. This meticulous approach spans the analysis of safety, efficacy, and other crucial outcomes, guaranteeing accurate and robust analytical findings. All work is performed in compliance with regulatory and ICH E9 guidelines.

Our expert team seamlessly integrates biostatistics, clinical programming, and medical writing to compile detailed and regulatory-compliant reports. From creating Statistical Analysis Reports (SAR) to precise Tables, Listings, and Figures (TFLs), or Integrated Summaries of Safety/Efficacy (ISS/ISE), we ensure a comprehensive approach in complete compliance with all international guidelines and regulatory standards.

We offer a wide range of randomization methods, including simple, block, balanced, and stratified randomization approaches. The reliability and accuracy of our randomization algorithms are thoroughly documented and validated. Included is all documentation as per the CDISC TMF reference model. Our randomization methods can adapt to the extension of randomization lists, providing flexibility for adaptive study designs or protocol amendments.

Our team is experienced in preforming blinded and unblinded interim statistical analyses, including dynamic adjustments such as sample size re-estimation, and extending randomization lists. We also provide support for data safety monitoring boards as well as for analyses for dose limiting toxicity. We ensure efficient and timely deliverables aligned with study objectives and ethical considerations, including resource allocation or timely trial termination.

Statistical programming services are at the core of transforming raw clinical trial data into actionable results. Proficient in industry-leading statistical software, our skilled clinical programmers deliver regulatory-compliant solutions, including submission-ready SDTM/SEND/ADaM mapping and database creation per CDISC and regulatory standards. Our streamlined and automated programming process expedites workflows, minimizes errors and ensures regulatory compliance.

At Wemedoo, all of our biostatistical processes, including statistical analysis, clinical programming, and reporting strictly adhere to regulatory standards set by authoritative bodies such as EMA, FDA, PMDA, and NMPA. Additionally, we align all of our practices with ICH pharmaceutical industry guidelines.

Our expert team provides support in the early stages of protocol development, with sample size calculation and randomization algorithms. During data collection, our team can provide interim analysis services and sample size re-estimations calculations and randomization list extensions, as well as statistical analysis planning. After data collection, we provide a full statistical programming and analysis service, together with reporting.

Every service we provide is conducted by expert biostatisticians and clinical programmers with many years of experience in clinical trials. All our processes are completed with our extensive QA/QC processes.

Thanks to the amazing collaborative strength between data managers and medical writers, biostatisticians, and clinical programmers, statistical programming and preparatory activities are conducted while data collection is ongoing. This significantly reduces timelines for statistical deliverables after database lock and export.

Ensuring regulatory compliance in statistical analysis is our priority. Rigorous validation processes, aligned with our company's high standards and industry-leading regulatory validation programs, are integral to our practices. All our statistical processes are aligned with regulatory guidelines and recommendations, including ICH E9, amongst others. Additionally our biostatisticians and statistical programmers are true scientists with PhD degrees, and perform literature reviews for state of the art procedures and continuous education.