ADVANCED STATISTICAL INSIGHT & PROGRAMMING PRECISION

Boost your Study with Expert Support from Design to Submission

  • NComprehensive statistical support
  • NSystematic literature review and sample size calculations
  • NBiostatistical rescue
  • NDeep medical expertise
Advanced Statistical Insight & Programming Precision

Boost your Study with Expert Support from Design to Submission

  • NComprehensive statistical support
  • NSystematic literature review and sample size calculations
  • NBiostatistical rescue
  • NDeep medical expertise

Drive trial success with our biostatistics and statistical programming services

Before the study begins, we utilize biostatistical methods to oversee the study design, including calculating the sample size. Our team also provides randomization solutions to ensure a scientifically sound performance. As the data collection is complete and clinical study brought to a close, our biostatistics provide a quantitative framework for interpreting the study results. It becomes the critical lens through which the success or nuances of the clinical study are revealed.

Guide the clinical study through meticulous design to conclusive analysis selecting a proficient team with expertise in statistical nuances and programming finesse.

Main areas of biostatistics and statistical programming

Unlock the potential of our service offerings

Wemedoo biostatistics and statistical programming services apply comprehensive statistical principles and methods throughout the clinical trial continuum. Our rigorous trial design, including sample size calculations and randomization schemes, is complemented by thorough statistical analysis planning, programming, and reporting. Through in-house statistical quality control, we ensure precision and quality at every stage of clinical research journey. Our expert team, comprised of PhD level biostatisticians with deep medical backgrounds, will help navigate every of clinical trials from protocol development, hypothesis generation, statistical analysis plan writing, through to the final statistical analysis report. All deliverables adhere to international guidelines and regulatory standards, reflecting our commitment to producing robust, reproducible and compliant outcomes in clinical research.

Sample size calculation

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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.

Adaptive trial design

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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.

Final statistical analyses and TFL generation

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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.

Reporting

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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.

Randomization

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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.

Interim statistical analyses

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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

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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.

Compliance with regulatory standards

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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.

Sample size calculation

:
;

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.

Adaptive trial design

:
;

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.

Final statistical analyses and TFL generation

:
;

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.

Reporting

:
;

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.

Randomization

:
;

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.

Interim statistical analyses

:
;

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

:
;

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.

Compliance with regulatory standards

:
;

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.

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Benefits of our service

Exploit the perks of our clinical biostatistics and statistical programming services

The integration of seasoned biostatisticians, advanced clinical programming, clinical data management, and collaborative medical writing at Wemedoo translates into significant benefits for our clients. With our statistical and medical expertise, our biostatisticians industry-leading protocol design support and analysis, while minimizing risks and optimizing outcomes. We couple expertise in leading statistical programming software and data representation with CDISC regulatory requirements to ensure the best possible outcomes. This harmonious collaboration yields precise and compliant clinical study results – benefiting our clients with reliable insights, expedited timelines, and a competitive edge in the clinical research landscape.
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Frequently asked questions

Get the answers you need about our biostatistics and statistical programming service

At what stage of a clinical study does Wemedoo provide biostatistical services?

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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.

How does Wemedoo ensure reliability of study results?

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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.

How long does statistical analysis take after data collection is complete?

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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.

How does Wemedoo ensure regulatory compliance of statistical analysis results?

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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.

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Explore related services

Discover comprehensive solutions for your clinical trial needs

Beyond professional biostatistics and statistical programming, Wemedoo offers a comprehensive suite of integrated data operations services for clinical trials. At each step we ensure your trial meets the highest quality and regulatory standards, while streamlining your clinical trial processes, and saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.
Protocol Development
Clinical Data Management
Risk-Based Monitoring and Source Data Review
eTMF Setup and Administration
CDISC-Compliant Dataset Generation
Medical Writing and Documentation
Our certifications
We are ISO 9001 and ISO 27001 certified. Our commitment to robust information security and superior quality management is at the core of our innovative solutions, ensuring reliable and efficient trial management for our clients.

What our clients say

Read more about the experiences from those who have partnered with us

"All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team."

Georg Mathis, PhD

CEO Appeltree CI Group AG

"Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail."
Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

"Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Considering unified clinical trial software?

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