Adaptive plus

Adaptive Plus: Your Trusted Partner in Biostatistics Consulting

Adaptive Plus is a leading biostatistics consulting firm that specializes in adaptive trial designs and group-sequential designs. With years of clinical experience, our team of expert statisticians has worked on 24 adaptive trial designs and 12 group-sequential designs to date.

At Adaptive Plus, we understand the importance of designing efficient and effective clinical trials. Our goal is to help our clients optimize their study design, reduce costs, and accelerate drug development timelines. We work closely with our clients to develop customized solutions that meet their specific needs.

Our Services

Adaptive Trial Designs

We specialize in adaptive trial designs that allow for modifications during the course of a study based on interim data analysis. This approach can lead to more efficient trials by reducing sample sizes, shortening timelines, and increasing the probability of success.

Group-Sequential Designs

We also offer expertise in group-sequential designs which allow for interim analyses at pre-specified time points during a study. This approach can help identify early efficacy or futility signals while maintaining statistical rigor.

Sample Size Calculations

Determining an appropriate sample size is critical for any clinical trial. Our team uses advanced statistical methods to calculate sample sizes based on desired power levels, effect sizes, and other relevant factors.

Statistical Analysis Plans

We work with our clients to develop comprehensive statistical analysis plans (SAPs) that outline the methods used for data analysis. This includes specifying primary and secondary endpoints as well as handling missing data or outliers.

Data Monitoring Committees

We provide support for Data Monitoring Committees (DMCs) which are independent groups responsible for reviewing interim safety or efficacy data during a clinical trial. Our team can assist with DMC charter development as well as providing ongoing support throughout the study.

Regulatory Submissions

Our team has extensive experience preparing regulatory submissions including Clinical Study Reports (CSRs), Integrated Summaries of Safety and Efficacy (ISS/ISE), and New Drug Applications (NDAs).

Why Choose Adaptive Plus?

Expertise

Our team of statisticians has extensive experience in adaptive trial designs, group-sequential designs, and other advanced statistical methods. We stay up-to-date with the latest developments in the field to ensure our clients receive the most innovative solutions.

Customized Solutions

We work closely with our clients to develop customized solutions that meet their specific needs. We understand that every study is unique and requires a tailored approach.

Efficiency

Our adaptive trial designs can lead to more efficient trials by reducing sample sizes, shortening timelines, and increasing the probability of success. This can result in significant cost savings for our clients.

Regulatory Compliance

We have a deep understanding of regulatory requirements for clinical trials and ensure that all of our solutions are compliant with relevant guidelines.

Conclusion

Adaptive Plus is your trusted partner for biostatistics consulting services. Our team has extensive experience in adaptive trial designs, group-sequential designs, sample size calculations, statistical analysis plans, data monitoring committees, and regulatory submissions. We work closely with our clients to develop customized solutions that meet their specific needs while ensuring compliance with regulatory requirements. Contact us today to learn how we can help optimize your clinical trial design and accelerate drug development timelines.