Biostatistics solutions that ensure data integrity, minimize risk, and achieve regulatory success
High-quality patient data is essential to regulatory success and must be expertly managed to ensure integrity, compliance, and patient safety. With no room for error, minimizing risk and meeting your objectives requires deep expertise and precision. This is where our biostatistics CRO services provide value, offering flawless execution from planning through operations. When you partner with us, you gain a team of highly qualified biostatistics and statistical programming professionals who are deeply committed to delivering with excellence every step of the way.
Expertise in Biostatistics and Statistical Programming
Allucent’s team of statisticians and statistical programmers deliver trusted solutions for clinical research, helping to ensure the success of your studies from start to finish. Our team helps:
- Ensure your studies minimize risks to your primary and key secondary endpoints
- Provide the highest quality data reporting
- Effectively handle any unexpected data issues, and more.
Our statisticians and statistical programmers are dedicated to delivering quality results you can be confident in through comprehensive biostatistics solutions tailored to your unique program needs.
Study Execution
Every study is assigned a lead biostatistical team, consisting of a lead statistician and a lead statistical programmer. As part of our clinical biostatistics services, these team members coordinate all aspects of your project related to biostatistics and statistical programming, including planning and meticulously executing each stage of your project to ensure all your development needs are met. This lead team remains an integral part of the study team from the initial kick-off meeting through to the final clinical study report and delivery of the final CDISC documentation.
Flexible Engagement Models
As a biostatistics CRO, our biostatistics and statistical programming team brings extensive experience working within a variety of relationship models. This includes full-service collaborations with Allucent project management or flexible biostatistics outsourcing solutions, providing stand-alone biostatistics support where our lead statistician and lead programmer integrate seamlessly into the wider study team. We serve as your primary biostatistical partner to execute your clinical study with precision and expertise.
Allucent’s biostatistics CRO solutions are flexible and customized to meet your specific needs. Our adaptable approach is tailor-made for small to mid-sized companies, supported by a highly experienced team, strong management oversight, a track record of successful regulatory submissions, and broad therapeutic experience across all study phases.
“Our team provides high-quality data and analysis support, helping to get medications to market quicker to treat patient populations in need.”
Anna Burkhardt
Vice President, Biostatistics and Statistical Programming
CDISC Programming Excellence
Leveraging our strong CDISC expertise, Allucent’s statistical programmers will set up a data mapping and analysis strategy in close coordination with our biostatisticians, ensuring alignment with corporate, financial, and regulatory goals. Our experience with biostatistics in clinical trials ensures that this strategy supports both scientific integrity and submission readiness.
We have created SDTM and ADaM-compliant datasets, including complete submission packages, for studies of all phases and complexities—ranging from single studies to ISS/ISE, historical control databases, and legacy conversions of completed studies.
Our aim with CDISC programming is to create compliant data as early as possible to ensure a smooth and efficient transition to regulatory submission after database lock.
Our Comprehensive CDISC Capabilites
- CDISC legacy conversion
- BIMO package
- CDISC-compliant Gap analyses
- Non-traditional submissions
- Fully compliant CDISC packages, including aCRF files for SDTM and Define.xml files for SDTM and ADaM
- Reviewer’s guides in multiple formats (e.g., PHUSE standard), including validation confirmation and Pinnacle 21 notes
- Study program guides that provide details on how programs and macros are used to create the SDTM and ADaM domains
Data Safety and Monitoring Board (DSMB)/Data Monitoring Committee (DMC) Standalone
Allucent has the expertise to be your one-stop shop for the set up of safety/efficacy review committees as well as for delivering the blinded and unblinded data review packages.
Our Biometrics Program Coordinators’ Expertise For DSMB/DMC Support
- Initiating and finalizing CDAs with identified members
- Initiating and finalizing member contracts
- Organizing meetings
- Developing agendas
- Managing restricted sites
- Overseeing charter development (along with the lead statistician)
- Drafting and finalizing meeting minutes
Allucent’s Services for Standalone DSMB/DMC
- Development and review of the charter
- Development of the DSMB Statistical Analysis Plan and corresponding TLF shells. This plan may include any interim analyses to be reviewed by the DSMB.
- Assigning blinded and unblinded statisticians (non-voting) and statistical programmers, as required by the charter.
- Providing Open and/or Closed session TLF materials to be reviewed by the DSMB. For Closed sessions, materials will be provided by the unblinded statistician, who may facilitate the presentation of TLFs to the DSMB.
