High-quality patient data is intrinsic to regulatory success and must be properly managed to ensure integrity, compliance, and safety. To minimize risk and deliver on your objectives, there is no room for error. In this highly specialized area, we concentrate on flawless execution from planning through operations. Working with our team, you can be confident that your day-to-day biostatistics and statistical programming partners are highly qualified experts with a passion for their work.
Allucent’s team of statisticians and statistical programmers will ensure your studies minimize risks to your primary and key secondary endpoints, highest quality data reporting and handling of unexpected data issues to name a few. Our statisticians and statistical programmers are dedicated to delivering quality results you can be confident in.
Every study is assigned a lead biostatistical team, consisting of a lead statistician and a lead statistical programmer. Together, these team members coordinate all aspects of your project as it relates to biostatistics and statistical programming tasks, including planning out and meticulously executing every stage of your project to ensure all your development needs are met.
An experienced statistician will lead all aspects of the statistical deliveries, from review of and contributing to the randomization interactive response technology (IRT) documentation and development of the randomization list (if applicable), writing the statistical analysis plan, developing CDISC ADaM specifications, to analyzing all levels (simple to complex) of statistical endpoints and conducting interim analyses.
Our lead biostatistical team is part of the study team at the time of the kick-off meeting through to finalization of the clinical study report and delivery of the final CDISC documentation.
Our biostatistics and statistical programming team is experienced in working within a variety of relationship models including full-service work with Allucent project management or stand-alone Biostatistics support where our lead statistician and lead programmer integrate themselves into the wider study team. We act as your primary biostatistical team to execute your clinical study. All biostatistics and statistical programming deliverables are flexible and customized towards meeting your needs. Our flexible approach for statistical and programming services is tailor-made for small to mid-sized companies. We have an experienced team, strong management oversight and involvement, a history of successful regulatory submissions, and a wide array of therapeutic experience across all study phases.
Allucent also has a wide range of experience with blinded studies, including the ability to assign an unblinded team of biostatisticians and statistical programmers to meet our sponsor’s needs, whether an unblinded live randomization list is needed or an unblinded statistician is needed for development of unblinded reports and/or attendance at a Data Monitoring Committee (DMC) meeting. Allucent has a robust process including thorough documentation for ensuring proper restricted access for maintaining the blind.
Using our strong CDISC expertise, we will set up a data mapping and analysis strategy, in close coordination with our Biostatisticians, that fits corporate, financial, and regulatory goals. We have created SDTM and ADaM-compliant datasets, including complete submission packages, for studies of all phases and complexities, including single study, ISS/ISE, historical control databases, and legacy conversions of completed studies. Our aim with CDISC programming is to create compliant data at the earliest stage possible to ensure a smooth, efficient transition to regulatory submission after database lock. Our experience includes:
- 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 capability to be your one-stop shop for set up of safety/efficacy review committees as well as delivering the blinded and unblinded data review packages. Allucent biometrics program coordinators are experienced in the following tasks:
- 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
For standalone DSMB support, Allucent’s statistical team can provide a number of services, depending on the needs of the sponsor. These services include:
- 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.