Analytical Support for non-clinical and clinical datasets
Data generated from clinical trials are at the heart of drug development. Even a potentially life saving drug will fail in a poorly designed study if the data collected is not properly collected, validated and analyzed. Engaging early and often with an expert biostatistics consulting team can help you make smarter decisions over the duration of your program and reduce the risk of conducting studies that produce unreliable, poor quality data yielding unintepretable results.
Certara’s global team of biostatisticians and statistical programmers offer comprehensive support services for preclincal data and in all phases of drug development. Our expertise culminates from a deep understanding of data, study design and regulatory requirements. Consequently, we also support post-approval regulatory commitments, regulatory responses for statistical questions, regulatory briefing book preparation, and face-to-face regulatory meetings. In addition, the team has extensive experience with medical experts as well as key opinion leaders for publication support. By working with Certara biostatisticians, you can help ensure that your clinical trials are conducted in most efficient and cost-effective way and maximize the chances for regulatory approval.
Biostatistics Consulting and Analysis
Our highly experienced team of biostatisticians have extensive experience supporting all phases of drug development and offer a wide range of services, including:
- Statistical input to Clinical Development Plan (CDP), Target Product Profile (TPP)
- Study design including power and sample size calculations, as well as the statistical section of protocol
- Study design including power and sample size calculations, as well as the statistical section of protocol
- Adaptive Statistical Methods, including Bayesian Analysis
- Development of Statistical Analysis Plan (SAP) and Table, Listing, and Figure (TLF) shells
- Clinical Study Report authoring & review
- Data Monitoring Committee and Data Safety Monitoring Boards (DMC/DSMB) support
- Independent Statistical Data Analysis Center (iSDAC): DMC Charter, SAP development/authoring, blinded/unblinded DMC report production
- Secure Data Office (SDO): hub for the control of unblinding data streams
- Regulatory support including
- ISS/ISE/ISI production
- Submission consulting, including support for Health Authorities requests
- FDA advisory committee panel support
- Statistical representation for FDA or global regulatory meetings including briefing books
CDISC-Compliant Statistical Programming Services for SDTM and ADaM Datasets
Our highly experienced statistical programming team has supported all phases of drug development and provides the following services:
- Data Transfer from all parties: Sponsor, CROs, central labs, etc.
- SDTM Dataset programming
- ADaM Dataset programming
- TLF programming
- Review of data for consistency and scientific integrity
- Support for DSMB/DMC outputs
- Submission-ready data delivery including SDTM & ADaM Define.XML, Reviewers’ Guides and Pinnacle 21E checks
Clinical Data Management and Oversight to Ensure Success and Accuracy throughout your Trial
Certara’s clinical data management and oversight services include:
- Manage vendor used for electronic case report form (eCRF) build and data management
- Contribute to eCRF design & development
- Perform User Acceptance Testing to ensure that the Electronic Data Capture (EDC) system fulfils the requirements for a clinical study
- Review of data management documents, e.g., Data Management Plan, Data Validation Manual, eCRF completion guidelines, edit check specifications
SEND Dataset Programming Services for Non-Clinical Data
Certara’s biostatistical programming team offers preparation of submission-ready, CDISC compliant SEND dataset packages. Flexible delivery timelines are available for SEND dataset packages and supporting documentation required to support SEND FDA IND and IND submissions, as well as legacy SEND conversion projects.
- Generate SEND dataset packages using SAS programming
- Run validation through Pinnacle 21 software to ensure submission compliance
- QC review of SEND datasets for all studies and review work by third-party organizations like CROs to ensure data integrity and submission quality
Ragini is a Senior Director of Biostatistics at Certara. She has 20+ years’ experience in the fields of statistical programming, biometrics and data management in the pharmaceutical industry. She’s led multiple complex submissions to the FDA, EMEA and PMDA, and has demonstrated expertise in CDISC and regulatory submissions throughout her career. Prior to joining Certara, she held various leadership positions at Cytel, ICON, PPD and Covance. Ragini also serves as the Co-Vice Chair for Women in Bio.
Thomas E. Peppard has a Master’s degree in Statistics and over two decades of expertise in Phase 1-3 pharmaceutical research. Currently serving as a Senior Director of Biostatistics at Certara, Tom develops and executes statistical analysis plans, advises on clinical trial design and simulation, and consults on data-driven decision-making for pharmaceutical and biotechnology clients globally. Tom has experience across a range of therapy areas including infectious disease, maternal and neonatal health, cardiovascular disease, pulmonary disease and inflammatory disease, and he has experience across a range of trial designs and analyses including bioequivalence, crossover, non-inferiority and cluster randomized designs. Tom is a certified Advanced Programmer in SAS and is a proficient R programmer, including R/tidyverse.