Our Biostatisticians and statistical Programmers deliver accurate, High-quality, and timely Biostatistics Services.
Our biostatisticians bring extensive experience of biostatistics services, from first-in-man to Phase IV trials, across a broad range of therapeutic areas
Statistical Programming team collaborates with the Medical Writing group to ensure proper interpretation of study results. Biostatistics is involved in every step of clinical research services like clinical trial design, protocol development, sample size determination, study endpoints, data management, data monitoring, data analysis, and clinical trial reporting
Our Biostatistics Services include:
- Designing Statistical analysis plan (SAP),
- Coordinating and managing DSMB outputs and meetings
- Interim Analysis/Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support, PK / PD analysis, and advice for Interim Analyses and DSMBs.
- Provision of Clinical Data Interchange Standards Consortium (CDISC): SDTM and ADaM compliant analysis datasets
- SDTM (Study Data Tabulation Model) datasets.
- ADaM (Analysis Data Model) datasets.
- Randomization /Unblinding support.
- Validation of datasets via Independent double programming.
- Blinded and Unblinded TFLs (Tables, Figures, and Listings).
- Preparing Statistical Report / Clinical Study Report – our statistical and medical writing teams collaborate to produce high-quality reports.
- Submission ready datasets which are consistent with industry standards.
- ISS/ISE- we provide support for the integration of safety and efficacy data before regulatory approval.
ICBio leverages high-quality, cost-effective solutions to ensure successful management and delivery of clinical trial data. Our primary goal in data management is to provide clean, locked databases in an optimal format, on time, and to budget.
To achieve this, we offer leading industry tools for data management, like Medidata RAVE® or VEDOC® for eCRFs, and Statistical analysis – SAS 9.1.3 Validated Software providing a tailored approach to suit every client’s needs, budget, and clinical site logistics.
Our Services can be customized to deliver a high-quality, cost-effective solution compliant with the most rigorous regulatory standards.