ClinBAY
 | |
| | |
| ClinBAY ltd | |
|---|---|
| Type | Private |
| Industry | Contract Research Organization |
| Founded | 2007 |
| Slogan | Statistical Solutions to Drug Development |
ClinBAY is a Biometrics Clinical Research Organisation (CRO), founded in 2007 that provides statistical consulting and programming in clinical trials[1].
Clinbay helps design and report approximately 40 tailored clinical trials per year, as well as a solid information package to report study results, registration dossiers, write publications or prepare interactions with investors.
They have experience in all phases of research and development, spanning from preclinical analysis to clinical and post-marketing support across a wide range of therapeutic areas (oncology, neurosciences, dermatology, ophthalmology, Respiratory, etc).
Contents
History
ClinBAY was founded in Belgium in 2007, as a spin-out of a major pharmaceutical company. Since then, ClinBay has established itself as a reliable biometrics CRO.
In 2007, ClinBAY began to offer novel and Bayesian methods for clinical trials. ClinBAY released Decimaker in 2008: a software for the design and analysis of Bayesian adaptive dose-finding trials.
Shortly after in 2009, a SAS and R-programming unit was established. Analysis and reporting of clinical trials were also offered.
In 2010 ClinBAY released ClinXPORT: an automated software to streamline the analysis and reporting of clinical trials.
ClinBAY opened its second office in Cyprus in 2012. Which is now the head office.
Analysis and Reporting capabilities expanded to manage more than 30 trials of all phases and kind per year in 2014.
In 2016, functional sourcing of statistical and programming consultants were made available to it’s clients. Medical affairs support was also initiated.
ClinBAY celebrated its 10th anniversary in 2017 and the development of custom R packages.
In 2018, the new headquarter office in Limassol, Cyprus was officially established providing full biometrics support, including DM, scientific writing and PK/PD.[2].
Despite the 2020 COVID-19 pandemic, ClinBAY has, since its inception, given its employees the flexibility of teleworking and therefore ClinBAY’s work and project deliveries were not affected by the pandemic.
ClinBAY team
ClinBAY’s team of over 20 staff includes statistical and programming consultants with more than 10 years clinical trial experience. Educated at PhD-level and master-level statisticians, software developers, who maintain the IT infrastructure and develop custom software tools for ClinBAY’s services; a business development manager, a QA expert, and an administrative manager.
Services
Statistical Consulting [3].
- Statistical support for a streamlined clinical development plan
- Optimal design of each study protocol
- Regulatory strategy for Biostats
- Novel statistical methodologies for the design and analysis of clinical data
- Safety monitoring
- Collaboration with your clinical and regulatory groups
- Quality and project management
Statistical Analysis and Reporting [4]
- Interim Analyses
- Clinical study reports (CSR)
- SAS® and R Programming
- Development of Statistical Analysis plan (SAP) and Mock Table, Figures and Listings (TFLs)
- Generation of analysis datasets
- CDISC format deliverables (mapping to SDTM and ADAM)
- Development of CDISC documentation (Pinnacle 21 validation report)
- Production of TFLs
- Data and Safety Monitoring Board (DSMB)
- Independent Data Monitoring Committees (IDMCs)
- Submission to regulatory authorities
- Integrated analysis (ISS, ISE)
- Abstract and Publication support
Products
- Datasly: Datasly is a data visualization tool for SAS®, CSV, Excel® data formats to easily filter, search, group, re-order, export to Excel, plot, and compute statistics on data tables [5]
- ClinLogViewer: ClinLogViewer is a free syntax-coloured viewer for SAS® log files, including other features, as extracting a SAS® program from a SAS® log. [6]
- ClinMacroDoc: ClinMacroDoc is a tool that can automatically create SAS® macro library documentation directly from the SAS® macro code. It outputs a simple yet detailed document listing all the macros, their input parameters, etc, which can be kept up to date without user intervention. [7]
- ClinXPORT: ClinXPORT is tool which streamlines the statistical analysis and the reporting of clinical trials with SAS®. With ClinXPORT you can design table shells in Excel and generate the corresponding SAS® code in less than 30 seconds. (only available with ClinBAY’s Services package). [8]
References
- ↑ https://www.clinbay.com/about/history
- ↑ https://www.clinbay.com/about/history
- ↑ https://www.clinbay.com/services/statistical-consulting
- ↑ https://www.clinbay.com/services/analysis-and-reporting
- ↑ https://www.clinbay.com/products/datasly/datasly-sas-data-visualisation-tool
- ↑ https://www.clinbay.com/products/sas-log-viewer
- ↑ https://www.clinbay.com/products/sas-macro-package-documentation-creator
- ↑ https://www.clinbay.com/products/clinxport
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