RioConsulting
Clinical research organization providing clinical trial support, clinical data management, biostatistics, statistical programming, medical writing, regulatory support, and staffing/FSP solutions for pharmaceutical, biotechnology, and medical device clients. Services cover clinical phases I–IV, e-submission preparation, and data science staffing.
Industries
Nr. of Employees
small (1-50)
Products
Clinical Trial Management
Management of clinical trials from phase I to IV, including post-market analysis, both on-site and off-site.
Data Management
Services include data management plan creation, database development, data entry and cleaning, and database lock.
Biostatistics and Programming
Offers statistical analysis plans, power/sample size estimation, and programming support for clinical trials.
Biostatistics and Statistical Programming
Offers biostatistics services like clinical trial development plans and statistical analysis, along with programming support for data mapping and regulatory submissions.
Medical Writing
Creation of clinical study reports, protocols, and informed consent forms, along with publication support.
Regulatory Support
Provides global regulatory strategies and support for all phases of clinical development, including CMC and labeling.
Clinical Trial Management
Management of clinical trials from phase I to IV, including post-market analysis, both on-site and off-site.
Data Management
Services include data management plan creation, database development, data entry and cleaning, and database lock.
Biostatistics and Programming
Offers statistical analysis plans, power/sample size estimation, and programming support for clinical trials.
Biostatistics and Statistical Programming
Offers biostatistics services like clinical trial development plans and statistical analysis, along with programming support for data mapping and regulatory submissions.
Medical Writing
Creation of clinical study reports, protocols, and informed consent forms, along with publication support.
Regulatory Support
Provides global regulatory strategies and support for all phases of clinical development, including CMC and labeling.
Services
On-site and off-site support for clinical trials including operational, data, statistical, and regulatory services across study phases.
Data management plan creation, database development and locking, data cleaning, SAE reconciliation, dictionary coding, and EDC training/support.
Statistical analysis planning, sample size estimation, interim and final analyses, SDTM/ADaM development, TFL generation, and submission package preparation.
Preparation of protocols, CSRs, safety narratives, CTD summaries, informed consent forms, agency briefing packages, and publication materials.
Global regulatory strategies and support for IND/CTA filings, import/export documentation, CMC coordination, labeling, and translations.
Contract, direct-hire, and function service provider (FSP) engagement models to supply statistical programmers, biostatisticians, data managers, and medical writers.
On-site and off-site support for clinical trials including operational, data, statistical, and regulatory services across study phases.
Data management plan creation, database development and locking, data cleaning, SAE reconciliation, dictionary coding, and EDC training/support.
Statistical analysis planning, sample size estimation, interim and final analyses, SDTM/ADaM development, TFL generation, and submission package preparation.
Preparation of protocols, CSRs, safety narratives, CTD summaries, informed consent forms, agency briefing packages, and publication materials.
Global regulatory strategies and support for IND/CTA filings, import/export documentation, CMC coordination, labeling, and translations.
Contract, direct-hire, and function service provider (FSP) engagement models to supply statistical programmers, biostatisticians, data managers, and medical writers.
Expertise Areas
- Clinical trial management
- Clinical data management
- Biostatistics and statistical analysis planning
- Statistical programming and CDISC implementation
Key Technologies
- Statistical programming languages and environments
- Electronic data capture (EDC) systems
- CDISC standards (SDTM, ADaM)
- e-submission formats and XPT datasets