We provide solutions for both one-off services and integrated projects
Statistical and methodological consultancy
Our lengthy experience allows us to advise our clients both in the study design phase and during development or the interpretation of results. At all times from a methodological or statistical perspective
- Study design, calculation of the sample size, interpretation of results, scientific articles, regulatory aspects.
- Occasionally or during the project.
- Attendance at meetings.
Project Management
We will provide comprehensive management.
- Design of the study
- Authoring of the protocol
- Administrative procedures and approvals
- Electronic data capturing system
- Monitoring in-person or remotely
- Support for researchers
- Monitoring reports
- Payment management
- Data management
- Statistics
- Final Report
- Scientific articles with expert medical authors
Official paperwork
Extensive experience in the management of all regulatory and administrative aspects of the studies.
- • Regulatory authorities and Ethics Committees
- Contract management
- Payment management
Biometrics and statistics
Experts in global data management, using either electronic or hard-copy data capture. Experts in biostatistics and SAS programmers managing all statistical activities connected with the projects.
- Data Management Plan
- Comprehensive data management (review, coding, queries…)
- Electronic Case Record Form
- Authoring of the protocol statistics section
- Calculation of the sample size
- Statistical Analysis Plan (SAP)
- Statistical analysis of pre-clinical data, bioequivalence, clinical trials, epidemiological studies…
Training
Tailored courses.
- Courses with customised content and duration
- Different levels of difficulty
- Different profiles (industry, researchers, healthcare professionals, etc.)
Electronic Data Capture
We work with OpenClínica, an open source electronic data gathering system allowing us to offer a powerful tool at a highly competitive cost. We offer different options depending on the type of study. Validated system.
- Available in Spanish and English
- Total guarantee of quality and security, as it complies with all national and international regulatory requirements
- Different access permissions: data entry assistant, principal investigator, monitor, etc.
- Monitoring module (in-person or remote)
- Random assignment system
- Information downloading system
