Biometrcs

Biostatistics and Data Management Unit

Our Biostatistics and Data Management Unit comprises biostatisticians and data managers who have accumulated extensive experience in the development of clinical trials and observational studies.

We offer a comprehensive and personalized management of both the data management and the statistics from study design to publication in scientific journals.

The biometrics team can support with:

• Statistical wording of the protocol.
• Data Management Plan.
• Electronic data capture system (OpenClinica).
• Monitoring reports.
• Data management in compliance with all legal requirements.
• Statistical analysis plan.
• Advanced statistics.
• Final report of results. Clinical Study Report.
• Statistical support in medical publication and peer review.

Data management

Our team is trained in Good Clinical Practice and local and international regulations, ensuring patient data confidentiality at all times.

Our main data management services are:

• Consulting and protocol design.
• Preparation of all documents associated with data management: Data Management Plan (DMP), Query Plan (QP), Case Report Form (CRF).
• Database creation and validation.
• Data entry and review services.
• Data completeness reports with the desired frequency.
• Management of inconsistencies and queries through the platform.
• Medical coding.
• Reconciliation of adverse events.
• Database shutdown and quality control.
• Generation of final datasets for analysis in various formats.

eClinical Technology Suite

We have different technology options depending on study needs and budget.

We offer:

1. Visualization – a window into comprehensive study progress and patient data
2. EDC – simple interface; drag and drop configuration; automated data integration and processing; IMP randomization directly within the eCRF
3. ePRO, eCOA - possibility for patients to directly report data, involving electronic devices such as smartphones, tablets, or web-based platforms; collection and documentation of clinical outcome assessments from patients, physicians or nurses.
4. CTMS - Customized dashboard per user role; standard study templates and logs; key performance indicator (KPI) reports; monitoring visit tracking; timeline and milestone tracking; contract management; budget and payment management
5. RTSM - lifecycle coverage for trial supply kit shipment and current status; randomization; allocation and accountability; export of end-of-trial randomization report.
6. eTMF - Insights through real-time reports; rapid startup timeline; exportable to fully validated eArchive; convenient document management.
7. eConsent - enables study participants to register for a trial using electronic devices and submit their consent.
8. Medical Devices - Support for various connected devices and wearables enabling direct data collection for comprehensive trial insights.
    

Biostatistics Services

Our long-standing experience in statistics within healthcare allows us to accompany the researcher from the design phase with the appropriate statistical methodology to the publishing of results. Our biostatistics experts are also SAS® programmers who manage all statistical activities related to projects.

Our main biostatistics services are:

• Development of the statistical sections of the protocol

• Calculation of sample size (N) including statistical justification

• Statistical Analysis Plan (SAP)

• Creation of patient randomization lists according to protocol requirements

• Data analysis meeting the highest quality standards

• Validated SAS® statistical programming environment

• Clinical Study Report (CSR) following the ICH, CONSORT for clinical trials or STROBE guidelines for observational studies

• Creation of patient lists

• Statistical support for scientific articles including peer review

Statistical training

We carry out numerous training programs with the aim of training researchers in statistics applied to research and publication of results.

• Tailor-made courses in terms of content and duration - both remote and face-to-face.
• Different levels of difficulty.
• Designed for different profiles (industry, researchers, health professionals, master's degree...)