Biometrcs

Biostatistics and Data Management Unit

The Biostatistics and Data Management Unit of Effice is formed by biostatisticians specialized in biometrics and data management who accumulate extensive experience in the development of clinical trials and observational studies.

We will offer a comprehensive, individualized and personalized management of both the data management and the statistics of the research project covering all phases from the design of the study to its publication in scientific journals of international reference.

Our unit offers a great deal of experience and close collaboration in each of the phases of the project:

• 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 specialized in data management complying with Good Clinical Practice, local and international regulations, guaranteeing patient information and 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.

Electronic data collection notebook

Our eCRD is an open-source electronic data collection system that allows us to offer a fully configurable tool at a very competitive cost.

The system is validated according to a robust quality system to ensure the software performs as designed and complies with applicable regulatory guidelines including GCP and 21 CFR Part 11.

The main features of the eCRD are:

• Secure web access from any browser.
• Different options depending on the type of study. Fully customizable.
• Available in Spanish and English.
• Total guarantee of quality and safety complying with both national and international legal requirements (GCP and 21 CFR Part 11).
• Secure and personal access by roles: principal investigator, collaborating researchers, monitor and managers.
• Monitoring module: face-to-face or remote by verifying source data.
• Randomization module: randomization of patients through the platform.
• Query module: direct communication investigator/monitor.
• Signature module: the principal investigator can sign the data through the platform in compliance with current regulations.
• Data download module: system for downloading information in various formats.

Biostatistics Services

Our long experience in statistics applied to the biosanitary sector allows us to accompany the researcher from the design phase of the study to the elaboration of results, supporting him in the development of statistical methodology. Our biostatistics experts are SAS® programmers who manage all statistical activities related to projects.

Our main biostatistics services are:

• Protocol: 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.
• SAS® statistical program licensed, validated and with a great impact of use in the biosanitary field.
• Clinical Study Report (CSR) following the ICH, CONSORT for clinical trials or STROBE guidelines for observational studies.
• Creation of patient lists.
• Statistical support in 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.
• Personalized courses in content and duration both remote and face-to-face.
• Different levels of difficulty.
• Different profiles (industry, researchers, health professionals, master's degree...).