Apices can provide answers to pressing research questions in the areas of medicine, biology and public health. Our Biostatistics team offers support and expertise for all aspects of clinical studies and works to pre-determined timelines.
Apices’ biostatistics services include, but are not limited to: protocol writing, statistical analysis plans (SAPs), code programming and validation, sample size calculations, tables, listings and figures (TLFs), and statistical analysis reports. Our biostatisticians are trained in the use of CDISC Analysis Data Model (ADaM), which allows analysis results to be generated, replicated and reviewed efficiently.
Apices’ experienced biostatistics team works designing and executing programs that allow data to be reported, displayed, and captured effectively. Our analytical solutions comply with regulatory requirements and are designed to ensure trials are carried out successfully.
Data Management Services
APICES’ data management services are tailored to provide the most flexible, cost-effective service for your clinical trial needs. Our planning and resources ensure quality of data; this is our main objective for clinical data management, always complying with timelines and budget.
Among our data management services are the following:
- Designing, validating and releasing databases
- Data management and validation plans
- Programming edit checks
- Interactive web response systems (IWRS) for randomisation and patient enrolment
- Generating listings and blind codes for randomised studies
- Designing case report forms (CRFs)
- Programming and managing electronic case report forms
- Coding according to international dictionaries eg. MedDRA, WHO Drug
- Double data entries for paper-based CRFs and questionnaires
- Data review meetings
- Database reconciliations
- Preparing databases for regulatory filings
Our clinical data management professionals aim to ensure the highest quality of data during implementation while meeting sponsors’ needs and complying with Clinical Data Interchange Standards Consortium (CDISC) recommendations.
APICES enables communication with our database to increase customers’ control over clinical data. We can also arrange Data Review Meetings with the customer if these are deemed helpful.
Our Electronic Data Capture and Data Management Systems are fully validated and certified according to FDA 21 CFR Part 11, EMA/INS/GCP/454280/2010 and ICH-GCP specifications. These validations provide objective documented evidence that the system/application runs accurately, reliably and produces reproducible data, as well as functions in line with predetermined specifications.