We provide full-service solutions for Phase I-IV clinical research and medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas: oncology, CNS, cardiovascular, infectious disease, immunology, rheumatology, pulmonology, endocrinology, gynecology, gastroenterology, nephrology, ophthalmology, urology and dermatology.
EDC, Data Management and Biostatistics
Our Data Management team provides high-quality collection, organization, validation, analysis, and quality control of clinical trial data. Generally we utilize electronic data capture (EDC) to expedite data collection and enhance quality, but we can also handle paper CRFs (including printing, despatch, collection and double data entry). Services include:
- CRF Design, Edit Checks and Validation;
- Data Management Plan;
- EDC User Acceptance Testing;
- EDC eLearning and Helpdesk;
- Data Entry (for paper CRF or eDiary);
- Data Cleaning;
- SAE Reconciliation;
- Production of Listing for Medical Review;
- Medical Coding;
- Metrics/Tracking Report;
- External Data Load (e.g. labs);
- Database Lock;
- Database Transfer;
- Patient Data Reports.
Biomapas skilled biostatisticians provide trial design consultation, statistical methodology recommendations, statistical programming and analysis to create a customized approach designed specifically to meet individual project requirements. Services include:
- Protocol and Statistical Analysis Plan development;
- Comprehensive data analysis plans including sample size determinations and power calculations;
- Detailed descriptions of statistical methodologies;
- Interpretation of study results and writing support for the preparation of interim analyses and study reports;
- Preparation of tables, listings and graphs including SDTM and ADaM compliant datasets;
- Integrated efficacy and safety analysis for regulatory submissions.
For any inquiry regarding our services, please contact Biomapas Business Development team.