Data Management

Data management

A-Pharma offers you a full range of the data management services for the pharmaceuticals industries, across many therapeutic areas. Our data management services are tailored to fit your clinical trials needs. We use easy, self-explanatory and integrated online platform for the EDC, CTM and CDM. The system works in a single, central, online CDISC ODM fully validated database and corresponds to all regulatory requirements (GCP, 21 CFR 11, Data Protection Act).

Offered services:

Design/Review of Protocol
Case Report Form (CRF) design and/or review – paper CRF/ eCRF
Randomization procedures
Database Administration

+ Design and construction

+ Testing

+ Validation

+ Maintenance

+ Full audit trial

+ Technical support

Data Entry:

Automated/consistency checks
100% Source Data Verification (SDV)
Double Data Entry (DDE)
Electronic Data Capture (EDC)
Coding

+ MedDRA coding for the Medical History, Adverse Event (AE)

+ ATC coding for the Ongoing and Concomitant Medication

Data Validation/Verification:

Automated query generation
Database cleaning
Study status reports
Data Transfer and Processing

Statistical procedures:

SAS
Statistical analysis plans (SAP)
Final Data Listings
Blind review meeting
Final Statistical Report

A-Pharma uses the XClinical´s own EDC solution: MARVIN. Our data managers are well- trained and experienced in the system. We always discuss with the sponsor what is the best solution for the study- depending on the timelines, the size of the CRF, number of countries and languages involved, and most importantly, number of subjects- whether a paper based or the electronic process has more benefits to guarantee successful conduct of the trial. Our goal is to ensure smooth and successful run of the trial for all trial participants, such as investigators, project managers, monitors, data managers, medical advisors, sponsor representatives etc.