Overview

PharmaVigilant works with highly experienced Data Managers to provide a fully integrated data management solution. We can provide all activities or just a subset.

CRF Design

Data Managers take complete protocols and design the annotated CRFs and edit checks for the studies. Our usual time for this process is 1-2 weeks with one round of review. Our CRF designs take full advantage of the robust capabilities within InSpire and can be designed to meet the SDTM or CDASH requirements.

CRF Completion Guidelines

Data Managers develop CRF completion guidelines that are attached to a help link for each page.

Data Management Plan

Data Managers develop and maintain Data Management Plans for each study. The Data Management Plan is approved by the Sponsor.

Coding

Data Managers complete the coding for AE's, Con Meds and Med History. PharmaVigilant's system AutoCodes the AE's and they can be modified by the Data Manager. We use a knowledge base so that the same coding choices can be transferred from one study to another.

CDASH/CDISC SDTM

Our Data Managers can design our eCRFs to meet the requirements for CDASH or CDISC SDTM standards.

Data Cleaning and Data Lock

Data Managers will do continuous cleaning of the data with the goal of locking subjects efficiently so data lock can occur rapidly (approximately 1 week) after last monitoring visit.

Quality Assurance

Data Managers perform QA of the database and the results are provided to the sponsor.