- Data Management Consulting
Provide support in study planning to ensure the client to remain efficient and competitive. We know that data is a valuable asset and with correct planning and analysis we will be able to maximize information derived from the data.
- Data Capture Form Design & Review
Creation of forms to ensure data entry is streamlined as far as possible for both paper and EDC studies.
- Database Design, Build and Validation
The database will be built by a Programmer Team Member using the Database, Query, Roles and Schedule specifications as a source.
The validation effort is coordinated by the Data Team Lead, who writes a Validation Plan and Report, which will include pre-defined test scripts used for verification and internal and external user acceptance testing.
- Database Change Management
Database feasibility checks and maintenance, while still ensuring the database remains in a compliant and validated state.
- Data Entry & Tracking
The raw data is tracked to ensure all observations have been received and that all have been entered. Data entry for each study will be performed as per sponsor request with the general guidance of single entry with 100% QC / double entry with 100% QC of the Key datasets and 100% QC on a random 10% of the remaining datasets.
- Data Reconciliation
Laboratory data can be reconciled with the source data. Either by EDC system or manually using our analysis tools.
- Study Status Reports and Data Verification (Manual & Automated Edit Checks)
Data cleaning/review consists of the use of query checks, which could lead to queries being generated automatically in the system or manually created by the Data Team Lead. A query report consisting of a query summary and missing forms/data will be generated by the Data Team Lead and made available to the study team.
- Medical Dictionary Coding
Dictionary coding or review can be arranged for Adverse Events and Concomitant Medications (or any other dictionary available).
- Computer System Validation (CSV)
We have an experienced team performing the Computer system validation on all of our software.
For the systems used for data capturing it is critical to assure the quality of computer systems performance and compliance.