CLINICAL TRIAL DATA MANAGEMENT

  • Data management plan
  • Data cleaning
  • Medical Coding
  • SAE reconciling

ELECTRONIC DATA CAPTURE

  • EDC system with audit trail
  • Monitoring and query management
  • IWR-System
  • eSigning

STATISTICAL ANALYSIS

  • Statistical analysis plan
  • Sample size estimation
  • Statistical analysis report
  • Study report

Clinical Trial Data Management Services

Clinical Trial Planning

As a Data Management provider we offer data management and statistical analysis planning and model development with applicable CRF design. All the appropriate documentation is provided by us according to FDA and other regulations. Previous experience has shown us that putting more effort into the planning phase will give a better, faster and efficient result in the end-phase of the trial.

Data Management Plan

Statistical Analysis Plan

Annotated CRF

Clinical Trial Planning

Database Design

Our databases are generated by experienced data managers who have worked with several eCRF-s and already know the critical parts of the electronic data capture system design and data collection. This allows the eCRF to be built in a short period of time. eCRF validation and testing is compulsory part of the design and is dealt by different personnel in order to receive a hundred-percent elaborated eCRF.

eCRF Database Design

Edit Checks List

Validation Protocol

User Acceptance Testing

Database Design

Training

We provide self-guided online courses for investigators, CRA-s, depot staff and study nurses. Online courses end with a test and provide an automatic certificate of training. All the certificates and training logs are available for the study members and CRA-s for downloading. On-site personalized trainings or Skype trainings are also available if needed. Support for the users is provided by the helpdesk during the whole time of the trial.

User Manual

Training Log

Support

Training

Data Capture

Data collection is made easy by the intuitive and user-friendly Electronic Data Capture System which is used by the investigators for data entry and by the CRA-s for data review. Online data entry and monitoring allows you to get access to the monitored data during the study and generate interim reports with already collected data. The system generates automatic audit trail for data tracking and security.

Collected Data

Audit Trail

Interim Reports

Electronic Data Capture

Cleaning

Data cleaning is made easy by the automatic edit checks which trigger warnings to the users during the data insertion and monitoring. This allows you to generate urgent reports and interim analysis based on already cleaned data. For the conclusive data, the statistician and data manager will provide the final data cleaning to establish high-quality and reliable database.

Cleaning Data

Managed Queries

SAE reconciliation

Cleaning

Medical Coding

In order to have a ready-to-go database during the whole time of the study, we start coding medical terms as soon as they are registered. In order to save time, we have developed our own automatic coding system which uses approved and commonly used dictionaries such as Who-Drug and MedDRA. All the coded terms are then reviewed by the medical coder.

Coded Adverse Events

Coded Medications

Coded Medical History

Medical Coding

Statistics

The statistical analysis can be performed throughout the study, beginning with the sample size calculations, planning for the statistical analysis model and finally with statistical analysis of the whole database. Statistical analysis is related to many regulations with specific criteria and though it is important that it would be handled attentively. We are specialized in clinical research and have the resources for thorough analysis.

Sample Size estimation

Statistical Analysis Report

Final Report

Statistics

Study Locking

To give a final touch to our electronic data capture system, electronic signatures are also integrated into our system. This completes the data collection process after data cleaning and locking. After the data has been confirmed we offer cloud based data archiving and data extraction. Data extraction is done by our data managers based on the Data Management Plan, Statistical Analysis Plan and CRO/Sponsor demands.

Electronic Signatures

Extracted Data

Archived Data

Study Locking

21 CFR PART 11 COMPLIANT
AUDITED BY QC2
OVER 300 ACTIVE EDC USERS
EDC SYSTEM USED IN 7 COUNTRIES
ECRF, IWRS, CODING AND DEVELOPMENT OF NEW SOFTWARE