Data Management Services

Expert Clinical Data Management Services for Your Clinical Trials

Effective clinical data management services are critical to ensure efficient access, processing, summarization, and dissemination of clinical study data and information. At iuvo, our data management services incorporate leading-edge technology, 21 CFR Part 11 compliant systems, and experienced clinical data management personnel to support both electronic clinical data capture (EDC) and traditional Case Report Form (CRF) double data-entry applications.

Our extensive data management services are scalable to your needs and emphasize well-organized, appropriately documented, accurate and timely processing of your clinical data.

Case Report Form (CRF) Design 
Using the study protocol, iuvo’s Clinical Data Management Team prepares and formats data collection forms indicating study data fields to be collected and, where appropriate, allowable responses for each field. CRFs are designed in a simple, user-friendly manner to help minimize entry errors. Each study CRF ais formally reviewed by the client prior to implementation.

Clinical Data Management Plan
Based upon the approved CRF, iuvo develops detailed database design specifications (DDS) for our client’s clinical study database – including name, event name, event structure, data field definitions, code-list and automated edit checks. iuvo team members then prepare the written data management plan, which includes CRFs, annotated CRF, Group and User Set-Up Request Forms (for EDC study), Risk Analysis assessment, Database Development Checklist, Database Validation Plan, User Acceptance Test Plan, Data Processing Guideline, In-House CRF Review Guideline, Data Cleaning Guideline, Validation Report, User Acceptance Test Report and Database Lock Check List.

Clinical Database Development
iuvo’s clinical databases are built on a Microsoft SQL-based platform. Study-specific screens, back-end tables, and automated edit checks are programmed and validated in accordance with the data management plan and 21 CFR part 11 requirements.

Clinical Data Entry, Data Processing, CRF Review, Query Resolution
Thanks to iuvo’s EDC system, study data is entered via a secure Internet connection by the study coordinator and automated edit checks ensure controls for data entry accuracy. During site monitoring visits, data entry accuracy is also confirmed by the visiting clinical research associate.

Completed CRFs, reviewed and collected in conjunction with monitoring site visits, are forwarded to iuvo where they are logged and double data entered into the database by two different team members, and discrepancies are adjudicated prior to finalization of entries. Data entry personal are specially trained on the specific data processing guidelines. Meanwhile, iuvo’s paper double entry functionality provides flexibility to sponsors who prefer a hybrid method of data collection.

Clinical Data Review & Query Resolution Data inconsistencies that are not detected by automated edit checks are reviewed per the In-House CRF Review Guideline. Using either paper or electronic DCFs, additional queries may be generated and transmitted to the study site.

Data Dictionary Processing
iuvo offers data coding services for adverse events, medications, and medical history. Typically using MedDRA and WHO DRUG, coding listings can be provided regularly for sponsor review.

Data Imports
Written data import protocols are co-developed with the central lab or reading center and submitted to the sponsor for approval.

Data Exports
Clinical study data can be easily exported into a number of formats including Excel spreadsheets, SAS datasets, ACCESS tables and ASCII files.

Data Quality Assurance
Typical data quality assurance procedures include generation and review of data inconsistency listings, confirmation of randomization schedules, data entry versus source data and resolution of data queries. Study data analysis and metrics can be provided to clients, as required, on an ongoing basis throughout the study conduct.

Database Lock and Data Transfer
Upon successful completion of necessary data quality assurance procedures and a data lock checklist, iuvo will lock the clinical study database and transfer the data to the designated biostatistician for analysis.

Database Maintenance and Archival
iuvo maintains all clinical databases through completion of the final clinical study report. At that time, all study data is transferred to our client in their designated format and archived as specified in the services agreement.

Security Procedures
Security is critical to credibility of the study. Clinical data security is enforced via use of a single user/password sign-on for qualified, registered database users. Specific access roles are granted as appropriate, and user passwords are changed at specified intervals. Audit trails of server and record access provide comprehensive tracking of modifications made to data or programming files.