The ClinDatrix Data Management team, led by Denise Redvers-Higgins, collaborates with our clients to tailor project approaches that best meet each client’s needs and to ensure timely and reliable data analysis. We leverage quality processes and project specific data management documentation to produce accurate and robust clinical databases for analysis and reporting.
Every project and every contract is unique, and each client calls on us to provide services tailored to their specific needs. Our clients contract us for the data management services they need to complete their studies to their timelines with the added value of our experience and expertise.
Data Management Plan
ClinDatrix prepares a comprehensive road map for the data management tasks of the clinical project. Included in the data management plan are a contact matrix, a project timeline, a description of systems and processes used, a CRF (case report form) or eCRF (electronic CRF) flow diagram, and a responsibility matrix. The data management plan provides documentation to the project team on the planned conduct of the data management component of the clinical investigation. The data management plan may be generated from a template provided by the client or from the ClinDatrix standard template.
ClinDatrix works in partnership with our clients throughout the project to jointly achieve the goals of the clinical investigation. The assigned data management project manager uses several methods of communication to facilitate this partnership including documentation (e.g., data management plan, contact matrix, timeline, project specific processes and procedures); correspondence by memo and e-mail; teleconferences and face-to-face meetings; and standard and customized status reports delivered per an agreed-upon schedule.
Review of Clinical Protocols and CRFs/eCRFs
ClinDatrix provides experienced, in-depth review of the clinical protocol and supporting CRFs or eCRFs, examining the documents for consistency, completeness, accuracy and suitability to capture the data required to meet the clinical investigation objectives.
ClinDatrix designs and generates study protocols based on client input and best practices. The process involves multiple stages of review and relies on the expertise of our Clinical, Data Management, Biostatistics, Medical Safety and Quality Assurance teams. A protocol timeline is developed and closely adhered to so that we meet our clients’ schedules through every step of the process, from protocol synopsis to final protocol approval.
ClinDatrix designs CRFs/eCRFs to accurately and completely capture the data required by the clinical protocol, paying attention to ease of use by the site staff, the clinical monitor, the data manager and the biostatistician. We work closely with our clients to meet all the requirements and expectations for the study. CRF/eCRF design may be based on mock-ups provided by the client or on ClinDatrix standard CRF/eCRF templates.
Project Documentation – Project Specific Procedures
ClinDatrix sets up and maintains a project binder and project files to contain all documentation for the data management component of the clinical project. Included in the project binder and project files are protocol specific procedures customized for the clinical protocol. The protocol specific procedures supplement our full suite of ClinDatrix data management SOPs.
Database Design and Development
ClinDatrix designs the clinical database utilizing technology to ensure the accurate and complete capture of data from the CRFs/eCRFs for the clinical protocol. The clinical database will employ CDASH standard naming conventions. ClinDatrix is a Gold Member of CDISC.
Electronic Data Capture
ClinDatrix has Oracle InForm in a private cloud in Irvine, CA. InForm, with its companion products Central Designer, Central Coding and CRF Submit provide a market leading EDC solution for our clients. Using an IBM Cognos Business Intelligence reporting engine, InForm delivers unsurpassed reporting capability. Both pre-defined reports and ad hoc reports can be delivered with ease.
Double Independent Data Entry
For paper-based studies, ClinDatrix uses Oracle Clinical to enter and manage data collected on paper CRFs. Two data entry processors conduct first and second pass data entry independently. An experienced data manager then reviews the comparison report between the first and second pass data entry and determines the correct database entry in the case of mismatches. ClinDatrix uses Oracle Clinical to enter and manage data collected on paper CRFs.
Data Edit Specifications and Edit Reports
Edit specifications are written, reviewed and programmed. All of the edit checks are tested before being used to validate the data in the database. The edit specifications are detailed to include the logical checks as well as the messages generated when the data fail the logical checks. The messages form the basis for the edit reports to be used during the manual review of the clinical data.
Data Review Listings
The data review process makes use of not only edit reports but also clinical data review listings in order to inspect all aspects of the data: point-to-point data comparison, data across visits per patient, data across patients per site and data across the study as a whole. The appropriate data review listings are described and specified in each project’s Clinical Data Review Manual.
Our experienced and knowledgeable staff code selected verbatim text utilizing industry standard dictionaries (e.g., MedDRA and WHO Drug) and/or customized dictionaries provided to ClinDatrix by our clients. An intelligent auto-encoder first performs an automated coding for all direct hits. This step is followed by a manual coding for all verbatim text not auto-encoded. Coding listings are reviewed by ClinDatrix and provided to the client for review and approval prior to declaring the coding activity complete, accurate and final.
Quality Control – Data Quality Reviews
ClinDatrix builds in quality throughout the data management process. For studies using paper CRFs, a 10% random sample of patient visit data is inspected at designated time points (as defined in the data management plan) by comparing data listings generated from the database against the CRFs. In addition, 100% of critical data variables also undergo similar visual inspection. The database passes quality control when the error rate is less than or equal to 0.05%.
Validation of Database Design and Development, Edit Reports and Data Review Listings Databases
ClinDatrix tests and verifies the database design, edit reports and data review listings to ensure accuracy and completeness.
Electronic Data Transfers
Data is transferred to the client per client specifications in the format required by client systems. As needed, programs are written and verified to produce the custom data transfers. Prior to any official electronic data transfer to our clients, we perform a test transfer to confirm that the format of the data files matches the client specifications and that the transfer process is error-free.
Electronic Data Handling
ClinDatrix incorporates laboratory data, pharmacokinetic data, visual field data and any other electronic data into the final datasets and listings generated for our clients. Validation checks are designed to verify the accuracy of the patient identification data from these electronic sources compared against the clinical data collected on the CRFs/eCRFs.
Data Backups and Archival
ClinDatrix regularly backs up the clinical data per our standard operating procedure. Backups are stored both on- and off-site in an appropriate secure and media safe environment that enables speedy and accurate retrieval of the data, should the need arise.
Disaster Recovery Site
ClinDatrix has a well-rehearsed disaster recovery plan using company owned servers at a SOC1/SSAE16 type II certified data center in Las Vegas, NV, which is 430 miles from our headquarters in Irvine, CA. Las Vegas was chosen because of its very low incidence of natural disasters. The ClinDatrix IT department rehearses complete server recovery twice per year with a recovery time objective of eight hours.
Online Data Viewing
ClinDatrix uses a secure site (sFTP) to post CRF images, tables, listings and reports. Clients log in to the site with a password and may download reports from or upload data to their private designated folder on our network.