SERVICES
Data Management
Data Management Consulting:
Support study planning to ensure the client remains efficient and competitive. Data is a valuable asset, and with correct planning and analysis, Clindata can maximize the information derived from it.
Data Capture Form Design & Review:
Create forms to ensure data entry is streamlined as much as possible for both paper and EDC studies.
Database Design, Build, and Validation:
Databases are built by Clindata programmers using the study protocol as a guide to developing query specifications, roles, and schedule specifications. The Data Team Lead coordinates the validation effort and prepares the Validation Plan, which includes predefined test scripts for verification, as well as internal and external user acceptance testing. The Data Team Lead also compiles the Validation Report.
Database Change Management:
Database feasibility checks and maintenance to ensure it remains compliant and validated.
Data Entry & Tracking:
The raw data is tracked to ensure all observations have been received and entered. Study data entry could involve a single entry with 100% Quality Control (QC), a double entry with 100% QC of the critical datasets and 100% QC on a random 10% of the remaining datasets, or according to a customized sponsor’s request.
Data Reconciliation:
Laboratory data can be reconciled with the source data by the EDC system or manually using Clindata analysis tools.
Study Status Reports and Data Verification (Manual & Automated Edit Checks):
Data cleaning/review consists of using query checks, with queries generated automatically in the system or manually created by the Data Team Lead. A query report comprised 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):
Clindata’s experienced team performed Computer system validation on all software used or programmed by the Clinglobal group. Ensuring the quality of computer systems and the performance and compliance of electronic data capturing and handling software is critical to data integrity and quality.
Biostatistics
Statistical Programming
Clindata programmers create core analysis datasets to serve as central datasets for the raw data and analyzable variables. These are derived from the raw datasets using the specifications and double-programmed by the programming team. The derived analysis datasets are used as sources to produce the statistical summaries such as tables, listings, and figures.
Clindata provides clients with a description of the electronic data files submitted and data processing procedures used to create the statistical outputs of the study in a format accepted by the regulatory authorities. The process is summarized in a ReadMe file and encryption keys for all files submitted.
Delivery Models
Project-Based Delivery Model:
Clindata is contracted for a specific project or study where the scope, timeline, and deliverables are clearly defined. We manage all aspects of the project, including resources and execution, from start to finish. This model is ideal for clients needing expertise for one-off studies or specific research phases.
Dedicated Resources Delivery Model:
Clindata provides dedicated personnel who work exclusively on a specific client’s projects. These resources act as an extension of the client’s in-house team, allowing for greater control and alignment with the client’s processes and goals. This model is suitable for clients with ongoing needs, requiring consistent support across multiple projects or phases.
Functional Service Provider (FSP) Delivery Model:
In the FSP model, Clindata offers specialized services such as Data Management and Statistical Programming rather than managing an entire project. Clindata functions as a partner, delivering specific functions or the full scope across multiple studies or programs. This model provides flexibility, scalability, and enables clients to maintain oversight of their broader program while outsourcing specific tasks.