G7 Synergon has an experienced Data Management team, which recognizes the importance of a smooth interface with CRAs, Project Managers, Clients and Investigational sites. We ensure that the clinical data

 to be submitted to regulatory authorities is collected by using validated systems (Oracle Clinical Version - 4.6) that complies with FDA 21CFR Part 11 and GCP standards.

G7 Synergon offers Clinical Data Management services from Phase I (early clinical development) to late Phase IV clinical studies with proven expertise in supporting global clinical trials. Our mission is to deliver rapid study start up and streamlined workflow that improves data collection with real time access to the data, with reporting capabilities to provide visibility into the study.

We have defined metrics and turnaround times for each step of our processes from database build and entry to query resolution and QC. This allows us to efficiently manage our time and ensure that we provide you with accurate costs right at the commencement of any study, which minimizes change orders. CRF/ eCRF completion guidelines are prepared alongside the design of the CRF to ensure that site staff are very clear on how to complete the required pages. These can be incorporated into the document itself or can be a stand-alone document.

Clinical Data Management services include: Paper and Electronic Data Capture (EDC) studies

• Preparation of Data Management Plan
•CRF designing and Annotations
• Database design and Validation programming
• User Acceptance Testing
• Scanning and Indexing (paper studies)
• Double Data entry (paper studies)
• Discrepancy management & Query Resolution
• Dictionary Coding (TMS)
• External Data Upload (Central Lab, e-Diaries)
• Reconciliation of external data specialized in IVRS, Biomarker, Central lab, ECG, Holter, MRI, and PG Samples
• SAE Reconciliation
• Integration with a client's existing systems & processes
• Handling of local lab and specialized lab settings
• CDISC Compliant Data Transfers
• Data extracts
• Data base lock and Archiving of the study documentation with database
• Database freeze

Team Experience

The Clinical Data Management team has work experience under various therapeutic areas like Oncology, Transplantation, Osteoarthritis, Respiratory diseases, Hypertension, Cardiology, Medical Device, Neuroscience and Vaccines under different platforms like Oracle Clinical- Paper CRF’s, Remote Data Capture, Electronic Data Capture (Phosco as well as Rave). We have successfully completed FDA projects and DCGI projects within 1 year of the department development.

Subject matter experts for SAE Reconciliation have executed third party reconciliations like Biomarkers, ECG, Central Labs, Local Labs and SAE Reconciliation. We have successfully locked multiple trials, submitted clean data for Interim Analysis, BIQR’s, TRTD Analysis and Baseline Abstracts.