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 CFR 21 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 real-time 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 staffs are very clear on how to complete the required pages. These can be incorporated into the document itself or be a standalone 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 • Medical coding
•  SAE Reconciliation • Handling of Local Lab and specialized lab settings
•  Integration with a client's existing systems & processes
•  External Data Upload (Central Lab, e-Diaries)
•  Reconciliation of external data specialized in IVRS, Biomarker, Central lab, ECG, Holter, MRI, and PG Samples.
•  CDISC Compliant Data Transfers
•  Data extracts • Data base lock and Archiving of the study documentation with database
•  Database freeze