Sponsors often need to overcome protocol design, data analysis and quality assurance challenges and need to be certain of providing satisfactory answers to regulatory bodies. Our consultancy services are provided on a case-by-case basis based on each client’s need.
Data Services Consultancy for Clinical Trials:
|Protocol Design & Statistical Methodology||Streamlining data management processes||Implementing Quality Management Systems|
|Adaptive Trial Design & Bayesian Framework||CDISC Implementation and Mapping Strategy||SOP and QA Manual Support|
|Making Sense of Clinical Data: Data Mining, Reporting||Guidance on EDC Technology selection||GxP and Internal Audit Support|
|Special Considerations for Oncology Trials||Global Data Strategy||Vendor Auditing|
|Support at DSMB Meetings and Meetings with Regulatory Agencies||Risk-Based Monitoring and Risk-Based Metrics||Data De-identification and Anonymization|
|Centralized Statistical Monitoring to facilitate RBM|