Our primary service is supporting biotech and pharmaceutical companies in their CDISC data submissions for licensing applications. A typical New Drug Application (NDA) and Biologics License Application (BLA) project begins with strategic consultation and a careful inventory of existing study data and supporting documentation. Most study data require some remediation prior to an NDA or BLA filing. We develop a scope of work that details what it will take to deliver the data package to the Food and Drug Administration (FDA). From that scope we develop a plan to utilize client in-house programming and statistician resources and/or outside contract research organizations (CRO). We then develop a request for proposal, aid in the CRO selection, and provide vendor oversight including evaluating deliverables. We drive projects to completion with quality through technical and regulatory know-how in the evaluation of eSubmission data packages.
eSubmission Readiness Consulting
- Inventory and gap analysis of clinical study data and documents for NDAs and BLAs
- Evaluate data packages for eSubmission readiness
- Write the Study Data Standardization Plan
- Develop biometrics and regulatory scope of work to achieve study data submission
- Write requests for proposals and manage the selection process of clinical research organizations (CROs)
- Manage CROs and verify deliverables
- CDISC implementation consultation and review of data mapping strategies
- Verify data packages to ensure CDISC compliance and FDA guidance
- Review FDA information requests concerning data submission packages and write responses
Biometric Infrastructure Development
- Develop biometric methods and processes to improve dataflow and communication between sponsor departments (biostatistics, non-clinical group, clinical operations, pharmacovigilance, and regulatory)
- Improve and document dataflow between sponsor and vendors
- Improve infrastructure through team building support and training
- Technically screen biometrics candidates
- Formalize biostatistical processes and procedures into guidelines and SOPs
Affiliate Consultant Statistical Services
- Sponsor statistician representation
- Blinded statistician services
- Statistical review of integrated analysis and submission strategy
- Writing statistical analysis plans and statistical sections for protocols and clinical study reports