Services

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

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  • 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

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  • 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

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  • 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