Need statistical expertise in designing/fine-tuning your regulatory submission pathway? Or in your interactions with FDA/EMA/UK/ROW regulatory agencies? Or you have questions regarding your overall submission data package?
Need statistical expertise to help implement creative thoughts into your clinical development plan? Or an efficient design which achieves the goals of your clinical study and fits into your overall clinical development plan?
Need a statistical mindset to help you lay out the analyses you need to support various goals on a daily basis? Achieving the ultimate goals of each clinical study in your clinical development? Efficiently utilizing your clinical data to support your goals at different stage per statistical principles?
Our CDISC experts have participated in the development of CDISC and can answer any questions that you may have regarding CDISC, and can help you set up your data capture, data structure in a more efficient way for later steps during data analysis and the final data submission to the agencies.
Similar to Programming standards, the corresponding standards are also set up for data capture -- CDASH. Our experts can help you design your CRF and database to align with the current version of the standards and be ready for future up-versioning. To be ready for submission from setup.
Do you sometimes wonder if someone can help you transcribe those beautiful numbers onto a figure/table for easier understanding?