A US biotech company prepared their NDA and wanted an Independent Biostatistical review of all data and Statistical requirements, including the CDSIC coding performed by the CRO, prior to submission to the FDA in order to prevent a Technical Rejection.
EmpiriStat was contracted to review the NDA submission package. EmpiriStat Principal Biostatistician, Dr. Nicole C. Close, who has extensive U.S. Regulatory experience, along with EmpiriStat's team of statistical programmers conducted a thorough review and conducted CDSIC validation.
The biotech company was provided with a detailed Statistical Risk Analysis summary and an independent assessment indicating that the company would have received a Technical Rejection upon submission. EmpiriStat was also contracted to Rescue the NDA submission, and to conduct all new CDSIC coding for each of the clinical studies, the ISS and the ISE for the NDA filing.
EmpiriStat support the PAI in the front room, and assisted with back room preparations. They participated in all mock audits, and performed on call analyses for the FDA inspector. The product was approved in the United States.
Further, EmpiriStat has also assisted the client with the submission of the MAA in Europe, Day 120 preparations, and the NDS in Canada.
The product was approved in the US and in Europe!
A pharmaceutical company was only months away from filing their NA with the FDA. They did not have an in-house Biostatistics/Statistical Programming group for review and writing of the ISS SAP and to conduct validation programming for their program. None of the studies were CDISC coded.
EmpiriStat collaborated with the company and provided all of the services required as the Sponsor's in-house Biostatistics and Statistical Programming group to support both the ISS and NDA filing within a very condensed timeframe without compromising quality.
The Company received biostatistical guidance, writing, reviewing and statistical validation programming from EmpiriStat to complete the filing within the existing company timelines. The company saved time and money by consulting with EmpiriStat who provided flexible, time efficient and cost-effective services in an expedited manner set by the client's needs.
The product was approved!
The client had contracted with EmpiriStat for part-time Senior Clinical and Regulatory Affairs Management and expertise. The client was also in the process of contracting for a full service CRO to provide Data Management, Clinical Monitoring, Safety Reporting, Biostatistics, and Regulatory support for their multi-center clinical trial. However, the client was having contracting difficulties and the trial timelines were being delayed.
EmpiriStat was contracted by client to expand their current services to provide a Bridge until the CRO could be selected and contracted. In a condensed timeline of just 4 months, EmpiriStat created the deliverables and provided the on-site professionals to initiate the clinical trial (including complete Case Report Forms, Manual of Procedures, a Safety Reporting System, Study Specific Procedures for a Data and Safety Monitoring Board, all training modules, Clinical Monitoring Plan and 2 certified research coordinators and one professional consultant). A clear transition plan was developed between EmpiriStat's bridge of services to the CRO.
The client moved forward with the deliverables required to initiate the trial without further delay, had no cost or delay associated with a new group getting up to speed on the trial since EmpiriStat was currently providing management guidance, and saved time and money when the CRO was hired since all primary deliverables had been created for the study.
A European device company was preparing for filing with the U.S. FDA with a device already approved in Europe. They had consulted with an academic Biostatistician in the U.S., but were unsure of the analyses and recommendations that the Biostatistician had made and was looking for an independent opinion.
EmpiriStat was consulted to review the statistical analyses and recommendations and to provide their own assessment prior to the company filing. EmpiriStat Principal Biostatistician, Dr. Nicole C. Close, who has extensive U.S. Regulatory experience, along with an EmpiriStat Statistician located in the United Kingdom who is well versed in EMEA guidance, reviewed the information and provided a detailed Statistical Risk Analysis for the filing.
The device company was provided with a detailed Statistical Risk Analysis summary and an independent assessment. The company made modifications to their filing based on EmpiriStat's recommendations and successfully filed with the U.S. FDA.