In our efforts to provide the best statistical services, we try to stay integrated in the project from start to finish and work closely together with the sponsor to develop statistical plans that best support regulatory requirements while meeting sponsor's needs and standards in interpreting and presenting clinical data.
Our statistical services, which comply with regulatory requirements and ICH recommendations for statistical principals and reporting, include: writing statistical sections of preclinical and Phase I-IV protocols, sample size calculations and randomization schedules, statistical analysis plans (SAPs), specifications for case report tabulations, integrated summaries of safety and efficacy and statistical reports.
We have extensive experience in providing these services for NDA/sNDA/BLA/510K submissions as well as for product labeling, launch preparation and publication plans.
StatMinds LLC., combines appropriate validated software such as SAS®, S-Plus® and StatXact® with the expertise and experience so that the programs work for the sponsor in the most efficient way.
Specific areas of our expertise include:
PK/PD analysis
Design of Experiments – Including high order crossover designs
Regulatory presentations for FDA, EMEA agencies and local European Agencies
Medical Insurance
Dental Insurance
Vacation and sick Days
Relocation Allowance
We offer Per Diem Option
Visa Sponsorship
Medical Insurance
Dental Insurance
Relocation Allowance
We offer Per Diem Option
For some assignments, if a consultant owns a corporation with a federal tax ID number, we can pay them as a corporation.