Statistical Services

Biostatistics

Along with data management and EDC deployment, niAnalytics provides our clients with a full complement of biostatistical services. niAnalytics can fulfill any biostatistical service and/or analysis request. Our team of expert biostatisticians is comprised of PhD level researchers specialized in medical statistics, pharmacokinetics and pharmacodynamics, as well as population pharmacokinetics.

In association with our biostatisticians, niAnalytics professional medical writers can write your clinical trial statistical analysis plan and statistical analysis report according to IHC E3, IHC E9, and industry best practice guidelines.

Some of the statistical services we routinely provide are:

Sample size and
power calculations

Randomization

Statistical analysis
plan writing

Statistical analysis
report writing

Pharmacokinetics
and pharmacodynamics

Population
pharmacokinetics

We recommend to our clients to leverage the benefits of a vertically integrated data management strategy. It is incredible how easy and efficient the entire process becomes when the niAnalytics team follows your clinical trial from the protocol, to the creation and deployment of the eCRF and EDC documents, to data management, statistical analysis plan writing, statistical analysis, and all the way to the writing of the final statistical analysis report.

Sample Size and Power Calculations

We can perform sample size and power calculations for trials of any complexity. However, for simple sample size and power calculations, we are pleased to provide our sample size and power calculator free of charge.

For more complex sample size and power calculations please contact us for a quote.

Randomization

Randomization

Our niAnalytics EDC/CTMS system is preprogrammed with the most common randomization schedules including:

Simple randomization is the simplest and most frequently used algorithm. It can result in an imbalance between the groups, however with the large number of iterations our niAnalytics system can perform, it can usually provide the desired allocation ratio.
Random Sorting is applicable for any allocation type and any number of trial arms. This type of randomization can result in a significant imbalance in subject allocation over the course of the randomization process, but in the end it results in assignments which match the target groups.
Random Sorting Using Maximal Allowable Percent Deviation is similar to the random sorting algorithm however, the percentage of deviation at any point during the allocation process is limited by users’ specification.
Efron’s Biased Coin is only applicable for studies with two arms. It achieves longitudinal balance (dynamic changes of allocation probabilities) with a user specified probability parameter.
Smiths’s randomization is only applicable in studies with two arms. It achieves a longitudinal balance (dynamical changes of allocation probabilities) with a user specified exponent parameter.
Wei Urn randomization can be used in studies with two or more arms. It achieves longitudinal balance (dynamical changes of allocation probabilities) with a user specified A and B parameters.

If the above methods do not meet your needs, we will work with you to meet your randomization requirements, including randomization blocks and stratification.

Medical Writing

Medical Writing

At niAnalytics we employ expert medical writers who only work with data generated by the niAnalytics EDC/CTMS and which has been statistically analyzed by our team of biostatisticians. This level of inte- gration results in seamless information flow between our team members and an unprecedented level of efficiency.

Using data captured via our niAnalytics EDC/CTMS, managed by our staff, and analyzed by our biostatisticians our medical writers efficiently and professionally write essential trial documents, including:

The statistical analysis plan (SAP), which is prepared accordance with the industry best practice guidelines.
Interim statistical reports.
The final statistical analysis report (SAR) is written in accordance with ICH E3 guidelines and includes full patient listings and the annotated eCRF(s). Therefore, it is ready to be inserted into the final clinical study report.

Our medical writers have constant access to the eCRF and EDC documents as well as the statistical analysis and biostatisticians, thus ensuring that the resulting statistical analysis plan and statistical analysis report are written efficiently and with maximal precision.

Pharmacokinetics, Pharmacodynamics, and Population Pharmacokinetics

Pharmacokinetics

Pharmacokinetic, pharmacodynamic as well as population pharmacokinetic analyses are performed by PhD level experts in these fields. niAnalytics thus ensures that these complex analyses and their re- porting are performed with the care and expertise that they require.

If you require consultation regarding these analyses for your trial, please feel to contact us and we can even provide assistance with the set-up of the pharmacokinetic and pharmacodynamic analyses for your trial protocol.

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